Bringing Clarity To Radiopharmaceuticals

Date Theme Sector
13 September 2022 Initiation of Coverage Healthcare
Company
Clarity Pharmaceuticals (CU6)
Bringing Clarity to radiopharmaceuticals

OVERWEIGHT
Recommendation
12-mth target price (AUD) $0.82

We initiate coverage on Clarity Pharmaceuticals with an OVERWEIGHT rating and $0.82/sh Share price @ 12-Sep-22 (AUD) $0.66
risked PT. Clarity has played a clever and patient game in nuclear medicine, ensuring the two Forecast 12-mth capital return 25.2%
most important factors for success, are in place. Those being: a) technology which secures copper Forecast 12-mth dividend yield 0.0%
(64Cu & 67Cu) without leakage and b) commercial production of 67Cu for use in therapy. There is a 12-mth total shareholder return 25.2%
renaissance in copper-based radiopharmaceuticals and with tightly bound intellectual property,
Clarity leads it. The company’s conviction is demonstrated by taking on all comers in the cancer
indications that have built the industry: neuroendocrine tumours (NETs) and prostate cancer. Market cap ($m) 118.6
Strategically, Clarity’s capabilities in copper also offers Pharma an entry point into Enterprise value ($m) 26.3
radiopharmaceutical development providing alternatives to the current isotope mainstays (18F, Shares on issue (m) 181.1
68Ga and 177Lu), each with different limitations. A theranostic program for both neuroblastoma
Sold short (%) 0.0
(NB) and a ‘pan cancer’ agent, based on a bombesin analogue, completes the asset portfolio. ASX All Ords weight (%) 0.0
Median turnover/day ($m) 0.1
 Key points
Clarity to harness easing availability of Copper isotopes. Copper isotopes (64Cu & 67Cu) have long
been sought after by scientists for their somewhat perfect chemistry and pairing. The lack of safe Dr Melissa Benson
use and thus, production of these isotopes (namely 67Cu) however, has hindered translation from melissa.benson@wilsonsadvisory.com.au
the research benchtop into clinical practice. Clarity’s technology has changed this paradigm with Tel. +61 2 8247 6639
67Cu production at the precipice of commercialisation capability and exclusive supply agreements
already in place. In this way Clarity will take advantage of the issues continuing to surround Dr Shane Storey
traditional isotopes (18F, 68Ga, 177Lu), offering accessible and sustainable solutions for a rapidly shane.storey@wilsonsadvisory.com.au
expanding radiopharmaceutical market. Tel. +61 7 3212 1351
Primely positioned for a heated radiopharmaceutical market. Clarity have bolstered their appeal Madeleine Williams
using their innovative SAR technology to stably retain copper isotopes (64Cu & 67Cu) across key madeleine.williams@wilsonsadvisory.com.au
indications (including prostate cancer and NETs). This presents as an attractive target for pharma Tel. +61 3 9640 3834
oncology players (Merck, Roche) yet to have a position within the nuclear medicine space. To
compete with Novartis, others will look to take footholds with CU6 presenting a desirable IP 12-mth price performance ($)
package and clear differentiation from other players for pharma market entry.
1.40
Strategy to execute on rare disease indications and support larger long-term opportunities. 1.20
Clarity will look to first establish their proprietary technology in neuroblastoma (NB) supported
1.00
by two orphan drug designations driving two potential priority review vouchers (~$100M value
each). This may allow Clarity to materially increase early revenue generation providing both a) 0.80
funding and b) evidence for their main-revenue contributing programs in prostate cancer. 0.60
Forecasts. FY25e represents first commercial revenue via NB. In the near term, we see licensing 0.40
deals as value realisation points for NETs and prostate programs. Indication peak sales are 0.20
assessed as: a) $1.8b for PSMA negative prostate cancer (Dx + Tx); b) $1b for PSMA(+) prostate Sep-21 Jan-22 May-22 Sep-22
cancer (Dx + Tx); c) $155m NETs (Dx only); and d) $130m NB (Dx + Tx). CU6 XAO
Valuation. Our $0.82/sh risked SOTP valuation utilizes real-options DCF for key pipeline 1-mth 6-mth 12-mth
programs; a) prostate $0.63/sh; b) NB $0.10/sh; and c) NETs $0.09/sh. No value is attributed to Abs return (%) 4.8 23.6 (51.5)
the breast cancer Dx program at present. Unrisked PT is $4.07/share. Near term clinical readouts
Rel return (%) 7.0 27.1 (47.6)
(next 6 months) de-risk our valuation by ~20% to $0.98/sh.
Financial summary (Y/E Jun, AUD) FY21A FY22A FY23E FY24E FY25E Key changes 0-Jan After Var %
EBITDA norm ($m) (10.2) (23.8) (23.9) (26.5) (44.9) EBITDA FY23E (23.9)
Consensus EBITDA ($m) (27.2) (35.1) 142.3 norm FY24E (26.5)
EPS norm (cents) (5.8) (10.0) (9.9) (11.0) (14.2) ($m) FY25E (44.9)
EV/EBITDA (x) n/m n/m n/m n/m n/m EPS FY23E (9.9)
FCF yield (%) (6.7) (7.3) (14.1) (14.5) (19.0) norm FY24E (11.0)
(cents) FY25E (14.2)
Source: Company data, Wilsons estimate, Refinitiv.
Price target 0.82
All amounts are in Australian Dollar (A$) unless otherwise stated.
Rating O/W
Wilsons Equity Research

Analyst(s) who owns shares in the Company: n/a Issued by Wilsons Advisory and Stockbroking Limited (Wilsons) ABN 68 010 529 665 – Australian Financial Services
Licence No 238375, a participant of ASX Group and should be read in conjunction with the disclosures and disclaimer in this report. Important disclosures regarding companies
that are subject of this report and an explanation of recommendations can be found at the end of this document.
13 September 2022 Healthcare
Clarity Pharmaceuticals Limited
 Business Description  Investment Thesis

Clarity is a clinical stage radiopharmaceutical company developing next- We initiate coverage on CU6 with an OVERWEIGHT rating and $0.82/sh
generation theranostic (therapy and imaging) products, based on their risked PT. Clarity has played a clever and patient game in nuclear medicine,
proprietary SAR technology. SAR technology unlocks the use of copper driving technology advances to allow 67Cu to become commercially
isotopes enabling superior imaging and therapeutic characteristics of available. A proprietary position in 67Cu therapeutics completes a perfect
radiopharmaceutical products. With this combination, Clarity aim to address ‘theranostic pair’ with 64Cu for diagnostics. Strategically, Clarity’s
the current manufacturing and logistical limitations in the growth of the capabilities in copper offers Pharma an entry point into radiopharmaceutical
radiopharmaceutical sector in oncology. development with a unique and compelling offering.
 Catalysts  Risks
a) achievement of trial endpoints; b) partnership opportunities; c) regulatory a) unfavourable clinical trial results; b) reliance on third parties to advance
approvals. asset development; c) competitive intensity of radiopharmaceutical market;
d) unfavourable markets.
P&L ($m) FY21A FY22A FY23E FY24E FY25E Balance sheet ($m) FY21A FY22A FY23E FY24E FY25E
Sales 0.0 0.0 0.0 0.0 0.2 Cash & equivalents 18.9 92.3 66.3 39.6 60.3
EBITDA norm (10.2) (23.8) (23.9) (26.5) (44.9) Current receivables 3.4 6.7 5.0 5.0 5.0
EBIT norm (10.2) (23.8) (24.0) (26.6) (45.0) Current inventory 0.0 0.0 0.0 0.0 0.0
PBT norm (10.2) (23.7) (23.6) (26.3) (44.7) PPE 0.1 0.3 0.6 1.0 1.3
NPAT norm (10.2) (23.8) (23.6) (26.3) (44.7) Total assets 22.6 99.8 72.5 46.2 67.2
NPAT reported (10.4) (23.8) (23.6) (26.3) (44.7) Current payables 1.8 6.8 2.5 2.8 4.2
EPS norm (cents) (5.8) (10.0) (9.9) (11.0) (14.2) Total debt 0.0 0.0 0.0 0.0 0.0
DPS (cents) 0.0 0.0 0.0 0.0 0.0 Total liabilities 2.3 7.6 2.9 3.4 5.5
Shareholders equity 20.3 92.2 69.6 42.8 61.7
Growth (%) FY21A FY22A FY23E FY24E FY25E
Sales n/m n/m n/m n/m n/m Cash flow ($m) FY21A FY22A FY23E FY24E FY25E
EBITDA norm 45.5 132.8 0.5 10.9 69.2 Operating cash flow (7.7) (13.3) (25.6) (26.3) (44.7)
NPAT norm 45.9 133.2 (0.5) 11.5 69.6 Maintenance capex (0.1) (0.2) (0.4) (0.4) (0.4)
EPS norm (cents) (80.2) 72.5 (0.5) 11.5 28.5 Free cash flow (7.7) (13.5) (26.0) (26.7) (45.1)
DPS (cents) n/m n/m n/m n/m n/m Growth capex 0.0 0.0 0.0 0.0 0.0
Acquisitions/disposals 0.0 0.0 0.0 0.0 0.0
Margins and returns (%) FY21A FY22A FY23E FY24E FY25E Dividends paid 0.0 0.0 0.0 0.0 0.0
Other cash flow (0.7) (32.1) 12.0 5.0 0.0
Interims ($m) 2H21A 1H22A 2H22A 1H23E 2H23E Cash flow pre-financing (8.4) (45.6) (14.0) (21.7) (45.1)
Sales 0.0 0.0 0.0 0.0 0.0 Funded by equity 20.9 92.1 0.0 0.0 65.8
EBITDA norm (5.4) (13.7) (10.1) (12.2) (11.7) Funded by cash/debt (24.0) (139.0) 26.0 26.7 (86.5)
EBIT norm (5.4) (13.7) (10.1) (12.3) (11.7)
PBT norm (5.3) (13.7) (10.0) (12.1) (11.6) Liquidity FY21A FY22A FY23E FY24E FY25E
NPAT norm (5.3) (13.7) (10.0) (12.1) (11.6) Cash conversion (%) 75.6 56.2 108.4 100.1 100.2
NPAT reported (5.4) (13.7) (10.0) (12.1) (11.6) Net debt ($m) (18.9) (92.3) (66.3) (39.6) (60.3)
EPS norm (cents) (3.0) (5.8) (4.2) (5.1) (4.8) Net debt / EBITDA (x) 1.9 3.9 2.8 1.5 1.3
DPS (cents) 0.0 0.0 0.0 0.0 0.0 ND / ND + Equity (%) n/m n/m n/m n/m n/m
EBIT / Interest expense (x) n/m n/m 70.3 n/m n/m
Stock specific FY21A FY22A FY23E FY24E FY25E
R&D expenditure (9.7) (18.9) (23.5) (25.0) (27.7) Valuation FY21A FY22A FY23E FY24E FY25E
EV / Sales (x) n/m n/m n/m n/m n/m
EV / EBITDA (x) n/m n/m n/m n/m n/m
EV / EBIT (x) n/m n/m n/m n/m n/m
P / E (x) n/m n/m n/m n/m n/m
P / BV (x) 5.7 2.0 2.6 4.3 3.9
FCF yield (%) (6.7) (7.3) (14.1) (14.5) (19.0)
Dividend yield (%) 0.0 0.0 0.0 0.0 0.0
Payout ratio (%) 0.0 0.0 0.0 0.0 0.0
Weighted shares (m) 176.5 238.6 238.7 238.7 315.2
Source: Company data, Wilsons estimate, Refinitiv.

All amounts are in Australian Dollar (A$) unless otherwise stated.
Wilsons Equity Research Page 2

Contents
 Key points ..............................................................................................................................................................................................................................................................................1
Glossary ..............................................................................................................................................................................................................................................................................................4
1. Investment Thesis...............................................................................................................................................................................................................................................................5
 1.1 Investment merits........................................................................................................................................................................................................................................................5
 1.2 Investment risks ...........................................................................................................................................................................................................................................................7
 1.3 ESG considerations .....................................................................................................................................................................................................................................................8
2. Clarity Pharmaceuticals: company overview and background...........................................................................................................................................................................9
 Genesis, therapeutic field and objectives...................................................................................................................................................................................................................9
3. Valuation..............................................................................................................................................................................................................................................................................11
 3.1 Risked price target = $0.82 per share...............................................................................................................................................................................................................11
 3.2 Valuation sensitivities .............................................................................................................................................................................................................................................12
 3.3 M&A Transactions within the radiopharmaceutical space ........................................................................................................................................................................14
4. Forecasts..............................................................................................................................................................................................................................................................................15
 4.1 SARTATE.....................................................................................................................................................................................................................................................................16
 4.2 SAR-bisPSMA............................................................................................................................................................................................................................................................17
 4.3 Investment and expense assumptions .............................................................................................................................................................................................................19
Appendices......................................................................................................................................................................................................................................................................................20
Appendix 1: Characteristics of Clarity’s molecules ..........................................................................................................................................................................................................21
 A1.1 Benefits of using 64Cu/67Cu................................................................................................................................................................................................................................21
 A1.2 Clarity’s three focus ligands under development......................................................................................................................................................................................23
Appendix 2: Clinical overview and competitive positioning .........................................................................................................................................................................................24
 A2.1 Neuroendocrine tumours (NETs) .....................................................................................................................................................................................................................24
 A2.2 Neuroblastoma (NB).............................................................................................................................................................................................................................................29
 A2.3 PSMA-positive prostate cancer........................................................................................................................................................................................................................36
 A.2.4 GRPr-positive prostate cancer.........................................................................................................................................................................................................................44
 A2.5 Breast cancer...........................................................................................................................................................................................................................................................46
Appendix 3. Additional valuation and forecast detail .....................................................................................................................................................................................................48
 A3.1 Real-options valuations for Clarity’s individual programs .....................................................................................................................................................................48
 A3.2 Forecast assumptions ..........................................................................................................................................................................................................................................51
 A3.2.1 SARTATE..............................................................................................................................................................................................................................................................51
 A3.2.2 SAR-bisPSMA.....................................................................................................................................................................................................................................................51
 A3.2.3 SAR-Bombesin ...................................................................................................................................................................................................................................................52
Appendix 4: Copper isotope production...............................................................................................................................................................................................................................53
Appendix 5: Deals in the radiopharmaceutical sector.....................................................................................................................................................................................................56
 A5.1 Rare disease designation and priority review voucher program..........................................................................................................................................................56
 A5.2 M&A deals in the space ......................................................................................................................................................................................................................................57
Appendix 6: Intellectual Property Summary.......................................................................................................................................................................................................................58
Appendix 7: Board and Management ...................................................................................................................................................................................................................................61
 A7.1 Board..........................................................................................................................................................................................................................................................................61
 A7.2 Management ...........................................................................................................................................................................................................................................................62
 A7.3 Scientific Advisory Board....................................................................................................................................................................................................................................63

Glossary
Beta/alpha emission Forms of emission released by radioisotopes (Beta: 177Lu, 67Cu, Alpha: 225Ac) which provide different
characteristics in treatment outcomes and toxicity.
Biochemical recurrence A rise in the blood level of PSA (prostate-specific antigen) in prostate cancer patients after treatment with
surgery or radiation, which may indicate returned disease.
Biodistribution Where, in the body the diagnostic and therapy agents travel to.
Bombesin A peptide found in the nerves of the gastrointestinal tracts that stimulates the release of gastrin.
Chelator A chemical compound that reacts with metals to form stable complexes, acting almost like a cage.
Cyclotron A type of particle accelerator responsible for producing radioisotopes such as 64Cu.
Gastroenteropancreatic General area in the body including along gastrointestinal tract (stomach, small intestine, colon etc.) and
pancreas.
NB Neuroblastoma (NB) is rare form of cancer that immature nerve tissue in infants and children. It is a rare cancer
however represents the most common form of solid tumours outside of the brain in children.
NETs Neuroendocrine tumours (NETs) are cancers which arise from neuroendocrine cells most commonly in the
digestive or respiratory tract. The main function of neuroendocrine cells in the body is to create, store and
secrete a variety of peptides (little proteins) and hormones for normal bodily functions.
Pharmacokinetics Describes how the drug moves through the human body i.e. the distribution throughout the body, how it is
excreted.
PET Positron Emission Tomography (PET) is a form of diagnostic imaging that is used to show areas based on
Positron Particles (found inside radioisotopes like 64Cu) which are emitted in order for an image to be produced on a PET
scanner.
PRRT Peptide Receptor Radionuclide Therapy was a term developed to describe the use of 177Lu in the targeted
radiotherapy treatment of neuroendocrine tumours (NETs).
Rhodotron A form of electron accelerator which is suited to applications which need a powerful beam such as in the
production of 67Cu.
SAR platform/technology Clarity's proprietary technology in the form of a chelator (cage) which securely holds the copper isotopes. SAR
is short for sarcophagine, which is a type of chelator.
SPECT Another form of imaging which uses different radioisotopes (to detect gamma rays instead of positrons in PET).
SPECT have far less image resolution.
SSTR2 Somatostatin receptor 2 (SSRT2) is a key target of Clarity’s SARTATE products. This receptor is a known
diagnostic marker to bind tumour cells (e.g. in NB and NETs).
SUVmax The maximum standardized uptake value (SUVmax) is a measurement of radioisotope-based agent in tissue.
T½ Denotes half-life - the time required for a quantity of a radioisotope to decay by half.
Theranostic A term used to describe the combination of using one drug attached to an imaging radioisotope to identify
(diagnose) cancer paired with the same drug coupled to a therapeutic radioisotope to deliver cancer therapy.

1. Investment Thesis
Clarity Pharmaceuticals is a combination of well-grounded science and right timing. They enter the nuclear medicine
market armed with three unique strengths:
1. A set of copper isotopes (64Cu & 67Cu) offering logistical and clinical benefits over traditional pairings that
currently dominate the market;
2. A tightly wrapped IP portfolio, particularly for their innovative SAR platform which separates and solidifies
their technology from peers; and
3. Newly developed copper production methods which allow for commercial scale manufacture and are
attracting industry investment following ongoing shortages in mainstay isotopes (e.g. 18F, 177Lu).
With these benefits in play, Clarity has been designed to firstly, enter into untouched markets (Neuroblastoma) driving
early revenue wins, as well as validating their copper-SAR platform. Secondly, Clarity has an opportunity in established
markets (PSMA prostate cancer, Neuroendocrine tumours [NETs]) to prove the benefits associated with their science and
technology. Thirdly, they will expand use in currently underserved populations (PSMA-negative prostate cancer) which
will solidify their standing amongst radiopharmaceutical peers.
Whilst Clarity sits at a relatively earlier development stage compared to its competitors, their assets position them as an
attractive opportunity for oncology Pharma players (i.e. Roche, Merck). These companies will look to bolster their market
positioning with a stake in the radiopharmaceutical space, following the success established by Novartis and others. The
slew of deals which we have witnessed in recent years confirm this.
 1.1 Investment merits
Proprietary technology enabling copper isotopes as the perfect theranostic pair. Clarity Pharmaceuticals is a concept
stock based on a suite of chemistry patents that enable the commercial-scale radiopharmaceutical development of
copper radio-isotopes (64Cu & 67Cu). The nuclear medicine field has long admired the potential for 64Cu and 67Cu as a
perfect ‘theranostic pair’ for diagnostic imaging and radionuclide therapy, respectively. Progress to date has been slow
owing to: a) the difficulty in manufacturing 67Cu with the requisite volume and purity; and b) neither isotope forms stable
molecules when paired with the conventional radiopharmaceutical ‘toolkit’ rendering copper medically useless. Clarity’s
core IP is novel synthetic chemistry that solves the second and most important aspect. Novel, cage-like structures, called
chelators, hold both 64Cu and 67Cu stable in vivo and in a structure that can be conjugated with cancer targets (Figure 1).
This IP unleashes the commercial potential of copper radioisotopes in pharmaceutical development.
Figure 1: Clarity’s proprietary SAR technology platform retains radioisotopes 64Cu for diagnosis and 67Cu for therapy
Source: Clarity Pharmaceuticals.

Manufacturing hurdles easing making way for CU6. The broader industry has made strong progress towards
commercially relevant 67Cu manufacturing. Several groups (including Clarity’s exclusive partner NorthStar Medical
Isotopes) are readying to bring commercial 67Cu manufacturing on-line over the next 6-12 months using a photonuclear
approach with electron accelerators (Rhodotrons). The availability of 67Cu should reinvigorate interest in 64Cu-based
diagnostics and 67Cu therapeutic development. As the global 67Cu and 64Cu manufacturing footprint expands, the value
of Clarity’s chemistry should increase. Clarity’s IP could control and/or dictate who gets to harness these isotopes,
clinically.
A strategic Pharma angle enabled by copper. Only a few multinationals (Bayer and Novartis) have made significant
investments in the nuclear medicine space, thus far. Other oncology ‘majors’ have been slow to follow for reasons which
may include: a) a pre-occupation with immuno-oncology; b) little/no interest in the diagnostic side of theranostics; c) lack
of validation that radionuclide therapy would confer a survival benefit; and d) complex and unfamiliar supply chain
challenges. Novartis’ work in prostate cancer with PLUVICTO (March ’22 approval) has provided conclusive validation for
the theranostic field. A proprietary position around 64Cu/67Cu pairing has potential value now because the isotopes’ long
half-lives and potential for smaller footprint centralised manufacturing is more ‘Pharma-friendly’, than the esoteric
manufacturing set-ups currently employed by the industry’s ‘workhorse isotopes’ 18F, 68Ga, 131I and 177Lu.
A proof-of-principle exercise with a valuation pay-off. The way to look at Clarity over the next 3 years is as a ‘reduction
to practice’ exercise that validates their proprietary tools and partnerships. The company is progressing several clinical
programs but their intrinsic value may be higher than what may be assessed via future peak sales estimates. Two of
Clarity’s programs are tackling the two cancer indications we might describe as ‘proving grounds’ for theranostics. For
instance, the market for neuroendocrine tumours (NETs) PET agents is a mature one. 64Cu-SARTATE’s development may
serve to ‘show up’ Curium/Radiomedix’s DETECTNETTM product which is also based on 64Cu but suffers from copper
leakage. This is in addition to showing potential superiority to the broadly used 68Ga agent, NETSPOT™. Secondly,
Clarity’s 64Cu/67Cu-SAR-bisPSMA does seem to plug important gaps in prostate cancer diagnosis (left by marketed
products PYLARIFYTM and ILLUCCIXTM). We suspect Clarity’s objective is to invite as much direct comparison as possible
across image quality, depth of diagnostic information and workflow versatility.
The use of copper radioisotopes bypasses the limitations of standard pairings.
1) The half-lives of copper are more suitable for healthcare facility logistics and costs. The long half-life (T½) of
64Cu (T½ = 12.7 hours vs 68Ga T½ = 68 mins or 18F T½ = 109 mins) allows images to be obtained at later time
points ultimately allowing greater flexibility in patient scheduling. Hospitals and independent diagnostic
imaging facilities (IDTFs) are at mercy of patients running late as well as unexpected disruptions to schedules.
With half-lives <2 hours, both 68Ga and 18F based agents may miss their ’window-of-use’ rendering them
wasted doses (as too much radioisotope decay) affecting both the patient and practitioner’s time as well as the
facilities’ bottom line. Copper’s long half-life allows both later stage imaging (i.e. 4-24hr post dose) affecting
imaging precision/clarity but more importantly facilitates practicality in clinical settings with patient delays that
the existing Dx isotopes cannot manage (due to excessive radioactivity decay).
2) The in vivo behaviour of 64Cu and 67Cu should be identical. Positron-emitting 64Cu (Half-life (T ½) = 12.7
hours) as a diagnostic agent perfectly complements 67Cu (T ½ = 61.9 hours) in targeted radiopharmaceutical
diagnosis & therapy. 64Cu will allow precise dosimetry modelling to ensure that 67Cu as a therapy will have the
greatest efficacy – targeting the exact same location as the diagnostic, whilst limiting toxicity. This may also
benefit Clarity in simplifying toxicological testing and streamlining the regulatory review process.
3) Advances in the production of copper ensure unconstrained supply. The majority of established
radiopharmaceuticals (177Lu, 131I) are still produced via nuclear reactors. The recent advances in the production
of 67Cu via electron accelerators has ensured the methods to develop 64Cu and more importantly, 67Cu, in an
economically and logistically feasible manner with unencumbered supply constraints.
Cash runway with partnering and voucher optionality. Clarity closed FY22 with $92.3M in cash. Both Clarity’s 64Cu-
SARTATE diagnostic and 67Cu-SARTATE theranostic have rare paediatric disease designation (RPDD). Both programs
are eligible to receive tradable Priority Review Vouchers (PRV) on FDA approval. The vouchers, if awarded, may be sold
or transferred to other companies. PRVs have been sold for between US$67.5 million and US$350 million, with the
most recent PRV being sold by Marinus Pharmaceuticals to Novo Nordisk for US$110M (July 15th 2022). Clarity’s
strategy has also positioned the company to use its earlier-approved (diagnostic) programs to partly fund their larger,
longer-term theranostic projects.

 1.2 Investment risks
Valuation risk. Clarity is a pre-revenue, biotechnology company without Figure 2: CU6 price history since ASX IPO
an operating business to provide a basis for traditional FCF valuation.
Furthermore, the company is developing clinical assets whose future
economic value is challenging to assess. Our valuation is premised on
forecasts which may not eventuate, creating downside risk to valuation,
akin to other biotechnology companies of this nature making this a
speculative investment thesis.
Clinical risk. Clarity’s success depends on securing positive results from

well-designed clinical trials. Although Clarity’s pre-clinical data looks
supportive of investing in this work, the outcomes of large clinical trials
are difficult to predict. Ambiguous results from trials typically have
dramatic impacts on share price; driven by program delays and the
difficulties associated with accessing development capital. Trial failures
often lead to massive losses in shareholder value, with affected stocks
trading at or below cash backing. Source: Refinitiv.
Intellectual property risk. We summarise the company’s IP in Appendix 6

identifying composition of matter protection for its three key clinical assets (SARTATE, SARbisPSMA and SAR-
Bombesin) out until 2037-40; before considering other forms of non-patent market exclusivity. We assess a range of
ancillary claims protecting chemical synthesis methods, intermediates, formulations and methods of use. Clarity
continues to file new provisional applications. We have not conducted an explicit freedom to operate analysis with
regards to Clarity’s patent portfolio. There is a risk that Clarity’s IP may be circumnavigated which affects their
competitive positioning, and/or that their IP infringes that of others.
Competitive markets risk. Two of Clarity’s asset areas address markets that may be well served by existing and other
investigational products that could be approved sooner. These are in PSMA-positive prostate cancer and neuroendocrine
tumours (NETs). Although Clarity’s products offer putative advantages based on the 64Cu and/or 67Cu isotopes, the
existing supply infrastructure for established isotopes (e.g. 68Ga, 18F, 177Lu) may prove difficult to unseat. Clinical
differentiation may still be key to establishing a niche from which to build broader adoption in saturated markets such as
PSMA-positive prostate cancer and NET diagnosis.
Regulatory risk. The requirement for Clarity to seek and receive regulatory approvals allowing marketing authorisation
for their products carries risk, in that the majority of early stage clinical development programs do not reach marketing
approval phase, and of those that do, only a fraction of applications are successful. The inability for Clarity to receive
positive regulatory feedback and/or approvals presents significant downside risk to this investment.

 1.3 ESG considerations
We do not apply a formal ESG scoring or rating system to companies within our research coverage, however we do
assess and summarise here key factors investors should be made aware of in relation to Clarity Pharmaceuticals’
business operations with respect to Environmental, Social and corporate Governance criteria.
Environmental and Social. There are minimal environmental and social risks associated with Clarity’s core business
activities in our assessment. The company’s products are used by their customers to deliver diagnostic assessments and
subsequent treatments for cancer indications. Clarity’s partnership with NorthStar Medical Isotopes allows access to the
67Cu isotope using non-uranium-based production processes. Regulatory risks associated with the safety and efficacy of
Clarity’s products are ameliorated by the regulatory approval/oversight required by FDA and other regulatory authorities
that guard patient safety and market access.
Governance. We do not assess any critical governance risks in Clarity’s business.
Board independence and power. Per the FY21 annual report (and prelim FY22 report) only 28% of the CU6 board is
considered as independent (2/7). The CU6 Board has formally considered the independence of certain non-executive
directors and self-assessed that their relationships to Clarity do not compromise their ability to bring an independent
judgement to bear on matters. We do note board gender diversity is lacking with only 1 of 7 directors being female,
however note a balanced mix of relevant background experience and viewpoints (medical, pharmaceutical
commercialisation, finance/public markets, corporate governance & chemistry).
Incentives align with shareholder interests. Senior executive remuneration incorporates an appropriate mix of a) fixed
base salary and superannuation contributions; b) short-term cash and/or equity incentives (triggered by clinical, corporate
and operational milestones); and c) long-term incentives granted in equity.

2. Clarity Pharmaceuticals: company overview and background

 Genesis, therapeutic field and objectives
Clarity was born out of University research. Clarity Pharmaceuticals was founded in 2010 by TM Ventures with
$650,000 in seed capital, established to commercialise diagnostic imaging technology developed by the Australian
Nuclear Science and Technology Organisation (ANSTO) and the University of Melbourne (UoM). The technology
employed the use of a copper radioisotope - 64Cu for targeted cancer diagnosis, with later expansion to include 67Cu for
cancer therapy. Clarity has maintained a long-standing collaboration with the UoM through the research of Professor
Paul Donnelly, who led the development of the proprietary sarcophagine (SAR) technology. In early 2021, the UoM
assigned a patent portfolio to Clarity, providing them with the full rights and ownership of the patents moving forward.
This distinguished Clarity as a true ‘off-the-research-benchtop’ company. The company then subsequently listed on the
ASX in August 2021, raising AU$92m.
Clarity’s sarcophagine (SAR) technology was the key to unlocking copper. Historically, the use of copper radioisotopes
was hampered as a result of there being no suitable chelators (cages) that could prevent copper leakage into the body,
limiting their use in medicine. Over multiple iterations, based on research first proposed in 2008, Clarity developed their
innovative, now proprietary, SAR technology - a stable chelator which securely holds copper inside. Using this
technology, researchers at the time, including Professor Paul Donnelly, developed Clarity’s first product – SARTATE, a
product designed to target tumours expressing somatostatin receptor 2 (SSTR2).
Clarity’s portfolio consists of three products – SARTATE, SAR-bisPSMA and SAR-Bombesin all based on core
components. Each of Clarity’s products contain either 64Cu or 67Cu for diagnosis and/or therapy respectively, held in the
SAR platform, that uses a linker to connect to a cancer-specific targeting molecule (Figure 3). The consistency in the core
components of their technology and adopting the use of the same chemical element (as opposed to using different
elements for diagnosis and therapy) has allowed Clarity to expand into multiple indications whilst retaining the same,
superior chemistry backbone.
Figure 3: Clarity’s proprietary SAR technology platform with its four main elements: a radioisotope, cage, linker and targeting ligand
The targeting molecules form the basis for Clarity’s target cancer indications. Clarity has programs in four overall
indications – neuroblastoma (NB) and neuroendocrine tumours (NETs) using SARTATE, prostate cancer using SAR-
bisPSMA and SAR-BBN, and breast cancer using SAR-BBN (Figure 4 overleaf). Given SARTATE was Clarity’s first
established product, SSTR2-expressing cancers – NB and NETs became Clarity’s initial target. Given the lack of available
treatments for NB, the FDA have granted Clarity both orphan drug designation (ODD) and rare paediatric disease
designation (RPDD) for each of their NB programs (in 2020). Clarity are currently pursuing a stand-alone diagnostic for
NETs. Clarity’s prostate cancer programs are split between PSMA-positive and PSMA-negative cancers. Their SAR-
bisPSMA products, akin to recently approved PSMA products (i.e. LOCAMETZ for diagnosis, PLUVICTO for therapy)
target PSMA protein, expressed in 80-90% of prostate cancer cells. SAR-BBN however, targets gastrin releasing
peptide receptor (GRPr)-positive cancers, present in ~75-100% of prostate cancer and ~80% of breast cancer cells.
Clarity have established a broad, but clear strategy. NB presents as Clarity’s most immediate commercial opportunity, as
first-to-market. Their program in NETs and PSMA-positive prostate cancer offer the potential to disrupt already
established markets and prove their technology as superior. SAR-BBN provides the largest opportunity in terms of the
size of the indications and an ability to enter into untouched markets, which will be supported by their earlier projects.

Figure 4: Clarity’s core products and indications
Clarity has a number of clinical trials underway, with multiple readouts expected in the near term. Clarity currently has
six clinical trials in progress or recently completed, with two additional programs expected to commence in the next 6-
12 months (Figure 5). Results from their trials in NB, NETs, and PSMA positive prostate cancer are expected later this
year (2H CY22). We also anticipate a Phase IIb trial in NB for their diagnostic agent to commence in early 2023.
Figure 5: Summary of Clarity’s clinical trial programs
Asset MOA Indication Type Status Exp. completion Clinical trial no.
Phase I/IIa (n=34) CL04

Targets Neuroblastoma Theranostic 4Q CY22
Somatostatin *2/4 cohorts complete NCT04023331
SARTATE
Receptor 2 DISCO
Neuroendocrine
(SSTR2) Diagnostic Phase II (n=63) 3Q CY22
Tumours (NETs) NCT04438304
Phase I (n=30)
Diagnostic PROPELLER
*Recruitment 3Q CY22
(pre-surgery PCa) NCT04839367
Targets Prostate complete
PSMA-positive
SAR- Specific prostate cancer Diagnostic Phase I/II (n=50) COBRA
bisPSMA Membrane 2Q CY23
Antigen (PSMA) (BCR PCa) *50% recruitment NCT05249127
Theranostic SECURE
Phase I/IIa (n=34) 3Q CY26
(mCRPC) NCT04868604
Phase II commencing
Diagnostic N/A N/A
GRPr-positive CY22
prostate cancer
Targets Gastrin Theranostic Planning Phase I N/A N/A
SAR-
Releasing peptide
Bombesin Completed June
receptor (GRPr) Hormone positive C-BOBCAT
2022
(ER+/PR+ and HER2-) Diagnostic Phase I ACTRN12619001
(manuscript
breast cancer 383156
available)
Source: Clarity Pharmaceuticals, clinicaltrials.gov

3. Valuation
 3.1 Risked price target = $0.82 per share
We have used a sum-of-the-parts (SOTP) real options valuation (ROV) approach (Figure 6). We have valued Clarity’s
assets based on their indication, noting that some programs contain both and diagnostic and therapeutic elements
(SARTATE NB, SAR-bisPSMA prostate, SAR-BBN prostate), whilst others are diagnostic only (SARTATE NETs).
Our initiating SOTP valuation comprises:
• Real options analysis of independent commercialisation of SARTATE NB diagnostic, SAR-bisPSMA diagnostic

and SAR-BBN prostate cancer diagnostic products.
• Real options analysis of a partnering licensee model in which Clarity stands to receive milestone and royalty
payments, for SARTATE NB therapy, SARTATE neuroendocrine tumours (NETs) diagnostic, SAR-bisPSMA
therapy, and SAR-BBN prostate cancer therapy.
• Our risked valuation of $0.82 per share is attenuated by certain risk probabilities in relation to clinical trials,
regulatory approvals and market access assumptions. Setting these probabilities to 100% provides an un-
risked estimate of $4.07 per share on a fully diluted basis.
Whilst we have attributed a $0.82 price target, we make note of the three clinical trial outcomes in 1H23 – SARTATE NB
diagnostic and therapy (CL04), SARTATE NETs diagnostic (DISCO) and SAR-bisPSMA diagnostic (PROPELLER)
(outlined in Figure 9) which we assess to have a modest effect on share price. If these events are de-risked (probability
set to 100%), we assess an elevated risked valuation of $0.98 per share (+20%).
At this time, we have not attributed any value to the SAR-BBN breast cancer diagnostic. It is currently difficult to assess
the application of this agent in the breast cancer diagnosis algorithm, particularly as there is no therapeutic program
underway which would likely warrant the use of the product.
Figure 6: SOTP valuation for Clarity Pharmaceuticals

Valuation component Risked valuation (A$M) Comments Unrisked valuation (A$M)
SARTATE Neuroblastoma (NB) 37.5 Diagnostic and theranostic program 154.4
SARTATE Neuroendocrine Tumours (NETs) 32.1 Diagnostic program 133.1
SAR-bisPSMA Prostate Cancer 118.1 Diagnositc and theranostic program 530.5
SAR-Bombesin Prostate Cancer 108.0 Diagnostic and theranostic program 660.5
SAR-Bombesin Breast Cancer - -
Equity value (A$M) 295.8 1,478.5
Equity value per share (A$/share) 0.82 4.07
Price Target 0.82
Source: Wilsons.
Each real options valuation is based on the following constituents and assumptions:
• Four inflection points which include some or all of, a) Phase I/IIa success; b) Phase IIb/III success; c) Partnering
d) FDA approval and market access outcomes (reimbursement and pricing outcomes at least as favourable as
our model assumptions). The expected timings of these inflection milestones and the adjusted valuation are
provided in each of the tables.
• Development costs for each phase of the program. Note, programs for which we anticipate a licensing deal,
we assumed zero specific development costs expecting a partner to sponsor any bridging studies to secure
FDA approval.
• The risked present value which generates our SOTP valuation. We assess the present values on the basis that
trial outcomes, timing and partnering terms are as good or better than our scenario assumptions.
• Equity parameters. We use a common set of assumptions with regard to cost of equity (WACC) that is applied
to our post-tax, free cash flows in order to generate our real-options valuations. We assume a market beta of
1.2 broadly in line with other small-mid biotech under our coverage. Our assumed risk-free rate (3%) and
market risk premium (6%) are consistent across all of Wilsons’ coverage.
We outline individual real options valuations for each program in Appendix 3 (p.50).

Figure 7 outlines the contribution of each program to our SOTP Figure 7: SOTP risked valuation breakdown ($0.82/sh)
valuation.
Whilst we view NB as the most straightforward indication to capture SARTATE Neuroblastoma

(given the current deficiency of targeted diagnosis and therapy), NB is (NB)
$0.10
a rare disorder, with only ~800 incident cases in the US per year.
SARTATE Neuroendocrine $0.30 $0.09
Neuroendocrine tumours (NETs) are also somewhat rare. The Tumours (NETs)
presence of two targeted diagnostics in the market however, is the
main factor driving a lower total value to this program (a conservative
view with upside risk). SAR-bisPSMA Prostate
Cancer
$0.33
Prostate cancer is a significantly larger indication and thus represents
the biggest opportunity for Clarity in the long-term, even with modest SAR-Bombesin Prostate
market share capture. SAR-BBN remains the overall largest revenue Cancer
driver given the unpenetrated market, however remains the most
long-term program. Source: Wilsons.
Figure 9 overleaf outlines the bridge between our risked and unrisked
price targets based on achievement of clinical and development milestones for Clarity across all programs. Note, some
milestones are excluded due to immaterial price target contribution.
 3.2 Valuation sensitivities
In Figure 8 we summarise the results of our sensitivity analyses and scenario modelling around our base case
assumptions for market share, pricing and R&D factors. It must be noted that the largest risk – the risk of clinical trial
failure - is not represented here, noting that subsequent to trial failure, zero value is attributed to the respective program.
We assess the primary drivers to valuation sensitivity are factors affecting peak sales estimates including market share
and pricing. Given we have attributed very modest assumptions to these factors, we assess the sensitivities only from
the point of upside. We assess further sensitivities in R&D expenses and timelines which account for all programs
included in our valuation. In this case we assess both upside and downside scenarios. The two prostate cancer programs
(SAR-bisPSMA, SAR-BBN) are most impactful to valuation.
Figure 8: Drivers of valuation sensitivity
Element Assumption (deviation from base case) ΔPT Revised PT
SAR-bisPSMA SAR-bisPSMA diagnostic global market share and/or therapy US market share
+23% to +39% $1.01 to $1.14
market share increase to 24% (each from a base assumption of 12% peak market share).
SAR-BBN market SAR-BBN diagnostic global market share and/or therapy US market share increase
+6% to +27% $0.87 to $1.04
share to ~65% (from base assumption of ~34% peak market share).
SAR-bisPSMA SAR-bisPSMA US diagnostic and/or therapy product pricing increased by ~30%

+5% to 10% $0.86 to $0.90
pricing (US$3,000 vs US$4,000 and $155,000 vs US$200,000 respectively).
SAR-BBN pricing SAR-BBN therapy product pricing increase by 20% (US$240,000 vs. $200,0000). +6% $0.87
R&D expenses for clinical trials examined at 50% more and 30% less (from base
R&D expenses -10% to +5% $0.74 to $0.86
assumption of $133m for self-funded trials from FY23-FY32)
Clinical trial programs (SARTATE and/or SAR-bisPSMA and/or SAR-BBN) delayed

R&D timelines -20% to -5% $0.65 to $0.78
by 2 years.
Source: Wilsons.
NB and NETs excluded from sensitivities. We have not included sensitivities for the neuroblastoma (NB) or
neuroendocrine (NETs) programs, due to the small indication TAMs whereby a marked change in market share or price
assumptions only contribute ~2-3% in PT change. We also have not included a capital raise risk factor in our sensitivities
at this time. Our future equity capital assumptions, given the market uncertainty and lack of demand for pre-revenue
biotech companies, are kept extremely modest and account for both lower than anticipated raise price and surplus
funding.

13 September 202213 September 2022
Figure 9: Waterfall with de-risking events to our unrisked $4.07 PT
Source: Wilsons.

 3.3 M&A Transactions within the radiopharmaceutical space
China Grand option. Prior to their IPO in 2021, China Grand Pharmaceuticals offered to invest up to $44.7m in Clarity
Pharmaceuticals, dependent on an exclusive license agreement. The agreement would allow China Grand the right to
develop, manufacture and commercialise one or more of Clarity’s pipeline of Targeted Copper Theranostic (TCT)
products in the Greater China region. Under the Deed, Clarity issued 25,543,912 options to China Grand to acquire
shares at an exercise price of A$1.75. Those options lapsed and were cancelled on 25 February 2022 (expiry date).
Clarity will now continue to engage in strategic discussions and will look to enter into the Greater China territory on a
non-exclusive basis. We note that China Grand have executed on a number of radiopharmaceutical licensing and
acquisition deals, including with Sirtex Medical, Telix Pharmaceuticals and ITM Isotope Technologies.
Recent M&A and licensing examples within the radiopharmaceutical space highlight value creation. In considering a
licensing partner for several of their programs (4/7), we anticipate that engagement with Pharma will be established post
successful Phase II studies (or later). In Appendix 5 (p.56) we summarise recent acquisition and licensing deals within the
radiopharmaceutical space. The wide discrepancy in deal values can be reconciled based on the deal type or stage of the
company/asset, noting that mid to late stage companies warrant a significantly larger price tag. Figure 10 below provides
a summary of the value creation in relation to PSMA-617 assets following their eventual acquisition by Novartis. Given a)
the continued popularity of deals in the radiopharmaceuticals market and b) Clarity establishing partnerships at mid-late
stage of their programs, we anticipate Clarity to establish Pharma partnerships with moderately high royalties and
milestones.
Figure 10: Value creation by Endocyte for PSMA-617 assets
Acquirer Company type Target Deal date Deal type Selected deal terms Project(s) included
ABX Biomedizinische Exclusive $12m up front, $3.8m stock & 177
Lu-PSMA-617
Endocyte Public Oct 2017
Forschungsreagenzien license warrants 225
Ac-PSMA-617
177
Lu-PSMA-617
Novartis Public Endocyte Oct 2018 Acquisition $2.1b cash acquisition 225
Ac-PSMA-617
Source: Company data.

4. Forecasts
Clarity’s commercialisation plans are subject to securing regulatory approvals in major markets (USA, EU5). We currently
assess seven products in Clarity’s portfolio. Our revenue and earnings forecasts are predicated on Clarity pursuing a mix
of direct sales and out-licensing models to commercialise these assets. We expect select diagnostic programs to
commercialise via a direct sales model. We assess the remaining programs to undertake a partner out-licensing model
(Figure 11). Under these arrangements a potential licensor (Pharma) would seek exclusive rights to commercialise each
of these products. Clarity would expect to receive upfront fees and other milestone payments linked to licensing
establishment, clinical trial success, regulatory clearances, and cumulative product sales targets. Royalty arrangements
are also customary.
We model the potential economic value of Clarity using these assumptions but appreciate there are a number of
scenarios in which this value could be realised (i.e. either of the aforementioned models, or via an acquisition ahead of
commercialisation phases).
Whilst we model revenue for all seven programs, our focus resides on the four most near-term products (NB, NETs, 2x
prostate), highlighted in Figure 11. The near-term revenue vs. longer term contributions from the programs are
summarised below in Figure 12.
Figure 11: Program timeline overview FY23e-FY30e

Sales model 1H23 2H23 1H24 2H24 1H25 2H25 1H26 2H26 1H27 2H27 1H28 2H28 1H29 2H29 1H30 2H30
Program
Neuroblastoma Dx Direct
Neuroblastoma Tx Partner
Neuroendocrine Dx Partner
SAR-bisPSMA Dx Direct
SAR-bisPSMA Tx Partner
SAR-BBN prostate Dx Direct
SAR-BBN prostate Tx Partner
Phase I-IIb trials

Pivotal trial
Partnering
Approval
First sales
Source: Clarity Pharmaceuticals, Wilsons.
Figure 12: Near-term (FY23e-FY28e) total revenue contribution breakdown (left) and long-term (FY25-FY35e) anticipated revenue (right)
1000
900
800
700
18% SARTATE
600
Neuroblastoma
Revenue (A$m)
($42m)
500
47%
SARTATE NETs 400
($109m)
35% 300
($83m)
SAR-bisPSMA 200
Prostate Cancer
100
0
FY25 FY26 FY27 FY28 FY29 FY30 FY31 FY32 FY33 FY34 FY35
SARTATE Neuroblastoma SARTATE NETs
SAR-bisPSMA Prostate Cancer SAR-Bombesin Prostate Cancer
Source: Wilsons.

 4.1 SARTATE
Clarity is evaluating 64Cu-SARTATE as a diagnostic product in both NB and NETs. 67Cu-SARTATE is then subsequently
being evaluated as a NB therapy. We summarise our forecast assumptions for these two products below.
SARTATE market dynamics. We expect that SARTATE will find its first market in NB diagnostics being used alongside
current SOC (MIBG scan), particularly in non-avid MIBG patients, representing 10-15% of all NB cases. We expect
uptake to quickly extend beyond this cohort, reaching a peak of 35% global market share given the clinical benefits of
using PET over CT scans (image resolution), as well as the logistical advantages, particularly in the length of scanning
time and thus patient flexibility. It must be noted that the value of the diagnostic product is largely as a predicate to NB
therapy. There is minimal revenue generation as a stand-alone product (~$6m peak sales) and we expect market share
will likely be driven by the approval of SARTATE NB therapy. In this regard, we see a peak 35% US market share and
peak sales of $123m in NB therapy, exclusively based on the high-risk cohort, representing ~13% market share in all-
risk patients. We expect penetration to occur quickly (<4 years) due to the lack of currently available treatments.
In the neuroendocrine market, we assess SARTATE as being the third main player to the diagnostics market, reaching
30% global peak market share and US$155m in peak sales. We see potential market share expansion in two ways, a) as
SARTATE is used off-label for non gastroenteropancreatic (GEP) NETs, which has been demonstrated in on-market
products DETECNET and NETSPOT (increasing the addressable population by 30%) and b) if SARTATE proves superior
to DETECTNET (copper-based diagnostic agent currently used) and becomes a ‘next-generation’ replacement of this
product. If SARTATE is successful in NETs diagnosis, we expect their program may expand into NETs therapy, also
completed under a partner model.
Pricing. We assess the US ASP of Clarity’s SARTATE diagnostic programs largely in line with on-market targeted
radiopharmaceuticals (i.e. NETSPOT, PYLARIFY, Figure 13). Clarity’s NB diagnostic candidate is assumed as attaining a
~10% or higher ASP compared to recently approved PSMA diagnostics products, given the orphan drug designation
(ODD) and rare paediatric disease designation (RPDD) status of the product. We estimate EU pricing as a ~60% discount
to US pricing. Our gross to net discount assumption remains at ~10% for diagnostic applications of SARTATE.
Our gross ASP for SARTATE NB therapy $105,000 per dose, modelled as an annual treatment cost of US$420,000 per
patient (4 doses) (Figure 13). We have based our ASP assumptions as an average of the pricing attributed to recently
approved oncology therapies with ODD status (Figure 14). Given that SARATE has both ODD and RPDD designations
for NB therapy, there is potential for significant upside from this assumption. For reference, FDA approved Y-mAb’s
DANYELZA in November 2020 to treat paediatric and adult patients with NB metastases in the bone or bone marrow.
DANYELZA was under an accelerated approval program, having previously been granted an ODD and RPDD, and is
therefore the best predicate for pricing SARTATE. DANYELZA’s typical annual cost is ~US$1,011,882 (2022)1. In its first
year on-market (CY21), DANYELZA generated US$32.9m in sales. Based on this we estimate between 35-50 patients
were treated, representing 12-17% of the new, 2nd line NB patients. We forecast ~25 NB patients to be treated in first
year of 67Cu-SARTATE sales.
Figure 13: Market and pricing assumptions for SARTATE products vs marketed products
SARTATE Diagnostic (64Cu) SARTATE Therapy (67Cu) SARTATE Therapy
SARTATE market assumptions SARTATE NETs SARTATE NB SARTATE NB
Anticipated launch year FY27 FY25 FY27
Peak sales year FY32 FY30 FY31
Peak sales amount (US$) $155m $6m $123
TAM (all pts) 174,607 3,516 3,849
TAM (high-risk pts) N/A N/A 1,471
Patients dosed 52,228 1,248 515
Market share (all pts) 30% 35% 13%
Market share (high-risk pts) N/A N/A 35%
SARTATE pricing assumptions
Price per dose (US$) $3,450 $5,500 Annual treatment price (US$) $420,000
Gross to net discount 10% 10% Gross to net discount 15%
Net price per dose (US$) $3,200 $4,950 Net annual price (US$) $357,000
Pricing of marketed products NETSPOT PYLARIFY DANYELZA
Price per scan (US$) $4,000 $4,900 Annual treatment price (US$) ~$1,000,000
Gross to net discount 10% ~10% Gross to net discount 25%
Net price per dose (US$) (excludes COGS) $3,600 $4,500 Net annual price (US$) $750,000
SARTATE price comparison -10% +10% -55%
Source: Wilsons, AAA, Lantheus, Y-mAbs Therapeutics.
1GoodRx. https://www.goodrx.com/healthcare-access/drug-cost-and-savings/most-expensive-drugs-period

Figure 14: SARTATE therapy pricing presents as a discount to recently FDA approved drugs with ODD status
Drug Year approved Indication US annual incidence (# pts) Annual cost (USD)
Danyelza 2020 Neuroblastoma (bone metastases) ~800 $1,011,882
Kimmtrak 2022 Uveal melanoma ~1,500 $450,000
Fyarro 2021 Perivascular epithelioid cell tumours (PEComa) ~300 $468,000
Breyanzi 2021 Diffuse large B-cell lymphoma ~25,000 $410,300
Avapritinib 2020 Gastrointestinal stromal tumour ~5,000 $384,000
Rozlytrek 2019 NTRK fusion-positive solid tumours ~5,000 $204,560
Kymriah 2017 Acute lymphoblastic leukemia ~6,600 $475,000
Blincyto 2017 B-cell precursor acute lymphoblastic leukemia ~4,900 $754,720
Average $519,808
Estimated annual SARTATE price $420,000
Discount to approved therapy average ~20%
Discount to Danyelza ~55%
Source: FDA, Wilsons.
 4.2 SAR-bisPSMA
Clarity’s 64Cu-SAR-bisPSMA product represents the most near-term prospect in prostate cancer. We therefore
summarise our forecast assumptions exclusively for this product.
PSMA prostate cancer market dynamics. We model global peak net sales of US$136m for SAR-bisPSMA in prostate
cancer diagnosis which assumes 12% share of the market (Figure 15). Our modest share assumptions are based on
Clarity entering the market as the sixth player. Upside in this valuation will likely be due to expansion in the overall TAM
(management, intraoperative use etc.), and, if SAR-bisPSMA is able to demonstrate clear benefits (logistical or clinical) to
already approved products.
Pricing. We assess the US ASP of Clarity’s SAR-bisPSMA diagnostic product as a ≥50% discount to current PSMA
diagnostics. This is a factor of a) entering a crowded market in FY26e and b) levelling out of pricing, particularly as
current products are under transitional pass-through (TPT) payment status which typically lasts 3 years, following which
we would expect prices to be reduced. We see the pricing of SAR-bisPSMA as a means for Clarity to compete and
adequately penetrate the market. Akin to SARTATE, we estimate EU pricing as a ~60% discount to US pricing (Figure
15).
Figure 15: SAR-bisPSMA market and pricing assumptions (US market)

SAR-bisPSMA diagnostic (64Cu)
SAR-bisPSMA market assumptions
Anticipated launch year FY26
Peak sales year FY31
Peak sales amount (US$m) $136m
TAM (no.of scans in initial staging +
521,608
presence of metastatic disease)
Doses administered 64,158
Market share 12%
SAR-bisPSMA pricing assumptions
Price per dose (US$) $3,000
Gross to net discount 10%
Net price per dose (US$) $2,700
Pricing of approved diagnostic products PYLARIFY ILLUCCIX LOCAMETZ
Price per dose (US$) $4,900 $4,900 $5,600
Gross to net discount ~10% ~10% 15%
Net price per dose (US$) (excludes COGS) $4,500 $4,500 $4,760
SARTATE price comparison -60% -60% -45%
Source: Wilsons, Lantheus, Telix Pharmaceuticals, AAA.

Figure 16: Extended forecast snapshot (FY23e-FY32e)

FY23e FY24e FY25e FY26e FY27e FY28e FY29e FY30e FY31e FY32e
Income statement Income s
Revenues Reve
Product sales $m - - 0.2 9.4 85.1 136.6 250.0 327.3 402.3 484.0 P
COGS $m - - (0.0) (1.9) (17.0) (27.3) (50.0) (65.5) (80.5) (96.8) COG
Gross Profit $m - - 0.2 7.5 68.1 109.3 200.0 261.8 321.8 387.2 Gros
Operating Expenses Oper
SG&A $m (7.3) (8.7) (20.7) (21.9) (25.9) (35.7) (58.7) (74.4) (89.7) (106.3) S
R&D $m (23.5) (25.0) (27.7) (38.9) (39.2) (35.7) (39.8) (43.0) (46.4) (50.1) R
D&A $m (0.1) (0.1) (0.1) (0.1) (0.1) (0.1) (0.1) (0.1) (0.1) (0.1) D
EBIT $m (24.0) (26.6) (45.0) (53.3) 3.0 37.9 101.5 144.5 185.8 230.8 EBIT
EBITDA $m (23.9) (26.5) (44.9) (53.3) 3.1 37.9 101.6 144.6 185.9 230.9 EBIT
Profit (Loss) before tax (EBT) $m (23.8) (26.5) (44.8) (53.3) 3.1 37.9 101.7 144.8 186.4 231.7 Profi
Tax (expense)/credit $m - - - (1.7) (2.3) (11.4) (30.5) (43.4) (55.9) (69.5) Tax (
NPAT $m (23.8) (26.5) (44.8) (55.0) 0.8 26.5 71.2 101.4 130.4 162.2 NPA
Cashflow statement Cashflow
Total cash flow from operations $m (25.8) (26.5) (44.8) (51.8) (9.5) 14.8 57.6 81.2 131.7 145.4 Total
Total cash flows from investing activities $m (0.4) (0.4) (0.4) (0.4) (0.4) (0.4) (0.4) (0.4) (0.4) (0.4) Total
Net cash flow from financing activity $m (12.0) (5.0) 65.8 (15.0) (5.0) - - - - - Net c
Cash at End of the period* $m 66.3 39.6 60.3 24.3 14.5 28.9 86.1 166.9 298.3 443.7 Cash
Basic EPS cents (10.0) (11.1) (14.2) (17.4) 0.2 8.4 22.6 32.2 41.4 51.5 Basic EP
Diluted EPS cents (8.5) (9.4) (12.4) (15.2) 0.2 7.3 19.6 27.9 35.9 44.7 Diluted E
v
*Cash includes term deposits.

Source: Wilsons.

 4.3 Investment and expense assumptions
Cash. Clarity had a total of $92.3m in cash and equivalents (includes $62m in term deposits) as at 30 June 2022,
following their August 2021 IPO in which they raised $92m. They are currently running at a cash burn rate of ~$4m per
quarter, noting we expect an uptick in R&D spend and assess ~$10m per HY in the near-term. We assess Clarity are
funded into FY24e.
Balance Sheet. Clarity do not have any debt to service. Their assets include term deposits of $62.0m which we expect
will periodically boost cash-on-hand across FY23-FY27e. We have accounted for a future capital raise of ~$80m in
1H25e which will allow Clarity to fund the remainder of their clinical trial programs. FY26-27e are anticipated to be high
cash burn years given the significant commercialisation and R&D expenses that will be incurred for their prostate cancer
programs.
Expense assumptions include the following:
COGS and gross profit margin. We model Clarity’s COGS based on similar radiopharmaceutical companies (i.e. TLX),
assuming an 80% gross margin. For their diagnostic products, Clarity currently rely on existing CDMOs for the supply of
64Cu. In terms of 67Cu, developments in recent years include establishment of cost-efficient methods of commercial
production. We understand that Clarity currently receives their 67Cu supply from Idaho State University Idaho Accelerator
Center (IAC), which we anticipate will supply sufficient 67Cu for the near-term. There are a number of additional
manufacturers that have begun 67Cu production providing options for Clarity longer-term (e.g. NorthStar). As Clarity’s
pipeline expands, we anticipate large-scale product manufacturing will support gross margins of ~85%, akin to relevant
peers.
R&D expense. We anticipate Clarity’s R&D spend to be relatively high, given the vast number of programs underway
(particularly in the larger indications such as prostate cancer). We expect R&D investment for earlier stage programs
(SAR-bisPSMA therapy and SAR-Bombesin) to be somewhat supported by income received by the products launched
between FY25-FY27e. In addition, Clarity’s anticipated out-licensed products lessen the R&D burden whilst still keeping
future revenue (milestone, royalty revenue) optionality. Clarity currently expense 100% of their R&D with no portion
capitalised. We maintain this R&D treatment moving forward.
SG&A expense. Clarity have had relatively stable G&A expense (~$4M per HY) since 2019, noting an uptick in 1H22 due
to the China Grand Option Deed agreement ($6.8m one-off payment). This payment was in relation to the issuing of
share options to China Grand, which were cancelled on 25th February 2022.
We have accounted for a doubling in headcount in our SG&A expense assumptions from FY23e guided by management
commentary at the FY22 result. We note there has been no sales and marketing expense to date given their lack of
approved drug products. We assume total SG&A expense as 30% of total revenues from FY25e onwards, noting that
sales and marketing expense associated with Clarity’s partnered products are deferred to the potential licensee in our
modelling. Finally, we forecast “Other” income for Clarity, including grant income and R&D tax incentives, which Clarity
have consistently received since FY19. The R&D tax incentive is exclusively based on clinical trials which are conducted
in Australia. We do not forecast any Other income beyond FY24e.
Tax. We forecast Clarity incurring tax expense from 1H26e in our model employing a standard 30% corporate tax rate.
Capex. Clarity is an infrastructure light business with minimal capex requirements. We do not forecast any substantive
capex investments for Clarity over the forecast period.

Appendices

Appendix 1: Characteristics of Clarity’s molecules

 A1.1 Benefits of using 64Cu/67Cu
Clarity Pharmaceuticals are the global leader in the targeted copper theranostic space. Clarity’s approach to targeted
theranostics differs in what is deemed as ‘the perfect pairing’. Traditional targeted theranostics describes the use of
radiopharmaceuticals to diagnose and subsequently treat patients, with 68Ga/177Lu comprising the most common pairing.
Unlike competitors, Clarity employs different isotopes of the same chemical element, copper (Cu), for both the diagnosis
(64Cu) and therapy (67Cu) of various cancers (Figure 17). This provides an important point of difference for Clarity,
particularly regarding the logistics of using radiopharmaceuticals and the clinical outcome for patients.
Figure 17: Clarity employs the use of copper isotopes for both cancer diagnosis and therapy
Established pairings in radiopharmaceuticals present limitations owing to their use of different radionuclides. Diagnostic
PET imaging with the 68Ga isotope emerged as a valuable tool to identify patients suitable for Peptide Radionuclide
Therapy (PRRT) with 177Lu, with the first approval of a diagnostic with a subsequent therapy companion granted in
neuroendocrine tumours (NETs); NETSPOT™ diagnostic and LUTATHERA™ therapy. The safety and efficacy of PRRT
relies on selectively delivering the highest possible dose of radiation to the tumor while sparing organs from unnecessary
radiation toxicity, particularly the kidney. Accurate prospective dosimetry with a diagnostic allows prescription of a
therapeutic PRRT dose that maximizes efficacy within the tolerance of organs such as the kidney. Essentially, PRRT is
reliant on the accuracy of the diagnostic. The use of a short-lived radionuclide 68Ga (half-life = 68 mins) to predict
dosimetry for subsequent therapy with the long-lived radionuclide 177Lu (half-life = 6.5 days) introduces limitations in
this modeling dosimetry2. Furthermore, the use of two different chemical elements (Gallium and Lutetium) with differing
chemistries can lead to inconsistent tissue biodistribution, as it is likely that the complex formed with the different
elements do not have the same binding and tumour internalisation. This is in addition to the likely differences in varying
metabolism and excretion pathways3. The use of the same element for both imaging and therapy represents an
important advance for radionuclide therapy, particularly if the half-life of the diagnostic agent is sufficient to evaluate
clearance kinetics from critical target organs.
Logistical issues remain with currently used radioisotopes. Commonly used diagnostic radioisotopes in prostate cancer
such as 68Ga and 18F exhibit short half-lives (68 mins and 110 mins respectively) which can create logistical issues,
particularly in areas without established facilities and/or remote locations (particularly relevant given 80% of prostate
cancer patients are seen in these lower-level community settings). This additionally constrains patient scheduling,
whereby appointments are often scheduled in the afternoon to allow time in the morning for dose preparation and
dispatch. Channel checks within the PSMA-diagnostic industry suggest that these issues are not currently pressing, with
the on-time in-full (OTIF) percentage (a metric to describe the rate at which hospitals/clinics receive the product on time
and in full) sitting at 97-98%. This however may change as demand and market penetration continue to increase.
Similarly, the rapid increase in the use of 177Lu for therapeutic application, which can only be produced via a nuclear
reactor, may present further supply issues in the near future. Whilst there has been a marked increase in the supply of
Lutetium in the last 10 years, the capital-intensive nature of establishing a nuclear reactor facility (~AU$600m4) has
hindered supply matching the rapid demand. We note the recent halt to distribution of Novartis’ PLUVICTO™ and
LUTATHERA™ as a relevant case in point.
2Eder et al. (2012). 68Ga-complex lipophilicity and the targeting property of a urea-based PSMA inhibitor for PET imaging. Bioconjugate chemistry, 23(4), 688-697.
3 Afshar-Oromieh et al. (2013). PET imaging with a [68Ga] gallium-labelled PSMA ligand for the diagnosis of prostate cancer: biodistribution in humans and first evaluation of
tumour lesions. vol. 40. Eur J Nucl Med Mol Imaging, 486-495.
4World Nuclear Association. (2017). Australian Research Reactors and Synchrotron. https://www.world-nuclear.org/information-library/country-profiles/countries-a-
f/appendices/australian-research-reactors.aspx

Positron energy of radioisotopes determine the quality of the scan. Beside half-life, the positron energy also determines
the utility of the radioisotopes in preclinical and clinical settings. Radioisotopes such as 68 Ga and 124 I with relatively large
positron energy (average positron energy of 830 and 819 kEV respectively) yield considerably lower resolution,
especially when using microPET (small animal PET) imaging in preclinical settings and in identifying smaller tumours in
humans. For these purposes, radioisotopes such as 18F and 64Cu with moderate positron range (average positron energy
of 250 and 288 respectively) are more desirable.
A summary of isotope characteristics and their clinical and logistical effects are summarized in Figure 18.
Figure 18: Comparison of diagnostic and theranostic radioisotope characteristics
Diagnostic PET radioisotopes
Type Half-life (T½) Avg. positron Energy (keV) Primary production method
64Cu 12.7 hours 288 Cyclotron
68Ga 68 mins 830 Generator
18F 110 mins 250 Cyclotron
89Zr 78.4 hours 396 Cyclotron
What does
• Tumour delineation • Image resolution • Cost
this affect? • Logistics/patient scheduling • Safe radiation exposure • Availability
• Radiation exposure
Ideal range/ • +6 hours to allow flexibility in imaging. • 18F well documented to have better • Cyclotrons preferred due to lower
method • <3 days to limit toxicity. resolution than 68Ga due to lower energy cost.
Therapeutic radioisotopes
Type Half-life (T½) Range in tissue (mm) Primary production method

67Cu 2.6 days 0.7 Electron Accelerator
177Lu 6.7 days 0.7 Nuclear Reactor
90Y 2.7 days 3.4 Nuclear Reactor
225Ac 10 days <0.1 Electron Accelerator
What does
• Critical dosage levels to allow effective therapy • Specificity of effect • Cost
this affect? • Frequency of dosing • Off-target effects • Availability
• Choice of targeting agents & suitable Dx agent for dosimetry
• Nuclear reactors are expensive and
• T ½ of 6hrs-7 days to allow therapeutic effect • Larger ranges may target non-cancerous produce harmful waste. Majority in
Ideal range/
• Shorter T ½ <3 days may allow more frequent dosing cells; may be better for large tumours the market are also >40 years old.
method • Electron accelerators are currently
• 68Ga/177Lu dosimetry is inaccurate; 64Cu/67Cu ideal. • The smaller the range the more specificity
less available
Source: Sgouros et al.5, Holik et al.6 Gudkov et al.7.
5Sgouros et al. (2020). Radiopharmaceutical therapy in cancer: clinical advances and challenges. Nature Reviews Drug Discovery, 19(9), 589-608.
6Holiket al. (2022). The Chemical Scaffold of Theranostic Radiopharmaceuticals: Radionuclide, Bifunctional Chelator, and Pharmacokinetics Modifying Linker. Molecules,
27(10), 3062.
7Gudkov et al. (2015). Targeted radionuclide therapy of human tumors. International Journal of Molecular Sciences, 17(1), 33.

 A1.2 Clarity’s three focus ligands under development
A1.2.1 SARTATE
SARTATE was the first product developed by Clarity. SARTATE™ combines the somatostatin analogue octreotate,
which targets SSTR2-positive lesions, with Clarity’s proprietary SAR Technology and the isotopes of copper. The human
hormone somatostatin is released by neuroendocrine cells of the gastrointestinal (GI) tract and has an inhibitory effect on
bowel motility, GI secretion, and absorption of nutrients. The physiological actions of somatostatin are mediated through
5 receptors (SSTR1 to 5) with research indicating that SSTR2 is highly expressed at the cell surface of human cancers
including neuroblastomas and neuroendocrine tumours (NETs).
SARTATE is based on a well-established approach with improved chemistry. Peptide Receptor Radionuclide Therapy
(PRRT) is well established particularly in NETs with the use of AAA’s NETSPOTTM (imaging) and LUTATHERATM
(therapy). Both contain DOTA-octreotate (DOTATATE), a peptide with a bonded chelator, but use different radionuclides
for imaging, gallium-68 (68Ga), and therapy, lutetium-177 (177Lu).
SARTATE has 3 basic components, either 64Cu (for imaging of NB or NETs) or 67Cu (for treatment of NB) linked via
MeCOSar (a bifunctional copper chelator) to octreotate - a somatostatin analogue that targets SSTR2. The main benefits
of SARTATE in comparison to other copper-based radiopharmaceuticals is the development of the sarcophagine chelator
which ensures no leakage of copper – an issue that has been documented with the clinical use of Curium’s
DETECTNETTM, an on-market diagnostic PET agent for NETs, where liver toxicity has been noted as a side effect of the
agent8.
A1.2.2 SAR-bisPSMA
Entering into the PSMA market with copper. SAR-bisPSMA is being developed for the diagnosis, staging and
subsequent treatment of cancers that express Prostate Specific Membrane Antigen (PSMA). PSMA is a protein
expressed in 80-90% of prostate cancer cells. The expression of PSMA increases with tumour aggressiveness,
metastatic disease, and recurrence. The application of PSMA as a target in the diagnosis and therapy of prostate cancer
is well established, with FDA-approved products now in place (ILLUCCIXTM, PYLARIFYTM, LOCAMETZTM for diagnosis
and PLUVICTOTM for therapy). Clarity is investigating SAR-bisPSMA both as a stand-alone diagnostic product in patients
with confirmed or biochemical recurrent prostate cancer, as well as a therapeutic product in metastatic castrate resistant
prostate cancer.
Copper provides a dual-binding motif enhancing binding affinity and PSMA-specific internalization. In contrast to other
PSMA-targeting products (such as PSMA-11), SAR-bisPSMA connects two PSMA binding motifs via the use of Clarity’s
SAR chelator technology instead of one, allowing the identical molecule to be used for diagnostic (via 64Cu) and
therapeutic applications (via 67Cu). The increased tumour retention of SAR-bisPSMA is attributed to multivalent
interactions provided by the presence of the two binding motifs.
SAR-bisPSMA is made up of either 64Cu or 67Cu linked via MeCOSar (a bifunctional copper chelator) to two lysine-
ureido-glutamate functional groups (one on each side), each of which are attached to a PSMA-binding motif.
A1.2.3 SAR-Bombesin
SAR-Bombesin provides expansion into uncaptured radiopharmaceutical markets. SAR-Bombesin (SAR-BBN)

specifically targets cancer cells that express gastrin releasing peptide receptor (GRPr). GRPr is reported to be expressed
in many cancers including those from the breast, prostate, uterus, gastrointestinal tumours, lung (small and non-small
cell) and in gliomas. Research has demonstrated low GRPr expression in healthy cells, making GRPr a potential ideal
candidate in targeted diagnosis and therapy. Bombesin is a tetra-decapeptide with high binding affinity to GRPR, and its
uptake, mainly in breast cancer, has been demonstrated in human trials.
Clarity’s SAR-BBN will focus on prostate and breast cancer. Clarity is initially developing SAR-BBN as a theranostic for
breast cancer and prostate cancer. GRPr was shown to be expressed in 83% of estrogen receptor (ER) positive (Luminal
A i.e. the most common form) breast cancers and in 75-100% of prostate cancers.
SAR-BBN is made up of either 64Cu or 67Cu linked via MeCOSar (a bifunctional copper chelator) to a GRPR antagonist.
8Pfeifer. et al. (2012) Clinical PET of neuroendocrine tumors using 64CuDOTATATE: first-in-humans study. J. Nucl. Med. 53, 207–1215

Appendix 2: Clinical overview and competitive positioning

 A2.1 Neuroendocrine tumours (NETs)
A2.1.1 Disease overview

Figure 19: NETs are typically divided by the site of
Incidence and prevalence. Neuroendocrine tumours (NETs) are most commonly located in origin, be it foregut, midgut or hindgut.
gasteroenteropancreatic (GEP) sites (e.g. small intestine, colorectum stomach) with tumours
also residing in the lungs and less commonly from unknown primary sites (Figure 19). The
incidence of NETs is approximately 3 patients per 100,000 in the USA (2015)10 with an
annual incidence rate increase of 8.4% in males (2001-2015 data). This represents
approximately 175,000 patients with active disease in the US at present, with 12,000 new
NETs diagnoses per year11. The rising incidence in NETs has been demonstrated from
longitudinal data across all 50 US states and presents a worrying trend (USCS database).
Albeit, improvements in compliance and surveillance colonoscopies are likely contributors
to this rising rate. Incidence rates are disproportionately higher in Black (5.5 per 100,000)
populations versus White (3.4 per 100,000), American Indian and Asian/Pacific islander
populations (2.3 per 100,000 respectively).
A2.1.2 Current standard of care
Surgery used to manage ~30% of cases, however is typically not curative. Surgical
resection is the first line therapy for management of NETs. However, given the
Source: Oronsky et al9.
asymptomatic nature of NETs, they can often be metastatic (have spread to other parts of
the body) by the time of diagnosis. Hence it is estimated 30-40% of NETs are localized and
successfully treated with surgery alone whilst the remaining 60-70% (that are metastatic) require additional therapy
including chemotherapy, targeted drug therapy (including somatostatin analogues or SSAs), radiation therapy, tyrosine
kinase inhibitors (TKIs) and peptide receptor radionucleotide therapy (PRRT) (e.g. LUTATHERA). SSAs are a typical first
line port of call if surgery is not an option, depending on the aggressiveness of the cancer which could mandate
immediate chemotherapy. The strategy for management following progression of SSAs leads to the use of LUTATHERA
in these progressing patients.
Somatostatin receptor status of tumours required to determine course of care. NETs are known to secrete abnormally
high levels of hormones owing to dysregulation of the neuroendocrine system. Molecular imaging of NETs is standard of
care to aid clinicians in deciding on the course of care based on information around the expression profile of the tumours
(including somatostatin receptor status), their primary location and degree of spread within the body (i.e. staging of the
tumour, metastases etc.). Approximately 80% of NETs are thought to be somatostatin receptor positive in nature12. The
use of somatostatin PET tracers (summarised in Figure 21) has become standard of care within NETs management and
guides clinicians as to treatment outcomes, including their use of targeted radiotherapy Figure 20: Quarterly sales of NETs products (Dx, Tx) from
with LUTATHERA. The three approved SSR-PET agents in Figure 21 are all included in Novartis/AAA
the latest NCCN guidelines as relevant options for tumour evaluation13.
AAA’s NETSPOT (68Ga-DOTATATE) continues to be the dominant PET agent in NETs

management. We understand that NETSPOT is at present still the dominant PET agent
for determination of somatostatin positive tumours within NETs patients, however since
the addition of competitor product DETECTNET to the NCCN guidelines (May 2021)
NETSPOT has seen market share losses/absence of growth.
Initially, following NETSPOT’s approval in 2016, its image clarity vs prior agents and its
current ease of development and access (via AAA/Novartis’ distribution networks) led it
to become SOC. The main difference between the previously used 68Ga-DOTATOC is
the affinity to the different SSTR subtypes. While the ligand octreotide used for
DOTATOC targets the SSTR subtypes 2, 3, and 5, octreotate used for DOTATATE has
an enhanced affinity for the SSTR subtype 2. Figure 20 shows the current quarterly
sales of AAA/Novartis assets LUTATHERA (treatment) and NETSPOT (known as
SomaKit in Europe). The NETs indication has supported a ~US$200m annualized global Note: Sandostatin is not exclusively used for the management of NETs
sales market for NETSPOT. Sandostatin therapy for NETs annualizes >US$800m annual and therefore totals here represent uses in other approved indications,
sales highlighting the potential for effective therapies in this indication. namely Acromegaly.
Source: Novartis, AAA.
9 Oronsky et al. 2017. Nothing but NET: A Review of Endocrine Tumours and Carcinomas. Neoplasia. 19(12): 991-1002.
10 Patel et al. 2019. Incidence of Neuroendocrine Tumors in the United States from 2001-2015: A United States Cancer Statistics Analysis of 50 States. Cureus. 26: 11(3):
e4322. https://pubmed.ncbi.nlm.nih.gov/31183301/.
11 Dasari et al. 2017. Trends in the incidence, prevalence and Survival outcomes in patients with Neuroendocrine Tumours in the United States. JAMA Oncol. 3(10): 1335-
1342.
12 SNMMI.org. Neuroendocrine Tumours – Disease condition homepage & Fact Sheet. Accessed online June 2022.
13 Shah M et al. 2021. Neuroendocrine and Adrenal Tumours. Version 2.2021. NCCN Clinical Practice Guidelines in Oncology. 19(7): https://doi.org/10.6004/jnccn.2021.0032

Curium’s DETECTNET became the first approved copper diagnostic product in 2020. DETECTNET (64Cu-DOTATATE)
was FDA approved in 2020, also for the detection of NETs, however market uptake was marred by COVID and did not
replicate the rapid uptake of NETSPOT (in 2017). We do note however, in April 202214, Curium announced a 50%
increase in DETECTNET production capacity citing an overwhelming response to the product. This demand is thought to
be related to several factors including; a) an overall demand for NETs diagnostics; b) 68Ga shortages making
competitor’s NETSPOT availability more limited, and c) an interest in the copper-based product specifically given the
image superiority and ability to detect more small lesions. Industry feedback does suggest that there continues to be an
education piece that is ongoing with regards to copper-based products and the availability of DETECTNET in the market.
NCCN guideline inclusion in May 2021 has boosted awareness within the oncology community however it is understood
that at present DETECTNET remains a product largely used in academic and metro hospital centres/clinics with more
regional community centres not aware of its existence/not able to access it – hence maintaining some of NETSPOT’s
dominance.
Adoption of DETECTNET on clinical grounds is good – awareness still a challenge. Anecdotal feedback from oncologists
suggests that DETECTNET is a clinically better choice particularly when a clinician wants to have improved visibility on
small metastatic lesions which better informs them as to their patient’s status. In many cases however the
prescribing/referring clinician (typically a medical oncologist) does not specify the specific product they wish to use and
may simply note they want an SSTR2 scan which leaves the choice of product/isotope up to the nuclear medicine
department. This real-world workflow highlights the importance of clinical education build out in the
radiopharmaceutical space (including NETs), as it appears when clinicians know about the benefits of copper and have
access to it they preference the DETECTNET product. This will be a key challenge for Clarity in the future, however
Curium may be doing much of the groundwork for them.
Current PET agents used off-label in non-GEP NETs, and used frequently. Both NETSPOT and DETECTNET cite on their
labels they are for use in GEP-NETs (comprising 70-80% of all NETs). Clinician feedback suggests broader label use of
these PET agents for all NETs cases – which expands the potential serviceable market by 20-30% (vs our assumptions).
Further to this, it is understood that the clinicians that routinely use either NETSPOT or DETECTNET are doing so on a
regular basis (i.e. 2-4 scans per year per patient). This duplication of scans is used for diagnosis and staging as well as
treatment monitoring and management of recurrence.
DETECTNET has the same logistical benefits posed by SARTATE but suffers from copper leakage. The main benefits of
DETECTNET in direct comparison to its 68Ga-based counterpart, NETSPOT, is akin to SARTATE - the flexibility in
logistics and patient scheduling owing to the longer half-life of copper. Comparing data from 64Cu-DOTATATE to 68Ga-
DOTATOC, the detection rate of true lesions was higher for 64Cu-DOTATATE, but the tumor to background ratio was
similar for both radioisotopes. It must be noted that radiation exposure was ~2x for 64Cu-DOTATATE compared with
68Ga-DOTATOC. The trade-off between enhanced imaging characteristics and increased radiation exposure must be
considered. To date, it seems no reports exists where imaging with 64Cu-DOTATATE instead of 68Ga-DOTATOC led to a
change in management in NETs patients. This is most probably due to the fact that the detection of an additional liver
metastasis in a patient with extensive disease is less relevant in daily practice than in imaging studies. The FDA
approved 64Cu-DOTATATE (DETECTNET) for staging SSTR-positive NETs in 2020 however its approval in Europe is
currently pending. Figure 21 overleaf compares the characteristics of the Clarity’s potential 64Cu-SARTATE to the
original imaging agent, 68Ga-DOTATOC, as well as to the subsequently approved, 68Ga-DOTATATE (NETSPOT) and
64Cu-DOTATATE (DETECTNET). The most important factors to note are highlighted in Figure 21. The increased liver
SUVmax demonstrated by DETECTNET is indicative of the copper leakage as a result of the DOTATATE chelator. We
also highlight the SSTR subtype. Whilst we could not source the binding affinity of each agent, the three newer agents
all use ocreotate to target SSTR2 and are therefore assumed as demonstrating similar, if not the equivalent, receptor
binding affinity.
Only approved NETs radionuclide (PRRT) therapy is label agnostic as to diagnostic used. AAA’s LUTATHERA (177Lu-
DOTATATE) is approved (2018) for the treatment of gastroenteropancreatic (GEP) NETs that are somatostatin receptor
positive. The ERASMUS Phase II study, which formed the basis for LUTATHERA’s FDA approval, utilized Octreoscan^
(111In-pentetreotide) for determination of somatostatin receptor positive NETs prior to trial inclusion and subsequent
LUTATHERA treatment. The approved LUTATHERA label however does not stipulate a specific companion diagnostic
however and allows use of any diagnostic to determine the somatostatin-positive nature of the NETs. LUTATHERA
continues to be the only currently FDA approved therapy for NETs.
^NOTE: Octreoscan (Mallinckrodt Pharmaceuticals) was a precursor approved PET agent prior to the 2016 approval of
NETSPOT (68Ga-DOTATATE) which is now the more typical standard of care PET scan used for NETs diagnosis.
NETSPOT compared to Octreoscan has improved sensitivity (96% vs 72%) and accuracy (94% vs 82%) by virtue of a
higher negative predictive value (NPV) (93% vs 65%)15 which has driven its clinical adoption and use.
14 https://www.curiumpharma.com/2022/04/19/curium-announces-significant-increase-in-detectnet-copper-cu-64-dotatate-injection-production-
capacity/#:~:text=(St.,week%20of%20May%201%2C%202022.
15 DMS Health Technologies, The Clinical Impact of Utilising NETSPOT. Accessed online: https://www.dmshealth.com/09/the-clinical-impact-of-utilizing-netspot/

Figure 21: Head to Head comparison of approved SSTR2 PET/CT agents for NETs versus Clarity’s 64Cu-SARTATE
PET Agent 68Ga-DOTATOC 68Ga-DOTATATE 64Cu-DOTATATE 64Cu-SARTATE
EMA approval 2016 2016 not approved not approved
FDA approval 2019 2019 2020 not approved
Manufacturer UIHC, AAA AAA (Novartis) Curium/RadioMedix Clarity
Trade name 68Ga-DOTATOC NETSPOT/SomaKit DETECTNET™ -
Half-life 68 minutes 68 minutes 12.7 hours 12.7 hours
Imaging window within 1h post dose within 1h post dose 1-3 h post dose 1-20 h post dose
Effective imaging
148 MBq 200 MBq 148 MBq 200 MBq
dose
Mean SUVmax 20.4 (±14.7) 23.61 (±10.8) 36.9 (±5.6) 33.3 (±9.9)
Lesion SUVmax 39.0 (±8.6) 31.7 (±9.6) 41.5 (±8.6) 41.9 (±8.6)
Liver SUVmax 7.7 (±1.4) 7.1 (±0.8) 9.6 (±0.5) 5.9 (±2.2)
Sensitivity 95% 97% 91% N/A
Specificity 87% 95% 97% N/A
PPV 91.0% 98.0% 96.7% N/A
NPV 92.0% 90.4% 100% N/A
Accuracy 91.4% 96.6% 98.4% N/A
SSTR subtype SSTR2 & SSTR5 SSTR2 SSTR2 SSTR2

Phase II currently
Trial (latest stage) Phase III Phase III Phase III
enrolling
Trial identifier NCT04552847 NCT01578239 NCT03673943 NCT04438304
Somatostatin positive
Label indication SSR2 positive NETs SSR2 positive NETs NA
NETs
Population Adult & paediatric Adult & paediatric Adult only NA
Source: Poeppel et al.16, Johnbeck et al.17 Wilsons.
Clarity’s ongoing Phase II DISCO study focuses on head to head with NETSPOT, not DETECTNET. Clarity are currently
recruiting their open label Phase II DISCO trial (NCT04438304) which will seek to enroll up to 63 patients from
Australian sites with confirmed or suspected NETs. The primary outcome measures focus on diagnostic performance of
64Cu-SARTATE vs NETSPOT at 4- and 20hrs post PET agent administration. The trial is restricted to patients ≥ 18 years
of age. It is understood this trial hopes to show the superior diagnostic efficacy of Clarity’s agent over the SOC NETSPOT
agent with improved imaging window flexibility (4-20hr). We do question whether the omission of the standard 1hr
post-dose window is wise given this is most logistically relevant to how NETSPOT is used in clinic, and may ultimately
be how SARTATE is used for each of clinical management, but appreciate the focus is on image superiority in this study.
First in-human trials of 64Cu SARTATE was demonstrated in NETs. In a clinical trial of 10 patients, Hicks and colleagues
aimed to assess, as a primary endpoint, the safety profile of 64Cu SARTATE and, as a secondary endpoint, its diagnostic
performance compared to 68Ga-DOTATATE in NET patients. The criteria included ≥18 years old, life expectancy ≥8
weeks, biopsy-proven NET, and at least 1 site of SSTR2-expressing lesion (assessed through 68Ga -DOTATATE aka
NETSPOT). PET/CT was performed after 30 min, 1 h, 4 h and 24 h after 64Cu SARTATE/68Ga -DOTATATE injection. No
significant adverse reactions were registered, except for mild infusion-related events in three subjects. Of note, 64Cu
SARTATE showed intense accumulation in tumor lesions at each time point of acquisition, with comparable or superior
detection rates (i.e., number of lesions detected) with respect to 68Ga -DOTATATE, especially in the liver. Figure 22
overleaf, illustrates the diagnostic performance of 64Cu SARTATE with respect to 68Ga -DOTATATE in NET metastatic
patients. These preliminary results, although limited by the small cohort of patients and specifically referring to an adult
population, encouraged further studies to better define the role of 64Cu SARTATE in neuroblastoma, especially with
regards to the possibility of utilizing PET/CT for personalized provisional dosimetry before PRRT with 67Cu SARTATE,
owing to the prolonged half-life of the diagnostic radioisotope allowing clinicians to perform PET/CT at different time
points, thus determining the in vivo estimation of SARTATE’s biodistribution and clearance.
16Poeppel et al. (2011). 68Ga-DOTATOC versus 68Ga-DOTATATE PET/CT in functional imaging of neuroendocrine tumors. Journal of nuclear medicine, 52(12), 1864-1870.
17Johnbeck et al. (2017). Head-to-head comparison of 64Cu-DOTATATE and 68Ga-DOTATOC PET/CT: a prospective study of 59 patients with neuroendocrine tumors.
Journal of Nuclear Medicine, 58(3), 451-457.

64Cu-SARTATE may plug the gaps of its competitors. The chelator employed by the DETECTNET product, DOTATATE,
when combined with copper is unstable and allows copper to dissociate from its “grip” and leak into the body. This
causes issues for two reasons, a) 64Cu2+ dissociation from the chelator causes copper build-up in the liver, creating a
dose-limiting factor18 and b) the copper dissociation somewhat removes the benefits of using copper in the first place, in
that the reduced activity due to copper leakage does not allow imaging at later time points (which can be crucial to
detect additional tumours). Whilst it is yet to be determined whether these enhanced imaging benefits will play a major
part in product uptake, the innovative SAR technology employed by Clarity holding the copper in a stable form, does by
pass these existing issues.
Figure 22: Visual comparison of DETECTNET (64Cu-DOTATATE) and Clarity’s 64Cu-SARTATE PET agent in NET detection
A2.1.3 Market dynamics
Market players and TAM. Advanced Accelerator Applications (AAA) (acquired by Novartis) dominate the NETs field with
their NETSPOT diagnostic and LUTATHERA therapy. French radiopharmaceutical and distribution player Curium are also
active in this market with their recently approved copper-based DETECTNET PET agent. Aside from these companies,
the radiopharmaceutical field and manufacture of older NET PET agents is managed disparately by academic institutions
or radiopharmacies. With Curium being a private company, visibility as to the revenues generated from DETECTNET
sales since its 2020 launch are not readily available and therefore accurately assessing relative market share within the
approved NET PET agents is challenging. Based on NETSPOT pricing (US$3,200) and revenue generation (US$200m)
as reported by Novartis, we estimate NETSPOT to be 45% penetrated across the total NETs population (as opposed to
GEP-NETs exclusively). This is based on a pool of 132,000 NETs patients per year, of which ~20,000 are new cases. We
assess that the remaining 55% is shared between DETECTNET as well as older NET PET agents and alternative forms
of imaging (FDG). DETECTNET has had a slow commercial start but appears to be quickly growing as the second place-
holder which could take #1 position in time as awareness/availability of the product grows. We expect that Europe are
slower in uptake of the ready-to-use kits (NETSPOT/SomaKit), with a larger reliance remaining on 68Ga-DOTATOC,
however it appears the ease of use and access has begun to ramp up demand19.
AAA has the power of the pair in marketing. The ability for AAA to co-market their NETSPOT and LUTATHERA products
to win over market share is powerful from a clinician uptake perspective, with many associating the two products and
using them in concert (despite their being superior diagnostic options that pair with LUTATHERA). The strength of the
combined marketing narrative cannot be overstated. There is also the optionality for bundling in terms of price, which
AAA have not done yet however is a competitive option for them to defend against new PET entrants. For reference,
LUTATHERA currently shares the treatment of NETs largely with Sandostatin as well as other therapies (chemotherapy,
TKIs etc). Sandostatin (Novartis), also known as octreotide, is a synthetic somatostatin analogue that is used for the
management of NETs (in addition to another rare disorder – Acromegaly), with its quarterly sales also represented in
Figure 20. Its use continues to be a dominant treatment option even following the 2018 approval of LUTATHERA.
Octreotide is still used to manage tumour growth with a key Phase III trial (PROMID) showing survival benefits20 when
given monthly, which supported its inclusion in treatment guidelines for patients with midgut NETs21. Sandostatin came
off patent in early 2017. To note, one of the two trials that supported LUTATHERA’s FDA approval (NETTER-1 trial)
used LUTATHERA in combination with standard of care octreotide vs octreotide alone which showed a superior
progression-free survival (PFS) benefit of the combination in metastatic patients that failed to respond to first line SSA
therapy22.
18Pfeiferet al. (2012). Clinical PET of neuroendocrine tumors using 64Cu-DOTATATE: first-in-humans study. Journal of Nuclear Medicine, 53(8), 1207-1215.
19Hennrich & Benešová. (2020). [68Ga]Ga-DOTA-TOC: The First FDA-Approved 68Ga-Radiopharmaceutical for PET Imaging. Pharmaceuticals (Basel, Switzerland), 13(3), 38.
https://doi.org/10.3390/ph13030038
20 Rinke A et al. 2009. Placebo-controlled, double-blind, prospective, randomised study of the effect of octreotide LAR in the control of tumour growth in patients with
metastatic neuroendocrine midgut tumours: a report from the PROMID study group. J Clin Oncol. 27 (28): 4656-4663.
21 Costa F & Gumz B. 2014. Octreotide – A Review of its Use in Treating Neuroendocrine Tumours. Eur Endocrinol. 10(1): 70-74.
22 Strosberg G et al. 2017. Phase 3 Trial of 177Lu-DOTATATE for Midgut Neuroendocrine Tumours. N Engl J Med. 376(2): 125-135.

New threats to PET imaging more broadly coming in the form of blood analysis. We note the development of other
diagnostics such as ctDNA – a blood-based analysis of circulating tumour DNA that may be used to monitor treatment
progress as well as absence of tumour recurrence. ctDNA has quickly become more routine in patient management
however, is still a new, developing technology. It is feasible to see new technologists like ctDNA replacing the need for
as frequent duplicate PET imaging in the future, with a hybrid approach of both imaging and ctDNA being used across
the spectrum of care for both cost and convenience reasons – key drivers of healthcare practice.
A companion therapy could help drive diagnostic product uptake. Understanding the current market landscape and gaps
is key for Clarity. If Clarity are able to demonstrate success of SARTATE as a diagnostic, we expect that (with their
Pharma partner) they may look to develop an accompanying SARTATE therapy which would compete against
incumbents (octreotide and/or LUTATHERA) which have somewhat limited uptake/success in NETs owing in part to
clinical efficacy but also administration challenges (i.e. with LUTATHERA requiring 4-5hr infusion sessions). The ability
to market a true theranostic pair is also powerful for clinician buy in. Further, Novartis recently announced (May 22) a halt
in production of their 177Lu-based therapies (LUTATHERA, PLUVICTO) owing to supply issues, shortly after new product
launch, which has now resumed (end June 22) albeit does not seem to be completely solved for. Expecting this to be an
ongoing issue in the foreseeable future, this could disrupt the strength to AAA’s offering and open up a more accessible
opportunity for the likes of Clarity to enter the market, in addition to potential dosing benefits (vs long LUTATHERA
infusions) and potential for superior clinical efficacy – the major driver to all clinical adoption.

 A2.2 Neuroblastoma (NB)
A2.2.1 Disease overview Figure 23: Primary and secondary sites of

neuroblastoma
Incidence and prevalence. Neuroblastoma (NB) is a cancer that develops from immature nerve cells
found in several areas of the body. It most commonly arises in and around the adrenal glands (a
gland that sits atop the kidneys) (Figure 23). It accounts for ~8% of all childhood malignancies and is
the most common solid tumour in children not arising from the brain. The median age at diagnosis is
18 months, with 90% of all NB cases presenting in children under the age of five23. The incidence
rate in the United States sits at ~800 cases per year24, allowing Clarity to receive two Orphan Drug
Designations (ODD) and two Rare Paediatric Disease Designations (RPDD) for both the diagnosis
and therapy of NB.
Outcomes for high-risk NB patients remains poor. ~50-70% of patients diagnosed with NB will be
classified as high-risk. The 5-year overall survival for this cohort remains at less than 50%25. Current
available therapies for relapsed NB have response rates of between 15% and 50%, higher for those
with favourable risk stratification. For patients who survive first relapse, 50-90% will have a further
relapse within 5 years26.
Heterogenous characteristics of NB has created difficulties in management. Research has had a clear
focus on more targeted therapies. NB is highly heterogeneous, partly because a) it arises from tissues
undergoing rapid differentiation during fetal development, and b) the transition from normal to
malignant tissue can occur at multiple points in development. Therefore, some tumours are rapidly
proliferative but regress over time, and other tumours grow more slowly but are highly malignant27. Source: American Childhood Cancer Organization.
The heterogenous characteristics of NB have made the diagnosis and subsequent treatment difficult
to determine and assess, only exasperated by the rare nature of the disease. Over the past two
decades, the incorporation of clinical (i.e. patient age), pathologic (i.e. metastases) and, most recently, genetic factors (i.e.
MYCN gene amplification) have enabled the classification of patients based on the risk of recurrence and has enabled
tailoring of therapy based on prognosis (INGRSS).
Diagnosis can usually be confirmed by urine catecholamines and imaging. Whilst catecholamines are hormones
important for regular function in the central nervous system, they are also made by tumour cells and are often elevated in
children with neuroblastoma. Their presence can be detected by the amount of homovanillic acid (HVA) and
vanillylmandelic acid (VMA) in the blood or urine23. Imaging tests, including CT, MRI and targeted meta-
iodobenzylguanidine (MIBG) scans, are conducted to identify the site(s) of the disease, particularly as NB can metastasize
via lymph nodes and/or blood spread with the most common metastatic sites being lymph nodes, bone marrow, bone,
liver, lungs, and the brain (Figure 23). A biopsy of the primary site (or bone marrow for staging purposes) is required
however to establish the biology (i.e. MYCN gene presence) and risk stratification. Like most cancers, detection of the
disease at an early stage has a bearing on the outcome. In addition, the outcome is likely to be even better if the child is
younger at the time of diagnosis (less than 18 months). Hence, trials for screening of NB in infants using urinary
catecholamine levels were initiated many years ago28 in infants. However, it was found that the NBs detected by this
method had good biologic features and probably would have undergone spontaneous regression without manifesting
clinically29. These findings place an even greater emphasis on accurate diagnostic imaging options.
The development of targeted diagnosis and therapy of neuroendocrine tumours (NETs) has formed the basis of emerging
NB therapies. Somatostatin analogs have been used in diagnosis and treatment of neuroendocrine tumors (NETs) for
many years. Radiolabeled (using 64Cu and 68Ga) DOTA-conjugated peptides have been commercialized that bind specific
SSTRs, namely SSTR2. These agents used with PET/CT have demonstrated superior sensitivity and specificity for clinical
detection of NETs compared to previous standard of care (octreotide scintigraphy). Given that ~80% of NB cells express
SSTR2, data from clinical trials in NETs management has formed the basis of developing targeted diagnostics and
therapies for neuroblastoma.
23American Cancer Society. (2021). Neuroblastoma. https://www.cancer.org/cancer/neuroblastoma.html

24Siegel et al. (2021). Cancer Statistics, 2021. CA Cancer J Clin 71: 7- 33. https://doi.org/10.3322/caac.21654
25Yan et al. (2020). Comparison of incidence and outcomes of neuroblastoma in children, adolescents, and adults in the United States: a Surveillance, Epidemiology, and End
Results (SEER) program population study. Medical Science Monitor: International Medical Journal of Experimental and Clinical Research, 26, e927218-1.
26Pinto et al. (2019). Predictors of differential response to induction therapy in high-risk neuroblastoma: a report from the Children's Oncology Group (COG). European Journal
of Cancer, 112, 66-79.

27Shohet et al. (2017). Neuroblastoma. BMJ. 357 :j1863 doi:10.1136/bmj.j1863
28Sawada et al. (1984). Mass screening for NBin infants in Japan: interim report of a mass screening study group. The Lancet, 324(8397), 271-273.
29Weinstein et al. (2003). Advances in the diagnosis and treatment of neuroblastoma. The Oncologist, 8(3), 278-292.

A2.2.2 Imaging NB
Figure 24: International NB Risk Group Staging System (INRGSS)
Standard of care. The International Stage Description

Neuroblastoma Risk Group Staging System
The tumour is located only in the area where it started; no image-
(INRGSS) was developed through international L1
defined risk factors (IDRFs) are found on imaging scans, such as a
consensus to provide a presurgical staging (Previously stage 1)
CT or MRI scan.
system that uses clinical data and imaging to
facilitate comparisons across international NB The tumour has not spread beyond the area where it started and
L2
clinical trials and cases30 (Figure 24). the nearby tissue; IDRFs are found on imaging scans, such as a CT
(Previously stage 2A/2B)
Locoregional tumors are staged as L1 or L2 or MRI scan.
based on the absence or presence of Image-
Defined Risk Factors (IDRFs), respectively. In M The tumour has spread to other parts of the body (except stage
order to complete staging, bone marrow (Previously stage 3/4) MS, see below).
involvement is assessed by examination of
aspirates and biopsies, and cross-sectional and MS Metastatic disease in children <18 months old with metastases
123I metaiodobenzylguanidine (MIBG) scans are (Previously stage 4S) confined to the skin, liver, and/or bone marrow
used to determine metastatic spread (defining M Source: INGRSS.
and MS stages).
MIBG scans emerged as the new SOC. MIBG concentrates in adrenergic tissues, that is tissues Figure 25: Flowchart of NB
which have certain hormones, such as those related to the aforementioned HVA and VMA. imaging workup at diagnosis
MIBG has demonstrated high sensitivity and specificity in NB detection. In the past 3 decades,
whole-body imaging using radiolabeled MIBG has become a standard of care method for
staging and monitoring treatment response (Figure 25). It is necessary to note that ~10% of
NB tumours do not incorporate MIBG, and in these cases 18-fluorodeoxyglucose (18F-FDG) is
currently recommended26. Figure 25 also highlights the current complex nature of diagnostic
imaging in NB tumours given their propensity to metastasize to various sites, usually resulting
in significant cost outlays, reflected in Figure 26.
Figure 26: Estimated costs for SOC in high-risk NB patients

Private
Diagnostic test CMS avg. Est. EU
insurance
(no. of tests) cost32 cost34
cost33
MIBG SPECT-CT 1,580 3,539 2,265
Chest x-ray 90 202 129
MRI 4,56 1,021 1,961
US 137 307 1,96
Bone scintigraphy 426 954 1,221
Chest CT 237 531 3,40
Brain imaging 455 1,019 6,52
Total $3,381 $7,573 $4,847 Source: Brisse et al.31
Source: Centres for Medicare and Medicaid (CMS), Wilsons.
SPECT scans like MIBG generally have limitations. Despite the high diagnostic accuracy of MIBG imaging, there are
several disadvantages of MIBG imaging, including a) limited spatial resolution and sensitivity in small lesions, b) a
requirement for prolonged sessions in the SPECT scanner needed to acquire an effective scan and c) a delay between
the start of the examination and results. Prolonged sessions are a particular disadvantage for small children because it
increases the length of time for which they need to be sedated whilst undergoing the scan. Furthermore, in most cases,
MIBG imaging is not sufficient for operative or biopsy planning. Most of these disadvantages can be overcome with PET,
due to its higher spatial resolution and the possibility of a whole-body tomography versus SPECT with a limited field of
view. PET or PET/CT is completed in one examination within 30 minutes to 60 minutes after injection versus MIBG
scintigraphy with SPECT or SPECT/CT requiring at least 18 -24 hours to reach a desirable tumor-to-background ratio.
The resulting shorter scanning time of PET has the potential for reducing the number or length of sedations. MIBG also
requires co-administration of an oral medication for thyroid protection. Figure 27 demonstrates the increased resolution
by using PET imaging and, more specifically the tumour delineation of 64Cu SARTATE. These are some of the benefits
over current SOC imaging that Clarity are seeking to highlight in their Phase I/IIa CL04 trial in NB patients. Further
information from this trial is expected in 1H23.
Figure 27: Comparison between A) 123I-MIBG scan B) 64Cu SARTATE for

30Monclair T et al. (2009) The International Neuroblastoma Risk Group (INRG) Staging System: An INRGtumours
Neuroblastoma Task Force Report. J Clin Oncol. 27(2): 298-303.
31Brisse et al. (2011). Guidelines for imaging and staging of neuroblastic tumors: consensus report from the International Neuroblastoma Risk Group Project. Radiology, 261(1),
243-257.
32https://www.medicare.gov/procedure-price-lookup/
33Whaley et al. (2020). Nationwide evaluation of health care prices paid by private health plans: findings from round 3 of an Employer-Led transparency initiative. RAND.
34Tikkanen and Abrams. (2020). U.S. Health Care from a Global Perspective, 2019: Higher Spending, Worse Outcomes? https://doi.org/10.26099/7avy-fc29.

18FDG is used for non-avid MIBG patients. 18 FDG is a PET imaging

agent that is primarily used for patients that are negative on the MIBG
scans (~10% of NB cases). However, due to its lower sensitivity, the
role of 18 FDG in the imaging of patients with NB remains
controversial, particularly as there have been few studies focused on
this agent. The principal limitation of 18 FDG is the non-specific bone
marrow uptake during chemotherapy. Whilst PET imaging is of
increasing interest for patients with neuroblastoma there are currently
no approved PET products on the market. This is a clear market gap
that Clarity hope to fill with their 64Cu-SARTATE agent.
Early, accurate imaging is crucial for subsequent treatment

determination. The ability to identify early prognostic factors of
response may significantly affect decisions about subsequent therapy
and help identify the individuals who may benefit from augmented or
alternative treatment. Additionally, given the rapidly changing nature
of the disease, it is crucial to continuously monitor and assess
potential metastases that may arise, in a feasible manner, particularly
as disease recurrence has such a poor prognosis. There are only a
handful of diagnostic agents in development for NB, two which have
the same mechanism of action (MOA) as MIBG (norepinephrine
transporter, NET-1) and one, akin to Clarity, targeting SSTR2. Given
the differences in visual acuity between CT and PET scans, it is
difficult to accurately assess whether NET-1 presents as a better
target for neuroblastoma. It is likely that there are a higher number of
NET-1 avid tumours (uptake in ~85-90% of NB tumours) however the
clinical utility of NET-1 agents is hindered by poor image resolution
(at present).
64Cu SARTATE studies in mice show promising results to overcome

existing limitations for SSTR2-expressing neuroblastomas. One of the
most crucial issues of PRRT, especially in the case of paediatric
patients, is the need to obtain an accurate estimation of the dose
delivered to tumors and to healthy organs. The short half-life of 68Ga
radionuclides hampers an accurate biodistribution and tissue clearance study through PET/CT prior to LUTATHERA
therapy (177Lu-DOTATATE PRRT). 64Cu with its longer half-life and its desirable positron emission, can be utilised for
dosimetric and biokinetic studies that aid in selection and PRRT administration (using 67Cu). In early studies conducted in
mice, compared with 64Cu-DOTATATE (DETECTNET™), 64Cu SARTATE demonstrated excellent and selective binding to
SSTR2 expressing tumors at 2 h post-injection. Most importantly, while 64Cu-DOTATATE uptake in tumors decreases at
24 h, the incorporation of 64Cu SARTATE remains stable, with higher target-to-background contrast at later time points.
These studies highlighted that 64Cu SARTATE presented lower accumulation in non-target organs such as the kidneys,
liver, and lungs compared to 64Cu-DOTATATE35.
64 Cu SARTATE under investigation in NB following initial clinical signals in NETs patients. The preliminary results from a
Phase I study in NETs (n=10) with 64Cu SARTATE (NCT04440956), has provided adequate preliminary safety and
diagnostic efficacy data to support further development of this PET agent in NB. Clarity are currently engaged in a Phase
I/IIa trial in NB to evaluate SARTATE bound radionuclides as both diagnostic (64Cu) and therapeutic (67Cu) agents
(NCT04023331). We expect further clinical readouts from this trial in 1H23.
A2.2.3 Current therapeutic options
Treatment is tailored according to the risk assignment. In the INRG classification system, a combination of clinical,
pathologic, and genetic markers are used to predict the clinical behavior of the tumor and how it will respond to
treatment. These factors include stage of disease (Figure 24, p.27), presence or absence of MYCN amplification, genetic
basis of tumours (chromosomal changes), appearance of tumour and age (younger children often have better survival
rates). Using the aforementioned factors, each NB is classified into 1 of 4 categories: very low-risk, low-risk,
intermediate-risk, or high-risk and treated based on this classification.
Figure 28 summarises the characteristics and current treatment SOC based on neuroblastoma risk categories. Patients
categorised as very-low and low risk (Stage L1-L2 and MS) are unlikely to be candidates for advanced treatments, given
their favourable overall survival rates and tendency to allow for tumor regression without intervention. It must be noted
that the very low and low risk group account for a small population of neuroblastoma cases, and, are fairly likely to have
recurrence at a later date. Patients with intermediate risk NB (Stage L2-M) are treated similarly to high-risk patients at a
lesser intensity. Current trials represent an interesting point to consider in this category given the potential to uncover
more personalized treatment options based on certain factors determined by the INRGSS. The number of chemotherapy
35Paterson et al. (2014). PET imaging of tumours with a 64 Cu labeled macrobicyclic cage amine ligand tethered to Tyr 3-octreotate. Dalton Transactions, 43(3), 1386-1396.

cycles is particularly critical given that the average age of a NB patient is ~18 months, making the frequency and amount
of chemotherapy limited. This presents as a potential expansion opportunity for Clarity, to offer a safer, more effective
treatment, particularly for intermediate patients, with new data, may be more so classified as high risk. Patients with
high-risk disease (stage M), require significantly more complex treatment including radiotherapy, different types of high-
dose chemotherapy, stem cell transplantation, biologic and immunotherapies which per US patient costs
~US$432,68836 per year. Despite intense multimodal therapy, patients within this cohort have a poor prognosis with an
event-free survival of <50%22. New therapies and clinical trials for neuroblastoma, are most often focused on this
category, given the low efficacy in currently available treatments.
Figure 28: Risk categories for neuroblastoma
Very low and low-risk Intermediate risk High risk
Percentage of overall cases <10%25 20-30%25 50-70%+25

Overall survival 96% 23 80% 25 50%25
• Surgery • Surgery • Induction therapy (surgery, chemo)
• “Wait and watch” • Consolidation therapy (chemo, radiotherapy,
• Chemo/radiotherapy
Current SOC approach stem cell transplant
• Maintenance therapy (anti-GD2 antibodies +

isotretinoin
• Long term outcomes of • Number of cycles of chemo based

Potential advances in • Figure 33 summarises the current ongoing
wait and watch on chromosomal changes, tumour
treatment clinical trials for high-risk neuroblastoma.
approach vs. surgery. histology, stage and age of patient.
Source: as referenced, Wilsons.
MIBG radiotherapy is the current SOC for relapsed high-risk neuroblastoma. Many high-risk patients will receive 131I-
MIBG therapy although it is not an FDA approved agent for use in the indication. It has shown promising results with a
30-40% response rate, especially in high-risk NB with refractory, relapsed or resistant conditions, who have received a
123I-MIBG-positive scan22. 10% of patients have a 123I-MIBG negative scan and therefore are not suited for this treatment.
Whilst data has shown some positive results, 131I-MIBG therapy is an extremely intense and logistically laborious option,
requiring patients to be isolated in a lead lined room at the hospital for several days after administration. We assess a
~60% relapse rate over 5 years37.
A2.2.4 Competitive landscape for NB therapeutic development
67Cu SARTATE shows promise in animal models. Cullinane et al.36 administered subcutaneous xenografts with saline,
177Lu-LuTATE or 67Cu SARTATE to different groups of mice bearing high SSTR2 expressing tumours. Following
randomised administration, it was demonstrated both 177Lu-LuTATE and 67Cu SARTATE were capable, with equivalent
effectiveness, of significantly reducing tumor growth in comparison to the control group (saline). Furthermore, the
fractioned delivery of 67Cu SARTATE in two administrations was more effective at prolonging survival (46 days vs 35
days; p = 0.04) in comparison with the administration of a single dose38. A study conducted in hepatic (liver) metastases
from NB demonstrated the effectiveness of 67Cu SARTATE in treating minimal residual disease (MRD). One of the most
crucial challenges in NB management is relapse after initial response to chemotherapy. Whilst treatment was
administered at 2 and 4 weeks, only the treatment performed at 2 weeks after tumor inoculation was effective at
extending survival with respect to the control groups, therefore suggesting that PRRT with 67Cu SARTATE might be a
valuable tool to control small tumors. Further information will be available later this year from Clarity’s Phase I/IIa CL04
trial (NCT04023331). The phase I/II trial is aimed at assessing the highest safe dose of 67Cu SARTATE in high-risk
neuroblastoma. Given the lack of currently available data, and the somewhat inconsistent results seen in previous trials
(albeit using different radioisotopes), this trial will be critical to assess the potential future utility of 67Cu SARTATE in this
setting.
Previous radiopharmaceutical trials have shown promising but somewhat inconsistent results. With a lack of data
available from Clarity, we look to previous trials assessing the use of radiotherapeutics in NB summarized in Figure 29.
Majority of these trials have been conducted with the most common 68Ga/177Lu-DOTATATE pairing. Whilst there have
been varying results demonstrated, the below studies suggest there is efficacy in at least a certain subset of NB patients,
which is expected given the heterogenous nature of the disease, and the current multi-faceted treatment approach. The
additional benefits associated with SARTATE, including the accurate dosimetry prediction with the copper pairing may
fair well for Clarity given this may have affected administering the correct dose in previous studies.
36De Oliveira et al. (2017). Costs for childhood and adolescent cancer, 90 days prediagnosis and 1-year postdiagnosis: a population-based study in Ontario, Canada. Value in
health, 20(3), 345-356.
37Yan et al. (2020). Comparison of Incidence and Outcomes of NBin Children, Adolescents, and Adults in the United States: A Surveillance, Epidemiology, and End Results
(SEER) Program Population Study. Medical science monitor: international medical journal of experimental and clinical research, 26, e927218.
38Cullinane et al. (2018). Comparing the therapeutic efficacy of 67Cu-SARTATE and 177Lu-DOTA-octreotate in a neuroendocrine tumor model.

Figure 29: Previous clinical trials assessing the use of radiopharmaceuticals in SSTR2-positive tumours
Reference/Year n Theranostic Pairs Primary endpoint outcomes
Preclinical studies
• PRRT with 177Lu-DOTATATE and 67Cu SARTATE was assessed based on tumour size and
Cullinane et al. 177Lu-DOTATATE survival.
N/A
(2018)39 /67Cu SARTATE • Both groups were P<0.0004 vs control in reducing tumour growth.
• Both groups were P<0.001 vs control in survival increase.
• Adequate 64Cu-SARTATE tumour uptake was observed at 25% injected activity per gram of
tissue.
Dearling et al. Cu/67Cu
64
N/A • 67Cu SARTATE therapy was effective 2 weeks after tumour inoculation, p=0.012 vs control in
(2021)40 SARTATE
extending survival. No significant effect was observed 4 weeks after tumour inoculation,
suggesting efficacy in small tumours.
Clinical studies
• Of 8 children imaged with 68Ga-DOTATATE, 6 had abnormally high uptake.

Gains et al. Ga/177Lu-
68
8 • Of 6 children treated with 177Lu-DOTATATE, 5 had stable disease by RECIST standards,
(2011)41 DOTATATE
suggesting therapeutic efficacy.
• Isotope pairs were selected based on type of disease (111In less toxic with marrow involvement).
• 68Ga-DOTATATE showed additional disease (vs MIBG) in 3/8 patients and upstaged 1 patient.
Kong et al. Ga/177Lu/111In/90Y
68 6/8 patients were deemed suitable for PRRT based on uptake score >3.
8
(2016)42 DOTATATE • No renal toxicities were reported with use of the treatments.
• All patients who received treatment had early objective responses. 2 patients subsequently died
as a result of progression of disease.
• This trial was conducted in adult NETs patients.

Hicks et al. • PET/CT with 64Cu SARTATE was comparable to 68Ga-DOTATATE in 9/10 patients. One patient
10 64Cu-SARTATE
(2019)43 had superior definition of small liver lesions on 68Ga-DOTATATE (judged by 2/3 readers).
However, the 4h and 24h scans were judged by all readers as superior.
• 20 patients were identified as eligible for treatment with 68Ga-DOTATATE.

• 14 patients were considered eligible for treatment with 177Lu-DOTATATE (after 6 died before
Gains et al, Ga/177Lu-
68
21 treatment start). 0/14 had response either by the original or by the revised INRC criteria at 1
(2020)44 DOTATATE
month after completion of treatment.
• Dosing in the study was considered low – 2.3 Gy (vs. normal of 4 Gy).
• 68Ga-DOTATATE was positive in 10/14 patients.

Fathpour et al. Ga/177Lu-
68
14 • 5 patients received 177Lu-DOTATATE treatment. 2 patients showed complete response, 1 patient
(2021)45 DOTATATE
showed partial response. 2 patients showed progressive disease.
Source: as referenced.
Two new NB therapies could be approved by end of 2022 – both from Y-mAbs Therapeutics. DANYELZA™ represents
the first FDA approved treatment for NB (albeit for a subset of patients). Naxitamab (DANYELZA™), a humanised (IgG1)
anti-GD2 (hu3F8) monoclonal antibody, was developed by the Memorial Sloan Kettering Cancer Center (with
commercial rights licensed to Y-mAbs Therapeutics) for the treatment of neuroblastoma, osteosarcoma and other GD2-
positive cancers. Naxitamab was granted FDA approval in 2020 for marketing as treatment (in combination with
granulocyte-macrophage colony-stimulating factor) for paediatric patients at least one year of age and adult patients
with relapsed or refractory high-risk NB in the bone or bone marrow demonstrating a partial response, minor response,
or stable disease to prior therapy. DANYELZA© is currently used in the late stages of high-risk NB therapy, specifically
for bone marrow metastases. Y-mAbs Therapeutics estimate this addressable population to be 300 out of a total 800
incident NB patients per year (Figure 30).
39Cullinane et al. (2018). Comparing the therapeutic efficacy of 67Cu-SARTATE and 177Lu-DOTA-octreotate in a neuroendocrine tumor model. Journal of Nuclear Medicine
59 (supplement 1) 315.
40Dearling et al. (2021). Detection and therapy of neuroblastoma minimal residual disease using [64/67Cu] Cu-SARTATE in a preclinical model of hepatic metastases. EJNMMI
research, 11(1), 1-14.

41Gains et al. (2011). 177Lu-DOTATATE molecular radiotherapy for childhood neuroblastoma. Journal of Nuclear Medicine, 52(7), 1041-1047.
42Kong et al. (2016). Initial experience with gallium-68 DOTA-octreotate PET/CT and peptide receptor radionuclide therapy for pediatric patients with refractory metastatic
neuroblastoma. Journal of pediatric hematology/oncology, 38(2), 87-96.

43Hicks et al. (2019). 64Cu-SARTATE PET imaging of patients with neuroendocrine tumors demonstrates high tumor uptake and retention, potentially allowing prospective
dosimetry for peptide receptor radionuclide therapy. Journal of Nuclear Medicine, 60(6), 777-785.
44Gains et al. (2020). A phase IIa trial of molecular radiotherapy with 177-lutetium DOTATATE in children with primary refractory or relapsed high-risk neuroblastoma.
European Journal of Nuclear Medicine and Molecular Imaging, 47(10), 2348-2357.

45Fathpour et al. (2021). Feasibility and therapeutic potential of combined peptide receptor radionuclide therapy with intensive chemotherapy for pediatric patients with
relapsed or refractory metastatic neuroblastoma. Clinical Nuclear Medicine, 46(7), 540-548.

Similarly, omburtamab (8H9) (commercialized as OMBLASTYS®), a murine antibody recognising B7-H3 linked to 131I-
Burtomab, is being developed to treat children with Central Nervous System (CNS) neuroblastoma. Patients in the Phase
I study were administered up to 2 doses of OMBLASTYS®. In 107 evaluable patients, the median survival with
OMBLASTYS was 50.8 months with the final median not reached (i.e. they did not reach the point at which >50% of
patients died). The findings reported in 2019 were comparable with prior reported data of a 47.1-month survival in a
group of 93 patients. In 68 patients with other CNS cancers, investigators identified that grade 1/2 fever, headache, and
vomiting were rare adverse events (AEs) observed in these patients. Grade 3 chemical meningitis, and increasing
hydrocephalus (water on the brain) were AEs requiring discontinuation of the agent. On 31 May 2022 Y-mAbs
Therapeutics received FDA acceptance of their Biologics License Application (BLA) for OMBLASTYS®, with a priority
review of their application. The PDUFA date is set as Nov 30, 2022.
Figure 30 outlines the addressable population of both DANYELZA and OMBLASTYS©, noting that both drugs only
address a specific population within the total NB incidence population. There is possibility that DANYELZA© moves into
a front-line setting, however based on current protocols this is not the case. If both products were to treat their full
addressable population (including DANYELZA in the front-line setting), based on the 800 cases in the US per year, 270
new neuroblastoma patients would remain untreated and easily accessible for Clarity to establish market share.
Additionally, there is no evidence to currently suggest that SARTATE would not be eligible within the populations of
DANYELZA and OMBLASTYS.
Figure 30: Neuroblastoma US incident addressable population with Y-mAbs therapeutics drugs vs Clarity’s positioning in this indication
Source: Y-mAbs Therapeutics, Wilsons.
67Cu SARTATE will first target high-risk patients with potential expansion into the front-line setting. Y-mAbs products
are expected to be used in the consolidation phase of high-risk NB therapy. Whilst no data is currently available to
assess safety and efficacy of 67Cu SARTATE in NB patients, data from pre-clinical models suggest that it may be more
efficacious in smaller tumours. If 67Cu SARTATE is able to demonstrate improvement vs current SOC, the unique
characteristics of 67Cu SARTATE may present a further opportunity for Clarity to expand their addressable population
into a 1st line high-risk setting.
Further down the line, this may also expand into lower risk groups, particularly patients in the intermediate risk group
who are more likely to need intense treatment. This may allow Clarity to address 70-85% of the total NB patient
population (~600-700 patients). At this stage we estimate an addressable peak sales market of ~240 patients per year
the US (FY31) representing $118m in sales.
Trial updates. The company noted at the FY22 the trial was progressing well, completing cohort 1 in January 2022 and
cohort 2 in August 2022. Participants with neuroblastoma received therapy with 67Cu SARTATE at a dose of 75 MBq/kg
body weight in cohort 1 and 175 MBq/kg body weight in cohort 2. The increase in administered activity between cohorts
1 and 2 is significant in radiation-sensitive diseases such as neuroblastoma. No dose limiting toxicities were reported in
either cohort and the Safety Review Committee recommended that the trial continue with the dose escalation phase as
planned. Recruitment of cohort 3 began in August 2022, across 5 US clinical sites, with a planned increase in 67Cu
SARTATE administered of 275 MBq/kg body weight.

A2.2.5 Other products in development & key dates
Aside from the Y-mAbs Therapeutics agents there are a number of other products under investigation in clinical studies.
These are summarised in Figure 31 We note three programs with 2H 2022 readouts.
Figure 31: Ongoing clinical trials for the treatment of neuroblastoma

Trial Phase Radiopharmaceutical product Indication Primary completion date
NCT02914405 I 131I-MIBG with Dinutuximab-beta and nivolumab R/R high-risk June 2022 (awaiting results)
NCT03332667 I 131I-MIBG with Dinutuximab +/- Vorinostat R/R high-risk Sept 2022 (awaiting results)
Recurrent/Progressive high-
NCT03561259 II 131I-MIBG +/- Vorinostat Dec 2022
risk
I-MIBG +Topotecan or;

131 High-risk with insufficient
NCT03165292 II June 2023
Thiotepa high dose chemo with stem cell transplant response to induction therapy
CNS or leptomeningeal
May 2026
NCT03275402 II/III 131I-omburtamab (Omblastys©) relapse
NCT04903899 II 177Lu-DODATATE R/R high risk May 2026
NCT03126916 III 131I-MIBG or ALKI Newly diagnosed high-risk Sept 2026

R/R = refractory/recurrent disease, CNS = central nervous system,
Source: Clinicaltrials.gov
Current clinical trials for NB therapy are largely focused on use of 131I-MIBG with chemotherapy. Given the demonstrated
efficacy of MIBG in NB following three decades of use, the vast majority of clinical trials are assessing the use of different
chemotherapy agents in conjunction with 131I-MIBG radiotherapy to optimise current practice. This is encouraging for
Clarity as there is a clear focus to develop a theranostic pairing in the space. If Clarity are able to generate data which
shows enhanced imaging and therapeutic efficacy of 64Cu SARTATE/67Cu SARTATE, compared to MIBG, it is realistic to
envisage this becoming a new SOC in the management of high-risk NB.

 A2.3 PSMA-positive prostate cancer
PSMA-directed PET/CT imaging is rapidly becoming the new standard of care in the diagnosis and staging of prostate
cancer. The National Comprehensive Cancer Network (NCCN) guidelines were updated in September 2021 and
unequivocally say that PSMA PET should also be considered as an alternative to standard first-line imaging techniques
including CT, MRI, bone scan and 18F-fluorodeoxygluose PET. Furthermore, PSMA PET has increased sensitivity
compared to two previously approved PET agents: 11C-choline and 18F-fluciclovine (for small lesion characterization).
Following surgery 20-30% of patients are operated on for localised tumours relapse, with most disease recurrence
occurring within three years.
US FDA has approved four agents and the market is developing rapidly. Figure 32: TAM metrics for PSMA-directed PET/CT in USA market
The first approved agent was a 68Ga-PSMA11 sponsored by University of Product
California, Los Angeles (UCLA) and the University of California, San
Metastatic castrate
Francisco (UCSF). The UCLA/UCSF approval was limited to radiology
Indication focus resistant prostate cancer
facilities attached to those institutions and must be manufactured and
(mCRPC)
labelled with 68Ga derived from UCLA’s Biomedical Cyclotron. In May
US new cases, annually 269,000
2021, FDA approved Lantheus’ PYLARIFY (18F-piflufolastat) which became
the first widely available agent, which has guided to US$400M sales in Prevalence population (millions) 3.1
CY22. Two ‘cold kit’ versions of 68Ga-PSMA11 have also since been Primary diagnosis scan volume 130,00046
approved and are available: a) ILLUCCIX (owned by Telix Pharmaceuticals
Disease recurrence scan volume 90,00047
and distributed via Cardinal Health and other channel partners); and b)
LOCAMETZ (Novartis’ companion diagnostic to their radioligand therapy Monitoring and RLT selection scan volume 30,00048
PLUVICTO). We estimate potential demand for at least 250,000 PSMA Potential annual scan volume (per annum) 250,000
PET scans in the USA per year (FY23e basis) representing a total
addressable market (TAM) of over US$1.1B (Figure 32). Source: Wilsons, as referenced.
A2.3.2 SAR-bisPSMA design and rationale
Two PSMA’s appear better than one. Clarity’s agent features a ‘caged’ copper isotope at its centre (akin to their
SARTATE agent), flanked by two identical structures that bind to PSMA (Figure 33). The intention of providing a bivalent
molecule (2x PSMA-binding motifs vs just 1) was based on the observation that bivalent antibodies tend to exhibit
superior surface binding, internalization and retention within cancer cells. Pre-clinically, this appears to be the case with
the bivalent agent showing more favourable kinetics when compared to the monomer. The PSMA-binding ‘motifs’ at
each end of the SAR-bisPSMA molecule are the same peptidomimetic “Lysine-uriedo-Glutamine” structures found in
both Telix’s ILLUCCIX and Novartis’ radioligand therapy PLUVICTO49. The use of hydrophobic, diphenylalanine-based
linkers improves the molecule’s metabolic stability. The synthetic chemistry reactions producing SAR-bisPSMA (and its
intermediates) are identical in terms of reaction conditions and high yield for both 64Cu and 67Cu. Similarly, biodistribution
and pharmacokinetic behavior is expected to be similar between the two isotope-bound agents.
Figure 33: General structure of SAR-bisPSMA. Two PSMA-binding motifs are attached via linker molecules to either 64Cu or 67Cu complexed
with a sarcophagine chelator structure.
Source: Source: McInnes (2021)50, Wilsons.
46Lantheus R&D Day May 2022. Restricted to primary staging of high, very high risk and/or metastatic disease at presentation.
47Scher, H. I. et al. (2015) Prevalence of prostate cancer clinical states and mortality in the United States: Estimates using a dynamic progression model. PloS one 10:
e0139440.
48Lantheus estimate for the treatment of adult patients with PSMA-positive metastatic castration-resistant prostate cancer who have already been treated with other
anticancer treatments (androgen receptor pathway inhibition and taxane-based chemotherapy).

49Zia, N. A. et al. (2019) A bivalent inhibitor of prostate specific membrane antigen radiolabelled with Copper-64 with high tumor uptake and retention Angew. Chem. Int. 58:
14991 –14994.
50 McInnes, L. E. et al. (2021) Therapeutic efficacy of a bivalent inhibitor of prostate-specific membrane antigen labeled with copper-67 J. Nuc. Med.
Doi:10.2967/jnumed.120.251579.

Figure 34: Common questions relating to the use of PSMA-directed PET for prostate cancer.
Question Recommendation Rationale/Comment
Differences between agents are minimal compared with the
Which type of PSMA PET For initial staging or localization of biochemical recurrence,
improvements in sensitivity and specificity over other imaging
should be performed? use whichever agent is available.
modalities.
With enlarged soft-tissue disease on cross-sectional
imaging manage as you would metastases identified on
How should treat patient
traditional imaging. In the current era (with PSMA PET available but no long-term
with metastatic disease that
With bone metastases obtain a bone scan to stratify the risk outcome data), use the best available data and extrapolate
was first identified on initial-
for disease volume. when necessary.
staging PSMA PET?
With disease ONLY identified on PSMA PET, if high-(locally
advanced) criteria are otherwise met, treat as such.
How should we use PSMA If a limited number of metastatic sites are identified based on PSMA PET is a more sensitive imaging modality that may
PET in the setting of other imaging modalities, and serum PSA is elevated obtain identify additional sites of disease; patients in the ORIOLE study
oligometastatic disease? PSMA PET prior to metastasis-directed therapy. who were "undertreated did not do as well.
What is the utility of PSMA Based on inclusion criteria for randomized trials; individual
Treatment selection for small molecules: use study inclusion
PET for castration-resistant discussion of risks/benefits suggested; may not apply to other
criteria.
disease? modalities of PSMA-directed therapy.
Source: Tagawa (2022).51
Putative advantages over current PSMA-PET agents. All available PSMA-directed PET agents are based on small
molecules that target the PSMA molecule in similar ways. All have limitations that could lead to misdiagnosis or
mismanagement of patients53. Key opinion leaders have recently published a ‘key questions’ thought piece to assist US
practitioners in their adoption of PSMA PET (Figure 34) but this table also helps conceive ‘gaps’ where a new agent like
SAR-bisPSMA may play a niche role.
The 64Cu/67Cu theranostic pairing not yet seen in any approved agents. Closely matched, chemically and
Figure 35: Image showing high
biologically equivalent isotopes may translate to closer alignment between tumour imaging results (64Cu) and
urinary excretion of urea-based
subsequent treatment with radioligand therapy using 67Cu. The theranostic alignment between 177Lu-based
PSMA agent in the urinary
PLUVICTO and 68Ga-based PET (ILLUCIX, LOCAMETZ) was empirical at best, but was good enough to support
bladder (arrow).
FDA approval. Equally, clinical guidelines developed quickly to include 18F-based PYLARIFY in assessing
PLUVICTO candidacy. Early practice with PLUVICTO seems similarly agnostic on modality choice, but does
favour consistency (use the same scan for base line and all follow-ups).
Image quality for improved microscopic lymph node metastases. Image quality with 64Cu should compare well
with 18F and be better than 68Ga on account of its low positron emission energy (~0.6 MeV compared to 1.9 MeV
for 68Ga). Lower positron energies correspond to shorter deceleration distances in human tissues, providing better
image resolution54. This property, combined with higher tumour uptake and longer half-life, may give SAR-
bisPSMA a greater sensitivity/specificity in situations where ILLUCCIX/PYLARIFY do less well. The large clinical
trials on which PYLARIFY’s approval was based missed its sensitivity endpoint in the recurrence setting for pelvic
nodal metastases55. Equally, a negative ILLUCCIX scan does not rule out microscopic lymph node metastasis56.
Image quality for improved detection of localized recurrence. Both ILLUCCIX and PYLARIFY are based on small
molecule PSMA antagonists that are rapidly excreted by the kidneys and collect in the urinary bladder. This leads
to a high concentration of radioactive signal as background which can make it difficult to visualize local recurrence
and pelvic lymph node metastases in the prostatic bed. PSMA agents that have slower renal excretion (Blue
Earth’s 18F-fluciclovine and 18F-rhPSMA-7.3) or different pharmacokinetics (18F-PSMA-100757, 18F-CTT1057 and
18F-JK-PSMA-7) may be better at detecting curable localized disease in close anatomical relation to the urinary
bladder58. This aspect of SAR-bisPSMA is being assessed in Clarity’s SECURE study (Figure 35). The longer half- Source: Wondergem (2021)52
life may permit extended imaging to enhance the detection of small metastatic lesions in areas with relatively
high non-specific background59.
51 https://dailynews.ascopubs.org/do/10.1200/ADN.22.200864
52 Wondergem, M. et al. (2021) Matched-pair comparison of 18F-DCFPyL PET/CT and 18F-PSMA-1007 PET/CT in 240 prostate cancer patients: interreader agreement and
lesion detection rate of suspected lesions J. Nucl. Med. 62: 1422 – 1429.
53 Shetty, D. et al. (2018) Pitfalls in Gallium-68 PSMA PET/CT interpretation – a pictorial review Tomography 4: 182 – 193.
54 Spratt, D. E. et al. (2018) Management of biochemically recurrent prostate cancer: ensuring the right treatment of the right patient at the right time. Am Soc Clin Oncol Educ
Book. 38:355–62.
55 Pienta, K. J. et al. (2021) A phase 2/3 prospective multicenter study of the diagnostic accuracy of prostate specific membrane antigen PET/CT with 18F-DCFPyL in prostate
cancer patients (OSPREY) J. Urol. 206: 52 – 61.

56 Moreira, L. F. et al. (2022) Accuracy of 68Ga-PSMA PET/CT for lymph node and bone primary staging in prostate cancer Urol. Onc. Semin. Orig. Invest. 40: 104.e17 –
104.e21
57 Agent developed by University of Heidelberg and DKFZ under exclusive license to ABX Advanced Biochemical Compounds. Association with non-specific bone uptake has
limited the commercial development of this PSMA radiotracer.

58 Pernthaler, B. et al. (2019) A prospective head-to-head comparison of 18F-fluciclovine with 68Ga-PSMA11 in biochemical recurrence of prostate cancer in PET/CT Clin.
Nucl. Med. 44: e566 – e573.

59 Hoberück, S. et al. (2019) Dual-time-point 64Cu-PSMA-617-PET/CT in patients suffering from prostate cancer. J. Labelled Compd. Radiopharm. 62: 523−32.

A2.3.3 64Cu SAR-bisPSMA (Diagnostic imaging)
Only a small proportion of Clarity’s pre-clinical data with 64Cu/67Cu-SARbisPSMA is publicly available in peer reviewed
form. In aggregate, the data makes a convincing case for progressing the asset into human clinical trials. Furthermore, the
data also hints at some important potential differentiators from other approved and investigational PSMA-directed PET
agents for the diagnosis and clinical assessment of prostate cancer, particularly the dual-binding motif which allows
greater uptake in prostate tumours.
Cancer cell binding and internalization tested in vitro. Published research

suggests that incorporating two rather than one PSMA binding group greatly Figure 36: Binding to the cell surface and internalization of mono-
enhances the binding and internalization of the radiotracer by tumour cells. The and bivalent forms of Clarity’s 64Cu PSMA-directed PET agents.
experiment shown in Figure 36 shows binding and internalization data at 15-, The [64Cu]CuBisSarPSMA nomenclature denotes the bivalent
30- and 60-minute time points for both mono- and bivalent versions of Clarity’s molecule.
64Cu-based radiotracer49. These are in vitro data using PSMA-positive, human
prostate adenocarcinoma cells (LNCaP). Noting the caveats with comparing

across experiments by different investigators, the ~50% internalization at 60
minutes in Figure 36 compares well with internalisation rates of ~15% for 68Ga-
PSMA11, reported in the literature60.
Confirmation in mouse tumour models. Dosing LNCaP tumour-bearing mice

provided the first look at biodistribution and radiotracer uptake in vivo by
tumours and other organs. In this model, tumours are seeded in the animal’s
flank and allowed to develop before imaging. Figure 37a shows how much
better the bivalent tracer is taken up by tumour compared to monomer. Note
that 68Ga-PSMA11 behaves similarly to the monomer61. Figure 37b shows a
time series of PET images depicting take-up over 24 hours in both tumour and
kidney (an organ with normal physiological PSMA expression). The maximum
tumor standardized uptake value (SUVmax) in tumour at 1h was 11.4±1.0 and
this increased to 12.9±0.6 at 24 h (n=3). Note also that residual radiotracer is Source: Zia (2019).49
far less in kidney at 24 hours, suggesting more effective clearance.
Figure 37: a) Tumour uptake increases over time using bivalent radiotracer; b) PET images in rat show the
radiotracer taken up by tumour (T) and kidney (K) but eliminated from the latter at a faster rate.
Source: Zia (2019).49
60 Fuscaldi, L. L. et al. (2021) Standardisation of the [68Ga]Ga-PSMA-11 radiolabelling protocol in an automatic synthesis module: assessments for PET imaging of prostate
cancer Pharmaceuticals 14: 385.
61 M. Schaefer, et al. (2012) Eur. J. Nucl. Med. Mol. Imaging Res. 2: 11.

A2.3.4 67Cu SAR-bisPSMA (Therapy)
Clarity’s 67Cu SARbisPSMA offers a beta-emitting ‘theranostic’ alternative to approved and investigational radioligand
therapies for prostate cancer (Figure 39, overleaf). based on 177Lu (Novartis’ PLUVICTO, Telix’s TLX591 and
POINTBiopharma’s PNT2002). At the isotope level the energy from 67Cu and 177Lu beta emissions are similar. Clarity’s
putative advantages on the therapeutic side are similar to those already covered for the diagnostics: a) more efficient
uptake and internalization by virtue of its bivalency; and b) the shorter half-life of 67Cu (61.9 hrs compared to 6.7 days for
177Lu) conferring possible dosing advantages.
Novartis’ Phase III trial with PLUVICTO (177Lu-PSMA-617) was the first pivotal clinical trial to show that targeting
PSMA-expressing prostate cancer with directed ‘radioligand’ therapy has therapeutic benefit. Novartis’ VISION study
enrolled patients with PSMA-positive, metastatic, castrate-resistant prostate cancer (mCRPC) who had failed both
androgen receptor-directed therapy and taxane chemotherapy. VISION confirmed an overall survival (OS) benefit of 4
months with a 38% reduction in risk of death (p<0.001). The response rate with PLUVICTO was shown to be 45-55%
with multiple cycles62. These and other results convinced the FDA to approve PLUVICTO in March 2022.
Investigational programs including Clarity’s seek to improve dosing, efficacy or address earlier stage disease. Novartis’s
success provided encouragement to the entire radiopharmaceutical field, but especially to those developers with
prostate cancer assets targeting PSMA63. Developers are seeking to improve upon PLUVICTO in at least three ways.
These include:
1. Dosimetry to enhance tumour uptake. PLUVICTO is far from Figure 38: Data from mouse models of prostate cancer indicate that
ideal in terms of its dosing regimen. As the drug is based on a twice the amount of 67Cu-SARbisPSMA is taken up by tumours
small molecule targeting agent, its elimination via the kidneys compared to PLUVICTO (PSMA-617).
is rapid. Potent doses are required over a 36-week treatment
phase to ensure sufficient tumour uptake to elicit responses.
POINT Biopharma’s PNT2002 product supports similar mean
absorbed tumour doses to PLUVICTO at 5.8 Gy/GBq with
much inter-patient variability in dosimetry65.
67Cu-SARbisPSMA’s bivalency, again, may improve tumour

uptake based on initial preclinical data. Figure 38 shows that in
a mouse xenograft model 67Cu-SARbisPSMA take-up was
twice that of PLUVICTO at 1- and 24-hour time points.
2. Dosimetry to reduce off-target activity. Physiological

expression of PSMA in kidney, salivary glands and other
tissues leads to off-target drug activity and potential side
effects.
At this stage it seems unlikely that 67Cu-SARbisPSMA’s

biodistribution will differ materially from other small molecule
radioligands in development to affect this issue. Source: Benesova (2015)64, Zia (2019)49, Clarity.
3. Indication expansion. PLUVICTO is approved as a ‘salvage’ therapy, indicated for the treatment of adult
patients who have already been treated with other anticancer treatments (androgen receptor pathway
inhibitors and taxane-based chemotherapy). Developers are attempting to access higher lines of therapy (e.g.
pre-chemotherapy) and different subsets of disease (e.g. hormone sensitive prostate cancer or those whose
tumours have particular genetic mutations including BRCA-1/2). Developers are addressing this by: a)
conducting clinical trials in earlier stage patients (Novartis, Telix and POINT Biopharma all conducting Phase III
trials in ‘second line’ mCRPC treatment); and/or b) developing ‘alpha-emitting’ alternatives to the beta-
emissions associated with 177Lu. Novartis, Telix and POINT Biopharma have pre-clinical and Phase I trial
activity exploring the use of 225Ac-labeled agents.
Clarity’s 67Cu-SARbisPSMA clinical program is likely to focus also on these higher lines of therapy (1st and 2nd
line) akin to their development peers should initial efficacy in a similar ‘salvage’ population be demonstrated in
their Phase I/IIa SECuRE trial.
62 Hofman, M. S., et al. (2018) 177Lu-PSMA-617 radionuclide treatment in patients with metastatic castration-resistant prostate cancer (LuPSMA trial): a single-centre, single-
arm, phase 2 study Lancet Oncology 6: 825 – 833.
63 Jeitner, T. M. et al. (2022) Advances in PSMA theranostics Translational Oncology 22: 101450.
64 Benesova, M. et al. (2015) Preclinical evaluation of a tailor-made DOTA-conjugated PSMA inhibitor with optimized linker moiety for imaging and endoradiotherapy of
prostate cancer J Nucl Med. 56(6):914-20.

65 Schichardt, C. et al. (2021) Prostate-specific membrane antigen radioligand therapy using 177Lu-PSMA I&T and 177Lu-PSMA-617 in patients with metastatic castration
resistant prostate cancer: comparison of safety, biodistribution and dosimetry J. Nucl. Med. 10.2967/jnumed.121.262713

Figure 39: Selected radioligand agents in clinical development for prostate cancer
Agent Sponsor Status Dosing regimen Efficacy Clinical trial no.
Dosimetry phase is completed, with an SECuRE

67Cu- Clarity No data. First therapy patient
Phase I/IIa intention to define a recommended dose NCT04868604
SARbisPSMA Pharmaceuticals expected Q322.
(2 doses) of 67Cu SAR-bisPSMA.
Patients randomized to receive 7.4 GBq Median OS 15.3 months.

(+/- 10%) 177Lu-PSMA-617
PLUVICTO Confirmed OS benefit of +4 VISION
Novartis Approved intravenously every 6 weeks (+/- 1 week)
177Lu-PSMA-617
for a maximum of 6 cycles. months v SOC. NCT03511664
[44.4 GBq over 36 weeks] Response rate 45-55%.
To be determined. Current Phase I

primary objective is to establish a
recommended Phase II dose. In the Response rate >60% in
AcTION study patients with castrate patients refractory to 177Lu-
levels of testosterone that have received PSMA-617. AcTION
225Ac-PSMA-617 Novartis Phase I prior cytotoxic chemotherapy and/or
novel androgen axis drugs will receive a ≥90% decline in serum PSA in NCT04597411
dose of 225Ac-PSMA-617 via intravenous 82% of patients including
injection no more frequently than every 8 41% with undetectable PSA66.
weeks (+/- 1 week) for no more than 6
cycles.
Response rates 40-60% in

Patients randomized to receive 6.8 GBq early studies. SPLASH
PNT2002 Phase III (±10%) of 177Lu-PNT2002 every 8 weeks
POINTBiopharma for 4 cycles. Median PFS 4 months; Median NCT04868604
177Lu-PSMA-I&T
OS 13 months67.
[27.2 GBq over 32 weeks]
Patients randomised to receive 2 single

intravenous (IV) injections of 76 mCi each
(equivalent to a 45 mCi/m2 dose in a Median OS between 11.9 and
TLX591 standard 1.7m2 individual) of 177Lu-
Telix 42.3 months using single- and PROSTACT
177Lu- Phase III DOTA- rosopatamab, given 14 days
Pharmaceuticals fractionated-dosing NCT04876651
rosopatamab apart. strategies68.
[5.6 GBq over 2 weeks]
No data.
Target indications include: a)
TLX592 Telix First-in-human study uses 64Cu-TLX592 very early stage, recurrent, CUPID
Phase I
225Ac-RADmAb Pharmaceuticals for dosimetry and biodistribution. metastatic disease; and b) very NCT04726033
late stage after treatment
failure with PLUVICTO.
131I-1095 will be administered Response rates up to 70%

intravenously at 100 mCi for the initial with a single cycle but
therapeutic dose, and up to 3 additional subsequent cycles do not
ARROW
131I-MIP-1095 Lantheus Phase II dose(s) at 75 mCi or 100 mCi each, improve. Relapses common.
administered at least 8 weeks apart as NCT03939689
Haematologic toxicities likely
determined by dosimetry evaluation and due to high energy -particles
occurrence of dose-limiting events. from 131I69.
66 Sathekge, M., et al. (2019) 225Ac-PSMA-617 in chemotherapy naïve patients with advanced prostate cancer: a pilot study Eur. J. Nuc. Med. Mol. Imaging 46: 129 – 138.
67 Heck, M. M. et al. (2019) Treatment outcome, toxicity and predictive factors for radioligand therapy with 177Lu-PSMA-I&T in metastatic castration-resistant prostate cancer
Eur. Urol. 75: 920 – 926.
68 Sun, M. et al. (2021) Prostate-specific membrane antigen (PSMA)-targeted radionuclide therapies for prostate cancer Current Oncology Reports 23: 59.
69 Afshar-Oromieh, A. et al. (2017) Repeated PSMA targeting radioligand therapy of metastatic prostate cancer with 131I-IMP-1095 Eur. J. Nucl. Med. Mol. Imaging 44: 950 –
959.

Animal studies demonstrate good tumour uptake and dose-dependent tumour growth inhibition. Pre-clinical data is
published based on the LNCaP tumour xenograft mouse model of prostate cancer. Figure 40a shows how ascending
radiation doses of 67Cu-CuSARbisPSMA hold tumour size in check for longer periods of time. The administration of two
cycles of 15 MBq of activity resulted in similar tumor growth inhibition to a single 30 MBq administration, albeit there
was a trend for prolonged tumor growth inhibition in the fractionated dose group. Figure 40b indicates that the
fractionated, higher dose also produced better survival (50% at three months).
Figure 40: (A) Antitumor efficacy of 67Cu-CuSarbisPSMA against LNCaP tumor xenografts, expressed as average tumor size (±SEM) (n=5). (B)
Kaplan–Meier curve of percentage survival data; endpoint represents day on which tumor size was at least 1,200 mm3 or censoring occurred
(day 85).
Source: McInnes (2021).50
A2.3.5 Clinical development status of Clarity’s assets
Clarity is conducting a Phase I/IIA clinical trial named SECuRE under an approved Investigational New Drug (IND)
application in USA. The SECuRE study investigates both diagnostic PET (using 64Cu-SARbisPSMA) and therapeutic
utility aspects of the asset (using 67Cu-SARbisPSMA). Preliminary PET scan images have been released and provided
below in Figure 41. The time course of images show that tumour-associated radiotracer remains in situ for at least 72
hours post injection. Non-specific, extraprostatic take-up (e.g. salivary glands, kidney) fades over time.
Figure 41: PET scans in a patient with metastatic castrate-resistant prostate cancer imaged over multiple timepoints between 1 and 72 hours
post administration of 64Cu SAR-bisPSMA.

Clinical trials and data catalysts. Three clinical trials including SECuRE are either underway or scheduled. We have
summarized the studies below in Figure 42. All trials are in early stages (Phase I to I/IIa) with the majority focused on
investigation of Clarity’s diagnostic PET agent (using 64Cu-SARbisPSMA). Only the SECuRE trial investigates the
therapeutic utility aspects of the asset (using 67Cu-SARbisPSMA).
Readout in 2022 will provide definition of dosing characteristics for registration studies using 64Cu-SARbisPSMA. In 4Q
2022, PROPELLER will provide the first diagnostic performance assessment (sensitivity and specificity) measured in
human subjects with known or suspected primary prostate cancer. The study also incorporates a variable dosing element
to assess image quality as a function of radioactive dosimetry and versus a standard of care comparator (68Ga-PSMA11).
These data may become available concurrently with the first portion of SECURE, which looks prospectively at dosimetry
over 48-hours post administration. Note that Clarity’s biochemical recurrence diagnostic trial (COBRA) is administering a
single 200 MBq dose for imaging purposes. Data from this study should be available mid-2023.
Figure 42: Clarity’s trial program with 64/67Cu-SARbisPSMA
Agent, setting and Clinical trial

Study Phase n Objectives Exp. completion
trial design no.
Primary outcomes: a) safety and tolerability; b)

64Cu SAR-bisPSMA efficacy in the detection of primary prostate
cancer compared to histopathology (11 weeks). Recruitment completion
Diagnostic agent in Efficacy measured by the proportion of 64Cu-
pre-prostatectomy expected Q322.
SAR-bisPSMA PET/CT scans assessed as true NCT04839367
PROPELLER setting. I 30 positive or false negative. Top line data expected
Multicentre, blinded Q4 2022.
Secondary outcomes: a) comparison of image
review, dose-ranging, quality at varying dose levels (100 MBq, 150
non-randomised. MBq and 200 MBq); b) comparison of image
quality versus 68Ga-PSMA11 (standard of care).
64Cu SAR-bisPSMA Primary outcomes: a) safety: Incidence and First patient dosed April
Diagnostic agent in severity of treatment-emergent adverse events 2022. Targeting 50%
biochemical recurrent at 7 days; b) proportion of true positive recruitment in 3Q 2022.
COBRA I/II 50 NCT05249127
(BCR) prostate cancer. participants on the Day 0 & 1 scans; c) region-
level positive predictive value; d) proportion of Primary completion
Multicentre, single arm, date: Q2 2023.
non-randomised. true positive regions on the Day 0 & 1 scans.
64Cu SAR-bisPSMA
Primary outcomes: a) biodistribution and
67Cu SAR-bisPSMA dosimetry of 64Cu SAR-bisPSMA at 48 hours; b) Dosimetry phase for
Theranostic agent in maximum tolerated dose of 67Cu SAR-bisPSMA diagnosis is completed.
metastatic castrate- at 8 weeks; c) recommended dose (2 doses) of
I/IIa 67Cu SAR-bisPSMA at 14 weeks; d) efficacy of
First therapy patient NCT04868604
SECURE resistant prostate 34 expected Q322.
67Cu-SAR-bisPSMA as (≥50% decline in
cancer (mCRPC).
prostate specific antigen response and Top-line data on
Multicentre, single-arm, therapeutic component
radiographic responses up to 5 years post-
dose escalation with in Q3 2026.
treatment); and f) safety and tolerability
cohort expansion for up
assessments for both agents.
to 44 patients.
Phase III considerations for 64Cu-SARbisPSMA. Clarity’s PROPELLER (pre-prostatectomy) and COBRA (biochemical
recurrence) studies both investigate (secondary) efficacy endpoints we associate with pivotal trials and provide guidance
for Phase III trials. Looking more broadly for trial design predicates, the Lantheus/Progenics Phase II/III campaign for
PYLARIFY is the best available. The design features for the OSPREY70 (primary staging, pre-prostatectomy) and
CONDOR71 (biochemical recurrence) are provided in Figure 43, overleaf and best represent our current thinking about
Clarity’s future 64Cu-SARbisPSMA Phase IIIs.
70 Pouliot, F., et al. (2020) A prospective phase II/III multicenter study of PSMA-targeted 18F-DCFPyL PET/CT imaging in patients with prostate cancer (OSPREY): A sub-
analysis of regional and distant metastases detection rates at initial staging by 18F-DCFPyL PET/CT. J. Clin. Oncol. 38: 9.
71 Morris, M. J., et al. (2021) Diagnostic performance of 18F-DCFPyL-PET/CT in men with biochemically recurrent prostate cancer: results from the CONDOR Phase III
multicenter study Clin. Cancer Res. 27: 3674 – 3682.

Figure 43: Design features for Lantheus/Progenics PYLARIFY Phase II/III trials
Study OSPREY CONDOR
NCT03739684
Trial ID NCT02981368
Phase II/III III
Actual
385 208
enrolment
Evaluate the safety and diagnostic performance of 18F- Evaluate the diagnostic performance and safety of 18F-DCFPyL PET/CT
Brief
DCFPyL injection in patients with high risk prostate cancer imaging in patients with suspected recurrence of prostate cancer who have
summary
who are planned for radical prostatectomy (Cohort A). negative or equivocal findings on conventional imaging.
Design Single group assignment, open label. Single group assignment, open label.
• Specificity of 18F-DCFPyL PET imaging to detect metastatic

• Correct localisation rate (percentage of participants with a one-to-one
prostate cancer within the pelvic lymph nodes relative to
correspondence between localisation of at least one lesion identified on 18F-
Primary histopathology in high risk prostate cancer patients.
DCFPyL PET and the composite truth standard.
endpoint • Sensitivity of 18F-DCFPyL PET imaging to detect metastatic
• Within 60 days of PET either biopsy/surgery, conventional imaging or
prostate cancer within the pelvic lymph nodes relative to
locoregional therapy of the suspected lesions was performed.
histopathology in high risk prostate cancer patients.
• Histologically confirmed adenocarcinoma of the prostate.

• Histologically confirmed adenocarcinoma of the prostate. • Suspected recurrence based on rising PSA after definitive therapy on the basis
Inclusion • High risk disease defined as clinical stage ≥T3a or PSA > 20 of: a) post-radical prostatectomy with rising PSA ≥ 0.2 ng/ML; or post-radiation
ng/mL or Gleason score ≥ 8. therapy, cryotherapy or brachytherapy where PSA is ≥ 2 ng/mL above the nadir.
criteria
• Scheduled or planned radical prostatectomy. • Negative or equivocal finding on conventional imaging
• Life expectancy ≥ 6 months
• Subjects administered any high energy gamma-emitting isotope • Subjects administered any high energy gamma-emitting isotope within 5
within 5 physical half-lives or any IV contrast medium within 24 physical half-lives
Exclusion hours or any high-density oral contrast medium within 5 days of • Ongoing treatment with systemic therapy (ADT, anti-androgen, GnRH, LHRH
18F-DCFPyL injection. agonist or antagonist)
criteria
• Patients with prior androgen deprivation therapy or any • Treatment with ADT in past 3 months
investigational neoadjuvant agent or intervention. • Receipt of investigational therapy for prostate cancer in last 60 days
PSA = prostate specific antigen; ADT = androgen deprivation therapy; GnRH = gonadotropin-releasing hormone; LHRH = lutenizing hormone-releasing hormone
Source: clinicaltrials.gov, Wilsons.
Alternative trial campaigns are available but not reviewed in detail here. Blue Earth Diagnostics has completed two
Phase III trials testing its 18F-rhPSMA-7.3 asset. Novartis is conducting two Phase III trials for an agent licensed from
UCSF named 18F-CTT1057. In primary staging, Blue Earth’s LIGHTHOUSE72 (n = 356) and Novartis’ GUIDEVIEW73
(n=195) trials assess sensitivity and specificity compared to histopathology. In biochemical recurrence, Blue Earth’s
SPOTLIGHT74 (n=391) and Novartis’ GUIDEPATH75 (n=191) assess positive predictive value and correct localization
rates as primary endpoints.
72 https://www.clinicaltrials.gov/ct2/show/NCT04186819

 A.2.4 GRPr-positive prostate cancer
A2.4.1 Industry overview & standard of care
PSMA PET is unequivocally the new standard of care in prostate cancer diagnosis and assessment– all other modalities
are secondary now. The commercial availability of Lantheus’ PYLARIFY, Telix Pharmaceuticals’ ILLUCCIX and Novartis’
LOCAMETZ is likely to change the way prostate cancer is staged and managed. As a molecular imaging target, PSMA
eclipsed everything else in development, including GRPr. Possible reasons include: a) PSMA’s near ubiquity in prostate
cancer (expressed on 90-95% of primary lesions76); b) well defined physiologic expression in other tissues giving low
‘off-target’ imaging signals; c) few (if any) biological consequences of direct PSMA inhibition, in terms of safety.
The bombesin-GRPr77 interaction may play two complimentary roles in prostate cancer assessment. Imaging prostate
cancer patients with radiolabeled bombesin-like peptides started in the 2000s78 and pre-dates the development of
PSMA PET antagonists79. GRPr is overexpressed in 63–100% of primary prostate cancers but in a heterogeneous,
dynamic and stage-dependent manner, complicating its use as a diagnostic tool80. After more than 20 years of research
this picture is frustratingly incomplete. GRPr expression levels appear to be highest in low grade, earlier stage
tumours81. This is further evidenced by an inverse relationship between GRPr expression and Gleason scores (commonly
used prostate cancer grading system)82. In contrast, high grade prostate cancer, castrate-resistant subtypes and bone
metastases are associated with lower GRPr expression83. Ostensibly this complicates the development of GRPr-directed
clinical diagnostic and assessment tools. There are two potential roles that GRPr may play in prostate cancer diagnosis
and management including:
• Characterisation of early stage prostate cancer, possibly applied to biopsy. In primary staging, Figure 44: 68Ga-PSMA11 scan (top) fails
the use of PSMA-directed PET is already controversial for low risk patients. Given that PSMA to identify PSMA-negative, GRPr-
and GRPr are similarly ubiquitous, a specific, GRPr-directed PET scan may not add very much positive tumour, correctly identified by
useful information. There is evidence that changes in GRPr expression may give important clues 64Cu-SARbombesin PET scan (bottom).
in relation to the differentiation of prostate cancer (increasing tumour grade, development of
castrate-resistance). These insights may be better suited to improving biopsy interpretation in
newly diagnosed patients84.
• Assessing biochemical recurrence in PSMA-negative patients. Although GRPr expression is

lower in metastatic and high-grade disease, early studies suggest it is still good enough to
produce a PET image (Figure 44). Furthermore, GRPr-directed agents may also provide a means
of detecting PSMA-negative tumour progression and treating it with modalities including
theranostic radioligands. Other groups have developed bispecific agents imaging GRPr and
PSMA simultaneously85, however data suggested that the design of a dual binding PSMA motif
may affect tumour uptake and hence compromises diagnostic and therapy efficacy.
A2.4.2 SAR-BBN Design and Rationale
The design challenges of GRPr-directed PET/CT. Last year a comprehensive, systematic review of non-
PSMA prostate cancer theranostics was published. It summarized all previous clinical trials using GRPr-
directed PET agents conducted between 2013 and 2021. The vast majority of these agents were
academic in origin and featured the short half-life 68Ga isotope. Per patient positivity rates ranged
between 31% and 93% but the studies were small (between 4 and 50 patients) and involved
heterogeneous groups of subjects across both staging and recurrence settings. GRPr is expressed
physiologically in the pancreas so radiotracer take-up is very high in this organ. Whilst radiotracers are
ultimately cleared from the pancreas, this process doesn’t occur fast enough, particularly when imaging
with 68Ga (short half-life, losing half of its imaging activity every hour), creating challenges in obtaining a
clean image set.
Source: Clarity Pharmaceuticals
76 Budäus, L., et al. (2016) Initial experience of 68Ga-PSMA PET/CT imaging in high risk prostate cancer patients prior to radical prostatectomy Eur. Urol. 69: 393 – 396.
77 GRPR = gastrin-releasing peptide receptor
78 Wang, G., et al. (2022) 68Ga-labeled [Leu13Thz14]bombesin derivatives: promising GRPR-targeting PET tracers with low pancreas uptake Molecules 27: 3777.
79 Mansi, R., et al. (2016) Bombesin-targeted PET of prostate cancer J. Nucl. Med. 57: 67S-72S.
80 Faviana, P., et al. (2021) Gastrin-releasing peptide receptor in low grade prostate cancer: can it be a better predictor than prostate-specific membrane antigen? Front. Oncol.
11: 650249
81 Beer, M. et al. (2012) Profiling gastrin-releasing peptide receptor in prostate tissues: Clinical implications and molecular correlates. Prostate 72: 318–325.
82 Markwalder R., et al. (1999) Gastrin-releasing peptide receptors in the human prostate: relation to neoplastic transformation. Cancer Res. 59:1152–1159.
83 Ananias, H. J., et al. (2009) Expression of the gastrin-releasing peptide receptor, the prostate stem cell antigen and the prostate-specific membrane antigen in lymph node
and bone metastases in cancer. Prostate 69: 1101 – 1108.

84 Qiao, J., et al. (2016) Activation of GRP/GRP-R signaling contributes to castration-resistant prostate cancer progression Oncotarget 7: 61955 – 69.
85 Mitran, B., et al. (2019) Bispecific GRPr-antagonistic anti-PSMA/GRPr heterodimer for PET and SPECT diagnostic imaging of prostate cancer Cancers (Basel) 11: 1371.

Clarity set out to develop a 64Cu-based GRPr radiotracer that would retain its imaging power long enough for non-
tumour take-up to clear; whilst also allowing longer-lived retention by GRPr-positive tumours, and thus
circumnavigating this challenge. We await first clinical data to demonstrate they have achieved this.
Akin to Clarity’s other prostate program, SAR-BBN is a theranostic agent that can be used diagnostically or
therapeutically by substituting copper isotope. Clarity’s bombesin (BBN) based agent features a copper isotope, ‘caged’
within the ‘MeCOSar’ sarcophagine structure (Figure 45). This is conjugated to very potent GRPr antagonist
manufactured as a synthetic peptide. Pre-clinical work in mice xenograft models demonstrated high tumour take-up and
retention, rapid clearance from the pancreas and low liver uptake86. Investigation with the therapeutic 67Cu-bearing
variant in mouse models of prostate cancer showed favourable uptake, biodistribution and tumour inhibition87. Clarity’s
64Cu-SAR-BBN has received IND clearance from the FDA and plans to commence the first trial – SABRE (in PSMA-
negative prostate cancer patients) in 2H CY22. Clarity is planning an additional Investigational New Drug (IND)
application for 67Cu-SAR-BBN in prostate cancer.
Figure 45: General structure of [64/67Cu]Cu-SAR-BBN.
Source: McInnes (2021)88, Wilsons
No clinical data in prostate indication for 64/67CuSAR-BBN to date. To date Clarity’s 64Cu-SAR-BBN agent has been
evaluated clinically in metastatic HR+/HER2- breast cancer (C-BOBCAT study) with first-in-human safety data obtained.
This trial is reviewed in Appendix A2.5 overleaf. No data has been obtained in any prostate cancer populations as of yet,
with trial initiations planned for 2022.
86 Gourni, E., et al. (2015) Copper-64 labeled macrobicyclic sarcophagine coupled to a GRP receptor antagonist shows great promise for PET imaging of prostate cancer Mol.
Pharm. 10.1021/mp500671j
87 Huynh, T. T., et al. (2022) Copper-67-labeled bombesin peptide for targeted radionuclide therapy of prostate cancer Pharmaceuticals 15: 728.
88 McInnes, L. E. et al. (2021) Therapeutic efficacy of a bivalent inhibitor of prostate-specific membrane antigen labeled with copper-67 J. Nuc. Med.
Doi:10.2967/jnumed.120.251579.

 A2.5 Breast cancer
The type of breast cancer has a marked impact on prognosis, therapy response, and relapse rates. Breast cancer is highly
heterogenous, and according to different molecular characteristics is divided in into five basic subtypes (luminal A,
luminal B, HER2-enriched, basal-like, and normal-like). Luminal A/Hormone receptor (HR) positive, human epithelial
growth factor receptor 2 (HER2) negative (HR+/HER2-) breast cancer is the most common subtype accounting for ~70%
of all breast cancers89.90 In the US population this equates to 188,000 HR+/HER2- diagnoses per year.
Subtypes markedly affect prognosis and treatment. Knowledge of receptor expression profiles of primary breast tumors
but also potential metastases throughout the body, are important for both therapeutic and prognostic purposes. It is well
known that the expression levels may switch in time (estrogen receptor [ER], progesterone receptors [PR], HER2), e.g., a
metastasis without any receptor overexpression in the beginning may become positive within the next months or years
and vice versa. The important receptors, for which targeted therapeutic drugs and molecular imaging techniques are
available, are the estrogen receptor (ER), HER2 and the androgen receptor (AR).
A2.5.2 Diagnosis
Oncologists often have to consider a number of factors when choosing the best diagnostic process. The method chosen
has to account for a) providing the most comprehensive overview of a patient’s status b) sparing time and resources and
c) aiming to promptly start the most appropriate treatment. There is currently no single imaging modality able to do this
and thus the best approach has been derived from the combination of different techniques which most typically includes
18FDG PET/CT, bone imaging and diagnostic CT91. In clinical practice, conventional imaging with mammography,
ultrasound (US) and breast MRI are commonly used for staging local disease extent, whereas whole-body CT, 18FDG
PET/CT and bone scans are useful in systemic staging.
The role of 18FDG PET/CT in staging, follow-up and therapy response assessment in breast cancer is well known and
widely adopted. The modality has showed an added value over conventional radiology for the evaluation of locoregional
and distant metastases, thus providing important information for planning surgical strategy and for correct design of
radiation therapy. For similar reasons, 18FDG PET/CT is also useful in re-staging and management of breast cancer.
18FDG PET/CT limitations. 18FDG PET/CT is not indicated in patients with clinical stage I breast cancer, since distant
metastases are rarely observed in this early-stage disease. Furthermore, 18FDG PET/CT cannot replace conventional
diagnostic approaches in the identification of primary tumors (i.e. mammogram, biopsy) because of the high number of
false positives and false negatives, especially in the presence of small lesions92. The low specificity of 18FDG represents
a limitation of its use immediately after surgery and/or radiotherapy, since the high uptake observed in sites of
infection/inflammation does not allow the exclusion of active disease93. There has also be some contention to its
sensitivity in the detection of axillary lymph nodes – an important factor in Luminal A breast cancer diagnosis99. Another
possible limitation of this imaging modality resides in the evaluation of bone metastases that usually show lower avidity
for 18FDG PET/CT, and therefore, bone scintigraphy should be added.
A2.5.3 SAR-Bombesin
Clarity’s GRPr targeting, SAR-BBN has been designed to address some limitations in 18FDG PET/CT in breast cancer.
The primary limitation that Clarity is currently addressing is the reduced sensitivity of 18FDG PET/CT in Luminal A breast
cancer. As previously noted, HR+/HER2- subtype is the most common form of breast cancer, of which GRPr is particularly
overexpressed in. Clarity designed their Phase I trial (C-BOBCAT1) on this basis, to assess the potential of 64Cu-SAR-
BBN in the re-staging of HR+/HER2- metastatic breast cancer, going head-to-head with current SOC (18FDG PET/CT,
bone scan and diagnostic CT).
C-BOBCAT: 64Cu-SAR-BBN in the breast cancer setting. Results from a first-in-human study were published recently94.
The trial evaluated the safety and feasibility of [64Cu] SAR-BBN as a theranostic tool in women with metastatic
HR+/HER2- breast cancer (Figure 47). In this section we summarise the key clinical characteristics of the product only
(bearing in mind this was only a small, Phase I trial). Seven patients were administered a single 200 MBq dose of 64Cu-
SAR-BBN with the intention of scanning them at 1, 3 and 24 hours later. Safety was good with no adverse events nor
89American Cancer Society. (2021). How Common Is Breast Cancer? Available: https://www.cancer.org/cancer/breast-cancer/about.html
90National Cancer Institute. (2020). Surveillance, Epidemiology, and End Results Program. Cancer Stat Facts: Cancer Stat Facts: Female Breast Cancer. Available:
https://seer.cancer.gov/statfacts/html/breast.html.
91American Cancer Society. (2021). Breast cancer. https://www.cancer.org/cancer/breast-cancer.html
92Assi et al. (2021). Diagnostic Performance of FDG-PET/CT Scan as Compared to US-Guided FNA in Prediction of Axillary Lymph Node Involvement in Breast Cancer
Patients. Frontiers in oncology, 11, 740336. https://doi.org/10.3389/fonc.2021.740336

93Choi et al (2012). Correlation between hormonal receptor status/human epidermal growth factor receptor 2 overexpression and 18F-FDG uptake in patients with breast
cancer. Journal of Nuclear Medicine. 53 (Suppl. 1), 1285.

94 Wong, K., et al. (2022) 64Cu-SAR-Bombesin PET-CT imaging in the staging of estrogen/progesterone receptor positive, HER2 negative metastatic breast cancer patients:
safety, dosimetry and feasibility in a Phase I trial Pharmaceuticals 15: 772.

changes in haematological, biochemical or coagulation profiles between baseline and at 1 h post injection. The pancreas
demonstrated the highest uptake (as expected) but was cleared over 24 h. Clearance was similarly rapid from kidney
and liver. Dosimetry for the potential 67Cu-bearing therapeutic treatment was also assessed. Red bone marrow emerged
as the likely dose-limiting organ for therapy.
The C-BOBCAT trial demonstrated there may be clinical utility of SAR-BBN, particularly alongside 18FDG PET/CT, given
there were patients positive on SAR-BBN that were negative on 18FDG PET/CT and vice versa (Figure 46). The lack of
crossover potentially warrants the use of both imaging agents, however much larger studies are required to determine if
this phenomenon is maintained. SAR-BBN was demonstrated as especially useful in the lobular carcinoma subtype (ILC),
particularly important as 18FDG PET/CT has demonstrated lower intensity when imaging this subtype previously.
Figure 46: Images from Clarity’s C-BOBCAT study. Patient with lobular carcinoma subtype with large-volume bony, nodal and visceral disease.
FDG-PET scan was negative but positive on [64Cu]Cu-SAR-BBN-PET.
Source: Wong et al.94
Where to from here? It is likely that further trials of SAR-BBN in breast cancer will look to specifically address the
deficiencies currently seen in the ILC subtype. A larger trial could be conducted which, similarly to C-BOBCAT, compares
the efficacy of SAR-BBN vs. 18FDG PET/CT. The way in which SAR-BBN may be used for breast cancer in clinical
practice remains up for debate. If further trials are able to demonstrate their efficacy in the ILC subtype, we anticipate
that Clarity would seek to develop an accompanying therapy product, 67Cu-SAR-BBN, which would not only ensure that
there is adequate value in specifically identifying ILC, but will ensure their breast cancer program is of significantly higher
value. Whilst we do not incorporate the SAR-BBN breast cancer program in our valuation or forecasts currently, as more
data is gathered to define its position in breast cancer staging, we will look to reassess its value as further data comes to
light.

Appendix 3. Additional valuation and forecast detail

Below we outline the additional valuation and forecast detail for each of the seven Figure 47: Individual program valuation breakdown
individual programs, ranked in order of value according to Figure 47. ($0.82/sh)
$0.007 SAR-BBN Prostate
$0.03
Our overall SOTP’s valuation for Clarity is summarized in Section 3 (p.11-14). Cancer Tx
SAR-bis-PSMA
Our forecast assumptions for near-term programs are outlined in Section 4 (p.15- Prostate Tx
19). SAR-bis-PSMA
$0.09
Prostate Dx
$0.27
$0.10 SARTATE
Neuroblastoma Tx
 A3.1 Real-options valuations for Clarity’s individual programs $0.12

SARTATE
Neuroendocrine Dx
$0.21
A3.1.1 SAR-Bombesin Prostate Cancer Therapy (67Cu) SAR-BBN Prostate
Cancer Dx
SARTATE
Key points
Neuroblastoma Dx
Source: Wilsons.
• Risked present value of the option is $97.4m or $0.27 per share (unrisked:
$597.3m, $1.65 per share), representing an overall probability of 17% to
this project.
• Licensing transaction settled in 2028 after positive Phase II trial results with milestone payments up to
US$400m plus royalties (high-teen percentage of net sales). In NPV terms, Clarity’s royalties and milestone
payments are weighted 65:35. In NPV terms, Clarity’s share of overall asset cash flows is 37%.
Figure 48: ROV of Clarity’s SAR-Bombesin prostate therapy program

SAR-BBN Tx
Phase I/Phase II Partnering Phase III Approval/Access
Estimated probabilities (p) 50% 65% 65% 85%
Estimated timing 1/06/2025 1/06/2028 1/06/2032 1/12/2032
R&D costs (A$m) 12.0 - - -
S+ (upside values, A$m) 109.4143 285.5 587.9 1,334.2 1,569.7
S (start of phase value) 109.4 285.5 587.9 1334.2
Real option values (A$m) 97.4 285.5 587.9 1,334.2
Source: Wilsons.
A3.1.2 SAR-bisPSMA Prostate Cancer Therapy (67Cu)
Key points
• Risked present value of the option is $74.7m or $0.21 per share (unrisked: $350.0m, $0.96 per share),
representing an overall probability of 22% to this project.
• Licensing transaction settled in 2031 after positive Phase III trial results with milestone payments up to
US$435m plus royalties (low double-digit percentage of net sales). In NPV terms, Clarity’s royalties and
milestone payments are weighted 55:45. In NPV terms, Clarity’s share of overall asset cash flows is 30%.
Figure 49: ROV of Clarity’s SAR-bisPSMA therapy program

SAR-bisPSMA Tx
Phase I/II Phase II/III Partnering Approval/Access
R&D costs (A$m) 5.0 - - -
S+ (upside values, A$m) 79.74659 54.3 187.0 693.9 871.1
Real option values (A$m) 74.7 204.1 468.0 693.9
Source: Wilsons.

A3.1.3 SAR-bisPSMA Prostate Cancer Diagnostic (64Cu)
Key points
representing an overall probability of 30% to this project. We have assumed $43m in development costs.
Figure 50: ROV of Clarity’s SAR-bisPSMA diagnostic program

SAR-bisPSMA Dx
Phase I Phase II Phase III Approval/Access
R&D costs (A$m) 5.0 10.0 20.0 8.0
Source: Wilsons.
A3.1.4 SARTATE Neuroblastoma Therapy (67Cu)
Key points
• Risked present value of the option is $35.0m or $0.10 per share (unrisked: $144.8, $0.40 per share),
• Licensing transaction settled in 2024 after positive Phase I/II trial results with milestone payments up to
US$275m plus royalties (high-teen percentage of net sales). In NPV terms, Clarity’s royalties and milestone
payments are weighted 30:70. In NPV terms, Clarity’s share of overall asset cash flows is 40%.
Figure 51: ROV of Clarity’s SARTATE Neuroblastoma therapy program

SARTATE Neuroblastoma Tx
Phase I/II Partnering Phase II/III Approval/Access
R&D costs 1.5 - - -
S+ (upside values) 36.51383 60.8 88.6 164.2 215.5
Source: Wilsons.
A3.1.5 SARTATE Neuroendocrine Tumours (NETs) Diagnostic (64Cu)
Key points
• Licensing transaction settled in 2023 after positive Phase II trial results with milestone payments up to
US$200m plus royalties (low double-digit percentage of net sales). In NPV terms, Clarity’s royalties and
milestone payments are weighted 30:70. In NPV terms, Clarity’s share of overall asset cash flows is 35%.
Figure 52: ROV of Clarity’s SARTATE Neuroendocrine Tumour diagnostic program

SARTATE NETs
Phase II Partnering Phase III Approval/Access
R&D costs (A$m) 1.0 - - -
Source: Wilsons.

A3.1.6 SAR-Bombesin Prostate Cancer Diagnostic (64Cu)
Key points
• We have assumed $30m in specific development costs, noting that trials will be smaller due to targeting
~10% of the PSMA population.
Figure 53: ROV of Clarity’s SAR-Bombesin prostate diagnostic program

SAR-BBN Dx
Phase I/II Phase II/IIb Approval Access
R&D costs (A$m) 3.0 5.0 12.0 10.0
Source: Wilsons.
A3.1.7 SARTATE Neuroblastoma Diagnostic (64Cu)
Key points
• We have assumed $5.0m in specific development costs, given the small indication.
Figure 54: ROV of Clarity’s SARTATE Neuroblastoma diagnostic program

SARTATE Neuroblastoma Dx
Phase I/II Phase II/III Approval Market Access
R&D costs 1.0 2.0 0.5 1.5
S+ (upside values) 5.742511 7.7 11.8 15.6 18.0
Source: Wilsons.

 A3.2 Forecast assumptions
 A3.2.1 SARTATE
We have outlined forecast assumptions for the three SARTATE programs (neuroblastoma diagnosis, neuroblastoma
therapy and neuroendocrine tumour (NETs) diagnosis) in Section 4, p.15 given they are the most near-term
value/revenue generating prospects for Clarity.
Figure 55: Breakdown of PSMA-positive prostate cancer diagnostic market
 A3.2.2 SAR-bisPSMA
274K
A3.2.2.1 Diagnostic (64Cu) Total
Scans
37
We have outlined assumptions for this program on Section 4, p.16.
26 97 Initial Staging
We include further detail regarding the PSMA imaging market
breakdown in Figure 55. Based on 274K scans in 64Cu-SAR-
Presence of metastatic
bisPSMA’s peak sales year (FY31e), including the radioligand
disease
treatment-eligible population (which we have excluded in our
projected TAM for Clarity, given only certain agents are approved for Disease progression/
114 monitoring
pre-therapy), market share represents ~10% or ~27,000 scans per
annum. Radioligand treatment-
eligible
*Numbers presented in 000s.

A3.2.2.2 Therapy (67Cu) Source: Wilsons, Lantheus, Telix.
We detail forecast assumptions for 67Cu-SAR-bisPSMA in PSMA-positive Figure 56: 67Cu-SAR-bisPSMA market assumptions
prostate cancer, noting that anticipated launch year is FY32e and
represents a longer-term revenue opportunity. SAR-bisPSMA therapy
SAR-bisPSMA market assumptions
PSMA prostate cancer market dynamics. We model US peak sales of Anticipated launch year FY32
US$822m (FY36e) for SAR-bisPSMA in prostate cancer therapy which
Peak sales year FY36
assumes 12% share of the market (Figure 56). We expect there to be a
number of players in the targeted radiotherapy space and assess Clarity’s Peak sales amount (US$m) $822
offering as one of the options available. We see potential market share TAM (chemotherapy naïve, ADT switch
51,173
expansion if SAR-bisPMSA proves superior either clinically or logistically pts)
to their competitors, or, as treatment is offered in earlier stage Patients dosed 6,243
management. We note the recent halt to Novartis’ deployment of
Market share 12%
PLUVICTO, due to disruptions in the supply chain of 177Lu. We assess
that these issues may present as potential tailwinds for Clarity in the SAR-bisPSMA pricing assumptions $US pricing
future, as the development of 67Cu becomes more accessible and does Price per course of treatment $155,000
not rely on the use of nuclear reactors.
Gross to net discount ~15%
Pricing. We assess the US ASP of Clarity’s SAR-bisPSMA therapy Net price per course of treatment (US$) $131,750
program as a 40% discount to current PSMA targeted radiotherapy Pricing of on-market products PLUVICTO
(PLUVICTO) (Figure 56). The marked discount in pricing is a factor of a) Price per course of treatment $255,000
entering a potential multi-player market in FY32e and b) a means for
which Clarity can compete and adequately gain and take market share. Gross to net discount ~15%
We do not currently include any other jurisdictions in our SAR-bisPSMA Net price per course of treatment (US$)
$216,750
therapy forecast as too many uncertainties are present given the expected (excludes COGS)
partner licensing model. We see jurisdictional expansion (ex-US) as
SARTATE price comparison -40%
additional upside to our forecasts.
Source: Wilsons, Novartis.

 A3.2.3 SAR-Bombesin
We detail forecast assumptions for 64Cu-SAR-Bombesin and 67Cu-SAR-Bombesin in GRPr-positive prostate cancer
(PSMA-negative) diagnosis and therapy respectively. We view these programs as longer-term revenue opportunities.
Market share. We model global peak net sales of US$111m (FY34e) for SAR-BBN in prostate cancer diagnosis which
assumes 36% share of the PSMA-negative diagnostic market (Figure 57). For reference, 10-20% of prostate cancer
diagnoses are PSMA-negative95,96,97,98. We see good growth potential beyond this first market if value is found in
performing a dual assessment of both PSMA imaging and PSMA-negative imaging, particularly as the receptor that it
targets (GRPr) is found in >75% of prostate cancers and may be useful in recurrence detection. We also anticipate
further uptake of the SAR-BBN diagnostic if the accompanying SAR-BBN therapy is approved, given its use as a
predicate to therapy. We model US net sales of US$1,654m (FY37e) for SAR-BBN in prostate cancer therapy which
assumes 32% share of the market, noting that it is exclusively in the PSMA-negative indication (Figure 57). We see good
growth potential beyond the first market if practice suggests the utility of SAR-BBN beyond only the PSMA-negative
patients (~90%) and, it is used as an earlier stage treatment method.
Pricing. We assess the US ASP of Clarity’s SAR-BBN diagnostic program largely in line with current PSMA diagnostic
products (Figure 57). Given SAR-BBN will initially be used in the PSMA-negative cohort, SAR-BBN will likely enter the
market as a novel drug and hence is likely to receive similar pricing to PSMA diagnostic products (i.e. PYLARIFY) under
transitional pass-through (TPT) payment status. We have assumed a 15% discount to PYLARIFY for conservatism. We
estimate EU pricing as a ~60% discount to US pricing and retain a 10% gross to net discount. In terms of SAR-Bombesin
therapy, our US ASP per course is $200,000, with price per dose (assuming four doses based on neuroblastoma) at
$50,000. Akin to the diagnostic we reference current on-market products for our price assumptions (in this case
PLUVICTO), assuming a 20% discount to account for a) levelling out of PLUVICTO pricing as more players enter the
market and b) for SAR-BBN to be able to compete in not just the PSMA-negative population, but the PSMA-positive
population as well.
Figure 57: 67Cu and 64Cu-SAR-bisPSMA market assumptions

SAR-Bombesin Diagnostic SAR-Bombesin Therapy
SAR-Bombesin market assumptions
Anticipated launch year FY30 FY33
Peak sales year FY34 FY37
Peak sales amount (US$m) $111 $1,654
TAM (all pts) 521,608 N/A
TAM (PSMA-negative pts) 101,357 30,530
Patients dosed 35,372 9,846
Market share (all pts) 7% N/A
Market share (PSMA-negative) 35% 32%
SAR-Bombesin pricing assumptions $US pricing
Price per dose $4,100 Price per course of treatment (US$) $200,000
Gross to net discount 10% Gross to net discount ~15%
Net price per dose/scan (US$) $3,700 Net price per course of treatment (US$) $170,000
Pricing of on-market products PYLARIFY PLUVICTO
Price per dose/vial $4,900 Price per course of treatment (US$) $255,000
Gross to net discount ~10% Gross to net discount ~15%
Net price per dose/scan (US$) Net price per course of treatment (US$)
$4,500 $216,750
(excludes COGS) (excludes COGS)
SARTATE price comparison -15% -20%

Source: Wilsons, AA, Lantheus, Novartis.
95Afshar-Oromieh et al. 2017). Diagnostic performance of 68Ga-PSMA-11 (HBED-CC) PET/CT in patients with recurrent prostate cancer: evaluation in 1007 patients.
European journal of nuclear medicine and molecular imaging, 44(8), 1258-1268.
96Ferraro et al. (2020). Immunohistochemical PSMA expression patterns of primary prostate cancer tissue are associated with the detection rate of biochemical recurrence with
68Ga-PSMA-11-PET. Theranostics, 10(14), 6082.

97Baratto et al. (2021). PSMA-and GRPR-targeted PET: Results from 50 patients with biochemically recurrent prostate cancer. Journal of Nuclear Medicine, 62(11), 1545-
1549.
98Mapelli et al. (2022). 68Ga-PSMA and 68Ga-DOTA-RM2 PET/MRI in Recurrent Prostate Cancer: Diagnostic Performance and Association with Clinical and Histopathological
Data. Cancers, 14(2), 334.

Appendix 4: Copper isotope production

Prior to 2021, non-feasible methods to develop 67Cu stopped the translation of copper into clinical practice. The
potential of 64Cu/67Cu as an ideal theranostic isotope pairing has been hampered for decades by the inability to
effectively use copper leading to limited supply and low specific activity of 67Cu. Even five years ago, the industry’s
authoritative isotope and radiopharmaceutical sourcing document warned that “the difficult purification process and the
very low yields” meant that “doses of 67Cu are produced on a single animal or patient basis”. A calculation made at the
time showed that in absence of an improved process, a single patient dose of 67Cu could cost more than US$39,00099. In
2021, Clarity entered into an exclusive supply agreement with NorthStar Medical Isotopes for commercial supply of
67Cu. NorthStar (Beloit, Wisconsin) is emerging as the world’s first large scale source of 67Cu with high radionuclidic
purity and specific activity. This potential change in 67Cu availability is worth describing in a little more depth.
Traditional cyclotrons and particle accelerators create isotope ‘stews’ with low yields. Carrier-free100 67Cu can be
produced in small quantities by accelerating protons in a cyclotron or a linear accelerator (linac), directing the beam at
zinc ‘targets’ (Figure 58). Crudely, the collision of high energy protons with the nuclei of certain Zn nuclei causes an
elemental transition to Cu via the loss of one proton. Reasonable yields are only possible using the rare and expensive
isotope, 70Zn which loses one proton and two neutrons to form 67Cu. The energies required to optimize yield also limit
purity, causing the co-production of 64Cu and other side-reaction impurities that are difficult to remove from the 67Cu
product. There is no commercially feasible separation technology to extract 67Cu from a 67Cu/64Cu mixture. The only
approach is to allow enough time for the 64Cu contaminant to decay first (producing stable isotopes 64Ni, 64Zn).
Unfortunately, half the 67Cu produced is lost to decay, simultaneously101.
Figure 58: Cyclotrons use magnets to accelerate charged ions to sufficient energy to bombard a target material.
Source: Radiology Café.
The Argonne/NorthStar photonuclear approach. A major breakthrough was achieved by investigators at the Argonne
National Laboratory in Illinois by irradiating a highly enriched 68Zn (98.97%) target with high energy γ rays produced by
bremsstrahlung conversion102 of electrons from an electron accelerator103,104. Initially, this was performed using only
milligram quantities of 68Zn but now has been validated using larger ingots. In parallel, a collaboration between
NorthStar and IBA in Belgium has developed electron accelerators for commercial/clinical isotope supply (Rhodotrons®).
Both Argonne and NorthStar own granted US patents in relation to aspects of this 67Cu production technology (Figure
59).
Figure 59: Photonuclear production of 67Cu from a 68Zn target
Source: Wilsons.
99 Goethals, P-E. and Zimmermann, R. (2016) Nuclear Medicine World Market Report & Directory – Radionuclides, radiopharmaceuticals, market pipeline, R&D portfolio, market
data, product pricing, company profiles.
100 Carrier-free isotopes do not contain any contamination from the stable element. Thus carrier-free 67Cu contains no 63Cu or 65Cu (the two stable isotopes of copper).
101 Asabella, A. N. et al. (2014) The Copper Radioisotopes: A Systematic Review with Special Interest to 64Cu Biomed Res Int. doi: 10.1155/2014/786463.
102 Bremsstrahlung radiation is generated when an electron passes in the vicinity of the nucleus of an atom. The force of the nucleus deflects the electrons, and due to energy
conservation, the lost “braking” energy is emitted as a high-energy photon.

103 Stoner, J. et al. (2016) A comparison of DOTA and DiamSar chelates of high specific activity eLINAC produced 67Cu. J. Nucl. Med. 57, 1107.
104 Ehst, D. A. et al. (2012) Copper-67 production on electron linacs—photonuclear technology development. AIP Conf. Proc. 1509, 157–161.

Current 67Cu availability is limited. Argonne makes 67Cu commercially available but our channel checks suggest very
limited capacity with batches by appointment. The specific activity of Argonne’s 67Cu material is reported as 50 Ci/mg (a
10-fold improvement on cyclotron/linac-derived material). We understand that the 67Cu material Clarity is receiving from
Idaho State University’s Idaho Accelerator Unit has specific activity of 150 Ci/mg, rendering further improvements. IBA
has shipped two Rhodotrons to NorthStar, the first of which was activated earlier this year, in March (Figure 60).
NorthStar has a contract to acquire eight more Rhodotrons over the next five years to manufacture 67Cu, 225Ac and other
isotopes. We understand that 67Cu specific activities ranging from 180-550 Ci/mg may be possible105 with the planned
scheme that involves recycling of the recovered un-reacted target 68Zn and online mass separators. Achieving 100 Ci/mg
would put NorthStar’s 67Cu supply at a similar specific activity to the major source of clinical-grade, non-carrier-added
177Lu. EndolucinBeta® manufactured by ITM and supplied to Novartis for PLUVICTO manufacturing has specific activity
of at least 80 Ci/mg.
Figure 60: An IBA Rhodotron electron beam accelerator installed at NorthStar for the production of medical isotopes including 67Cu.
Source: NorthStar.
Industry feedback suggests that NorthStar likely has a year or more of commissioning and validation to work through
before they can produce material on these new accelerators. FDA has set no standards for 67Cu as a
radiopharmaceutical entity. NorthStar plans to prepare and file a Drug Master File (DMF) in the coming year but believes
it may take 5 years for the isotope to be established on international pharmacopeias. Clarity’s future approval filings for
67Cu-labelled agents (NDAs/BLAs) will reference NorthStar’s DMF.
Lutetium had the same limitations in manufacturing capability before it became the ‘chosen’ isotope for therapeutic
177
applications. Researchers note that less than 10 years ago there was only one reliable supplier for Lutetium – in 2022
there are an abundance (albeit a reliance on dated machines). With the advent of positive therapeutic trials which
demonstrate the utility of copper, facilities will likely be further incentivized to industrialise the 67Cu production process.
There are additional benefits to popularizing a cyclotron/accelerator method in comparison to the traditional nuclear
reactors. A huge amount of cost goes into 1) establishing a nuclear reactor facility, 2) dealing with the waste from the
nuclear reactors and 3) ensuring compliance to the added safety and environmental concerns. By comparison,
radionuclides produced by cyclotrons (64Cu) and accelerators (67Cu) are relatively less capital intensive, as it only requires
the establishment of a handful of facilities and have reduced waste products and impurities. We assess that Clarity will
establish two cyclotron facilities in the United States (likely East/West) which will be sufficient to supply the entire
market. It is difficult to assess the number of electron accelerator facilities required for the production of 67Cu, however
Clarity’s exclusive agreement with NorthStar will ensure the near-future availability of this product. We note the
establishment of Iotron Medical and TRIUMF, both set to produce 67Cu via electron accelerators via the same license
granted to NorthStar by Argonne Laboratories.
64Cu produced via enriched 64Ni, which can be recycled contributing to the cost-efficiencies. The target, 64Ni (~40mg), is
prepared and electroplated (coated with metal) onto a gold disk. 64Ni is bombarded on the cyclotron (for instance, IBA’s
Cyclone© IKON that accelerates protons from 13 to 30 MeV). After bombardment, the 64Cu is separated from the target
nickel (64Ni) in a one-step procedure using an ion exchange column. Typically, 18.5 GBq (500mCi) of 64Cu are produced
with a 40 mg 64Ni target and a bombardment time of 4 h (noting that newer machines, such as IBA’s IKON produce 30/Ci
per 5 hour run). Estimated costs of 64Ni based on ISOFLEX, San Francisco is ~$18/mg. Assessing the average dose of
64Cu in diagnostics as 5 mCi, the cost of 64Ni per dose is ~$70. The enriched 64Ni can be 85–95% recovered and can be
reused for future bombardments, which contributes to the cost-efficiency of the method.
105 NorthStar. Personal communication.

Reason for previously using 68Ga. There are both logistical and physiological reasons why 68Ga is a broadly used
diagnostic isotope. Logistically 68Ga has captured the nuclear medicine market despite the typically lower resolution of
PET images, because of its convenient and cost-effective manufacture via 68Ge/68Ga generators (without depending on
an onsite cyclotron facility). The consideration in production methods is summarized in Figure 61. Physiologically, it is
also a stable isotope that is not prone to ligand dissociation once inside cells, unlike previously used 64Cu. The issue
being that traditional 64Cu-based agents, once separated from its chelator, then translocates to the liver and the gut,
which is not seen with 68Ga based antibodies104. This has been solved with Clarity’s SAR technology.
Figure 61: Comparison of production methods for radioisotopes
Method of Number of machines in US (req.

Advantages Disadvantages Cost ($Am)
production for commercial use)
• Limited to 2 production runs per
• ~$150-180k for a • 500+
day
generator (based on • Currently insufficient to service
• Available to sites without a • Limit in volume of patient doses
EU pricing), replaced growing 68Ga market however difficult
Generator cyclotron (regional distribution) produced (to service a busy cancer
every 12 months to assess required number. Likely to
• Less up-front capital investment centre)
take ~5 years to service demand (with
• Potential delay in delivery of
continued rate of investment)
generator
• Requires nuclear pharmacist to run • 150-250

Cyclotron (i.e. • Easily produced in a cyclotron • Centralised production which may • ~$15m to establish a • 2 cyclotrons may be sufficient for
Rhodotron) • Large upfront capital investment affect distribution if employing a facility Clarity to service US
short half-life isotope (18F, 68Ga)
• Already established reactors do not

• High probability of accurate have capabilities to produce 177Lu • ~$600M (based on • No main nuclear reactor-based
production (1mg of Lu produces due to unique requirements the newly isotope suppliers are in the US.
Nuclear reactor 50+ doses) • ~10 suitable facilities worldwide constructed OPAL • There are 10 nuclear reactors
• Approval of 177Lu (LUTATHERA©, leading to supply limitations reactor in Australia in worldwide able to supply 177Lu
PLUVICTO©) has driven research • Produces waste which introduces 2007-2019) however 8 of these are >40 years old.
and advances in production safety and economic concerns
• Allows commercialisation of
Electron previously non-feasible isotopes • Newly developed technology that • ~$9m per machine
accelerator (67Cu) is not yet widely available (based on Rhodotron • ~8 machines currently in the US
• Establishment of this technology • Larger up-front capital invesment TT300 HE)
(Rhodotron)
has already been driven by need for
99Mo
Source: IBA, European Association of Nuclear Medicine, Nuclear Engineering International, Eckert & Ziegler.
Clarity’s novel sarcophagine chelators form complexes with both 67Cu and 64Cu that are extremely stable. It Figure 62: An illustration of
has been well demonstrated that generic ligands for radiopharmaceuticals (e.g. DOTA) do not form stable Clarity’s sarcophagine ‘cages’
linkages to copper, leading to copper leaking from the molecule and ultimately lodging in the liver106 where that hold copper (Cu) isotopes
unwanted toxicity may arise. Clarity have solved for this issue of copper leakage via modification of a known in a chemically stable configuration.
copper-chelating agent, a macrobicyclic hexamine cage ligand – sarcophagine (Figure 62). Clarity’s IP centres
around the development of novel chemistry that can stably keep copper isotopes bound once inside the body.
An example being a pendant carboxylic acid group that is able to be reliably attached to an amine on a
tumour-targeting peptide, such as SSTR2, creating their SARTATE asset. Clarity’s copper cage technology
stably contains both copper isotopes within the body to minimize non-specific toxicity and maximise imaging
clarity.
The synthesis of Clarity’s copper “cages” can be achieved with yields of up to 100% in a few minutes at room
temperature107. Clarity and its collaborators have developed a family of such molecules based on this core
structure. Various linker chemistries are available to suit a range of tumour-targeting binding groups including
small molecules, peptides or monoclonal antibodies108. Clarity’s prostate cancer theranostic 64/67Cu-SAR-
bisPSMA was selected from a family of such agents that target PSMA, bind serum albumin with a range of
affinities, and chelate radiometals.109
Source: Paterson (2014).104
106 Bass, L. A. et al. (2000) In vivo transchelation of copper-64 from TETA-octreotide to superoxide dismutase in rat liver Bioconjug. Chem. 11: 527 – 532.
107 Paterson, B. M. et al. (2014) PET imaging of tumours with a 64Cu labeled macrobicyclic cage amine ligand tethered to Try3-octreotate Dalton Trans. 43: 1386.
108 Kelly, J. M., et al. (2020) Preclinical evaluation of a high-affinity sarcophagine-containing PSMA ligand for 64Cu/67Cu-based theranostics in prostate cancer Mol.
Pharmaceutics 17: 1954−1962.

109 Kelly, J. M., et al. (2018) Trifunctional PSMA-targeting constructs for prostate cancer with unprecedented localization to LNCaP tumors. Eur. J. Nucl. Med. Mol. Imaging 45:
1841−51.

Appendix 5: Deals in the radiopharmaceutical sector

 A5.1 Rare disease designation and priority review voucher program
Clarity has received Rare Paediatric Disease Designations (RPDD) for its SARTATE™ program for both 64Cu SARTATE
for the management of NB and 67Cu SARTATE for the treatment of neuroblastoma. Figure 63 below outlines the
benefits of being granted a RPDD. Clarity has two products in development that may be eligible for one PRV each (a
total of two PRVs) if the products are approved by the FDA.
The US FDA defines a rare paediatric disease (RPD) as a serious or life-threatening disease primarily affecting individuals
aged 18 years or younger that impacts fewer than 200,000 people in the United States. The RPD program is intended to
facilitate development of new drugs and biologics for the prevention and treatment of RPDs. As part of this program, the
FDA provides various incentives including the potential for a Priority Review Voucher (PRV) to be awarded. Figure 64
highlights the amount paid by recent PRV transactions, representing further revenue opportunity for Clarity.
Figure 63: Benefits of rare paediatric disease designation for drug commercialisation outcomes
Elements Description Impact
< 200,000 patients in the United States or > 200,000

Rare disease The intent of the Orphan Drug act is to provide incentives for drug
patients but with no reasonable expectation that the
definition manufacturers to provide treatment for rare diseases.
cost of development will be recovered.
The market exclusivity for a new chemical entity in the United States is
Market Seven-year market exclusivity for sponsors of approved typically five years after FDA approval; for orphan drugs the FDA will not
exclusivity orphan drugs or products. award market authorization for a generic drug for the rare disease for seven
years post-approval, a substantial incentive of superior patent protection.
The Orphan Drug Tax Credit (ODTC) allows sponsors

who have orphan designation to collect tax credit, which The ODTC lowers the cost of drug development and is particularly beneficial to
Tax
is 25% of applicable costs, for expenses occurred smaller manufacturers, who without the credit, may not be able to continue
incentives
subsequent to issue of the designation for U.S. clinical their development programs for treatments for rare diseases.
trial costs on the orphan indication.
The grant program lowers the cost of drug development. According to the
Clinical Orphan Product Grant program provides funding for FDA, the Office of Orphan Products Development (OOPD) has received over
research clinical testing of new therapies to treat and/or diagnose 2,500 applications, reviewed over 2,200, funded over 660 studies and helped
subsidies rare diseases. 70 products gain marketing approval Receiving a grant from the Orphan
Product Grant program eases the likelihood of marketing authorization.
A PRV speeds up the timeline that the FDA commits to the review of a drug
application, which is significant for companies who seek to buy PRVs to
Priority review vouchers (PRVs) are granted for serious
Priority accelerate approvals and shorten the time to market (if ultimately approved)
conditions, usually affecting paediatric indications. The
review and thereby potentially boosting their sales.
drug review process is usually shortened to ~6 months.
PRVs are fully tradable and transferrable and can be either used by the receiving
company or sold to another drug developer.
Other Orphan drugs and products are exempt from the usual
These regulatory incentives lower the cost of drug development and enables
regulatory new drug application or "user" fees charged by FDA (i.e.,
therapies to reach patients sooner.
incentives PDUFA).
Source: FDA.
Figure 64: Recent priority review voucher sales average ~US$100m

Buyer Seller Date Amount (US$m)
Merck Lumons Pharma Jul 2020 $100m
Agenx Bayer Nov 2020 $98m
United Therapeutics mAbs Therapeutics Dec 2020 $105m
Alexion (AstraZeneca) Rhythm Pharmaceuticals Jan 2021 $100m
Undisclosed Albireo Pharma Sep 2021 $105m
Undisclosed Biomarin Pharmaceuticals Feb 2022 $110m
Novo Nordisk Marinus Pharmaceuticals July 2022 $110m
Average $104m
Source: Company statements.

 A5.2 M&A deals in the space
Figure 65 demonstrates the ongoing activity in the radiopharmaceutical market across the last 5-6 years.
Whilst the below represents a broad range of deals, it highlights the propensity for Pharma (e.g. Novartis)
to pay significantly larger amounts for later stage programs (note the ABX acquisition in 2017 followed by
Novartis subsequent acquisition of Endocyte a year later). We asses these deals as evidence of the ability
of Clarity to establish partnerships for their programs in SARTATE, SAR-bisPSMA and SAR-BBN.
Figure 65: Recent acquisition and licensing deals for radiopharmaceutical assets
Acquirer Company type Target Deal date Deal type Selected deal terms Project(s) included
Public $4m up front, $49m

Bayer Progenics Apr 2016 Exclusive license BAY 2315497
(ETR:BAYN) R&D milestones
$15m R&D
Fusion Pharma Private Immunogen Dec 2016 Exclusive license FPI-1434
milestones
LUTATHERA
Public Advanced Accelerator $3.9bn cash & stock 177Lu-PSMA-R2
Novartis Oct 2017 Acquisition
(NYSE:NVS) Applications acquisition 177Lu-NeoB
177Lu-FF-10158
Public ABX Biomedizinische $12m up front, $3.8m 177Lu-PSMA-617

Endocyte Oct 2017 Exclusive license
(NASDAQ:ECYT) Forschungsreagenzien stock & warrants 225Ac-PSMA-617
Public $2.1bn cash 177LuPSMA. 617

Novartis Endocyte Oct 2018 Acquisition
(NYSE:NVS) acquisition 225Ac-PSMA-617
University of FAPI-46
Sofie Private Jun 2019 Exclusive license Not disclosed
Heidelberg FAPI-74
Public 3B Pharmaceuticals
Clovis Oncology Sep 2019 Exclusive license $12m up front FAP-2286
(NASDAQ:CLVS) GmbH
$0.2m up front,
Asset acquisition & Undisclosed
Fusion Pharma Private Mediapharma May 2019 $1.5m R&D
exclusive license antibody
milestones
Lantheus Public $641m all-stock 1-131-1095
Progenics Oct 2019 Merger
Holdings (NASDAQ:LNTH) acquisition BAY 2315497
$3.5m & stock up
front; $22.5m stock &
Fusion Pharma Private Rainier Therapeutics Mar 2020 Asset acquisition R&D milestones; FP1-1966
assumption of $44m
milestones to Roche
Point Biopharma Private Scintomics GmbH Mar 2020 Asset acquisition Not disclosed PNT2001
Apr & Dec $0.6m & $0.2m up

Point Biopharma Private Bach Biosciences Exclusive license PNT2004
2020 front
Technische Universität
Point Biopharma Private Jun 2020 Exclusive license Not disclosed PNT2002
München
$0.3m up front,
Telix Public $16.2m stock, Scintium
Therapharm Nov 2020 Acquisition
Pharmaceuticals (ASX:TLX) $16.2M R&D 90Y-besileomab
milestones
Public Jun 2021
Point Biopharma Canprobe Jan 2021 Exclusive license $0.6m up front PNT2003
(NASDAQ: PNT)
Stock up front,
€67.5m R&D
Public assumption of €70m
Fusion Pharma Ipsen Mar 2021 Asset acquisition FPI-2059
(NASDAQ:FUSN) milestone to
undisclosed third
party
Public FAPI-46
Novartis Itheranostics (Sofie) Mar 2021 Asset acquisition Not disclosed
(NYSE:NVS) FAPI-74
Lantheus Public
Noria Therapeutics Mar 2021 Asset acquisition Not disclosed NTI-1309
Holdings (NASDAQ:LNTH)
Bayer Public Noria Therapeutics/ 225Ac
PSMA
June 2021 Acquisition Not disclosed
Pharmaceuticals (ETR:BAYN) PSMA Therapeutics compound
Source: Company statements, Refinitiv, S&P Capital IQ.

Appendix 6: Intellectual Property Summary

In this section we summarise Clarity’s patent portfolio (Figure 66), which is primarily concerned with protecting its lead
drug molecules in a composition of matter sense. We also identify protections relating to derivatives of those molecules
and synthetic chemical methods used in their production. Other patents prosecute ‘use claims’ relating to imaging and/or
treatment of cancers. Note that we have not conducted any explicit freedom to operate searches/assessments on any of
the patents owned or licensed by Clarity.
We note two core patent families with notional 2029 expiry dates. We have assumed a standard patent term of 20
years from filing date. These patents cover aspects of synthetic chemistry in the preparation of drug molecules. Other
longer-lived aspects of Clarity’s chemistry IP may apply to the same molecules or intermediates, thus extending their
protected status.
Importantly, Clarity’s lead molecules (SARTATE, SAR-BBN and SARbisPSMA) enjoy composition of matter claim
protection until 2037-2040 in most major market jurisdictions. Further, it is likely that all of Clarity’s imaging and
theranostic agents will be considered New Chemical Entities (NCEs). Defined as such, these molecules may be eligible
for 5 years of non-patent exclusivity from their date of FDA approval (under the Hatch-Waxman Act).
Figure 65. Patents owned or licensed by Clarity Pharmaceuticals

Patent family US Patents Notional US expiry International Patents Jurisdictions
1. Formulations for radiotherapy and diagnostic US-17164338-A1 November 2037 AU 2017354941 Granted: Australia
imaging (application)
WO2018/081860 Pending: Brazil, China,
Europe, Japan, Canada,
Russia
Claims aqueous formulations of SARTATE for parenteral administration complexed with copper ions
(including 64Cu and 67Cu).
The patent further claims processes for preparing such solutions and methods for using them in the
imaging, diagnosis or treatment of cancers.
2. Formulations and kits for radiotherapy and US-17042772 April 2039 WO2019/195890 Pending: Australia,
diagnostic imaging (application) Europe, China.
Claims aqueous formulations of precursor molecules used in the synthesis of Clarity’s sarcophagine
‘cages’. Specifically, these tetrazine-substituted ligands can undergo an inverse electron demand
Diels-Alder reaction to produce a click chemistry conjugate.
The patent further claims processes and kits for preparing such solutions and methods for using them
in the imaging, diagnosis or treatment of cancers.
3. Nitrogen-containing macrocyclic conjugates as US 10,870,664 December 2029 AU 2009322081 Granted: Australia,

radiopharmaceuticals Canada, China, Europe
US 10,301,326 CA 2745495
and Japan.
US 10,544,164 CN 200980156413.6
EP 2370447
EP 3098225
JP 9,701,694
Chemical methods for the synthesis of complex molecules containing macrocyclic metal ligands,
molecular recognition moieties and linkers. The patent provides and protects the ability to create
multimeric complexes. Provides composition of matter style claims over compounds and
intermediates for the synthesis of SAR-BBN, SARbisPSMA and SARTATE.
Source: WIPO, Wilsons.

4. Process for the preparation of asymmetrical US-13139476 December 2029 AU 2009326867 Granted: Australia,
bis(thiosemicarbazones) Canada, China,
US-14363219 CA 2746070
Europe, India and
(applications) CN 200980156755.8 Japan.
EP 2379493
IN 293406
JP 5,711,142
Novel chemical reaction methods for the production of bis(thiosemicarbazone) intermediates with a
wide variety of potential substituents. Allows for the straightforward commercial synthesis of
radiopharmaceuticals based on these structures.
5. Cage amine ligands for metallo- US 9457107 December 2032 AU 2012350147 Granted: Australia,
radiopharmaceuticals Japan.
US 9861714 JP 6,047,581
Pending: Europe.
Novel chemical synthesis methods for producing sexidentate cage structures without unwanted side
reactions; whilst allowing for the attachment of molecular recognition moieties.
6. Functionalisation of cage amine ligands for US 9364570 December 2032 AU 2012350146 Granted: Australia,
metallo-radiopharmaceuticals Europe, Japan.
EP 2788354
JP 6,051,227
WO2013/082655-A1
Novel chemical methods for attaching binding moieties to amino-substituted metal chelating
ligands/complexes.
7. Radiopharmaceuticals, radio-imaging agents US 10975089 June 2038 WO2018/223180-A1 Granted: Australia,

and uses thereof USA, Mexico, China
Pending: Japan,
Canada, Europe.
Patent describing and claiming chelated copper compounds that act as PSMA antagonists for
potential diagnostic and theranostic use. Scope of claims include 64Cu-SAR-PSMA monomer.
8. Targeting compounds and methods for their US-17046053-A1 April 2039 WO2019/195888 Pending: Australia,
production China, Europe
Additional composition of matter patent claims. This patent anticipates and claims ligands that target
an intermediate compound that initially binds to target site in vivo. Since the ligand typically contains
a radioisotope, its ability to react with a specific functional group, rather than a particular receptor
allows more specific localisation (less off-target binding in other tissues). In this sense the patent
protects a pre-targeting approach to radioimaging/treatment.
9. Formulations of PSMA imaging agents WO2020/237290 May 2040 WO2020/237290 Pending: Australia,
Canada, Korea, China,
Europe, Brazil, Japan,
Malaysia, Russia,
Singapore, India.
Patent claims composition of matter protection for 64/67Cu-SARbisPSMA and various derivatives of
that molecule.

10. Cryptate compounds US-14129855 July 2032 WO2013/003912 Pending: Australia,

Europe, Japan.
US-16900335
US-16900451
Ancillary, novel chemical methods and reactions providing access to more structures and derivatives,
this time involving cryptand and cryptate structures. Specifically, the chemistry involves the coupling of
cryptates with other functional groups via a carbonyl group. The reaction sequence may feature in
attaching linker molecules to core, metallo-organic complexes.
11. Radiolabelled targeting ligands AU 2019/904218 Provisional patent 6/11/2020 US
12. Radiopharmaceuticals, uses thereof and Provisional patent 14/8/2020 Australia

methods for the production thereof
13. Radiopharmaceuticals, methods for their Provisional patent 14/8/2020 Australia

production and uses in diagnosis and imaging
diseases
14. Cancer targeting compounds and methods for Provisional patent 29/9/2020 Australia
their production

Appendix 7: Board and Management

 A7.1 Board
Dr Alan Taylor. Executive chairperson. Dr Taylor joined Clarity’s Board as Executive Chairperson in 2013. Prior to joining
Clarity, Dr Taylor was an Executive Director of Inteq Limited, a boutique Australian investment bank, gaining 15 years of
experience. Following his undergraduate degree in Applied Science at the University of Sydney, Alan completed his PhD
in Medicine at the Garvan Institute of Medical Research. Dr Taylor has also completed a Graduate Diploma in Applied
Finance at the Securities Institute of Australia.
Dr Colin Biggin. Managing Director and CEO. Dr Biggin joined Clarity’s Board in October 2019 as Managing Director and
CEO after joining the Company in January 2017. Dr Biggin has over 15 years of radiopharmaceutical development and
commercialisation experience. Dr Biggin previously served with Algeta ASA during the development and
commercialisation of its product Xofigo® (radium-223 dichloride) for metastatic prostate cancer, which was approved by
the FDA in 2013, alongisde Bayer. Prior to joining the Company, Dr Biggin also consulted to a range of biotech and large
pharmaceutical companies developing radiopharmaceuticals. Dr Biggin holds a Bachelor of Science (Honours) and a PhD
from the University of Glasgow.
Robert Thomas. Lead Independent Director. Mr Thomas joined Clarity’s Board as an NED in August 2021, before being
recently appointed as Lead Independent Director (9 Jun 2022). He has more than 40 years of experience in the securities
industry including advisory roles on the IPOS of Commonwealth Bank of Australia and Qantas. He is chair of Starpharma
Holdings, Aus Bio and Grahger Retail Securities. Mr Thomas is also a director of O’Connell Street Associates, REVA
Medical, and Biotron. He was previously a director of Heartware International. Mr Thomas has a Bachelor of Economics
from Monash University. He has been a member of the Securities Institute of Australia since 1976and was appointed as
a Fellow to the Institute in 1997. He is a Master Stockbroker and a Fellow of the Institute of Company Directors.
Rosanne Robinson. Non-Executive Director. Ms Robinson joined Clarity’s Board in 2010. She brings extensive experience
in the nuclear field and a range of commercial expertise to the Company and has over 25 years of experience in both
governance and management roles in public and private companies. Ms Robinson is the current General Manager of
Business Development at Australian Nuclear Science and Technology Organisation (ANSTO). Ms Robinson holds a
Bachelor of Business (Accounting), a Graduate Diploma of Accounting (CA) and is a Graduate of the Australian Institute
of Company Directors.
Dr Chris Roberts. Non-Executive Director. Dr Roberts joined Clarity’s Board in 2016. He has over 40 years of experience
in the medical innovation space and has served on the boards of a number of ASX-listed companies during his career. Dr
Roberts was previously the CEO of ASX-listed company Cochlear Limited and Chairman of ASX-listed company Sirtex
Medical Ltd. Dr Roberts was also Executive Vice-President and a director of the dual-listed (ASX and NYSE) company
ResMed Inc. Dr Roberts holds a Bachelor of Engineering (Honours) in Chemical Engineering from the University of New
South Wales, an MBA from Macquarie University and a PhD from the University of New South Wales. He has also been
awarded Honorary Doctor of Science degrees from Macquarie University and the University of New South Wales.
Dr Thomas Ramdahl. Non-Executive Director. Dr Ramdahl joined Clarity’s Board in 2019. He is a pharmaceutical
executive with over 20 years of clinical and development experience. From 2001, he became President and the first CEO
of Algeta ASA, later serving in several senior positions within the company through to and post the acquisition of Algeta
by Bayer AG in 2014 for US$2.9 billion. Dr Ramdahl has authored more than 40 publications and is a co-inventor of
several patents. Dr Ramdahl currently serves as Chairman of Precirix (Belgium) and AppSens AS (Norway). Dr Ramdahl
gained his PhD in Environmental Chemistry from the University of Oslo and holds a Master of Science in Organic
Chemistry from the Norwegian Institute of Technology.
Dr Gillies O’Bryan-Tear. Non-Executive Director. Dr O’Bryan-Tear joined Clarity’s Board in 2019. He has over 30 years of
experience in the pharmaceutical industry in clinical development, medical management and commercial roles. He has
held senior leadership roles in large and small pharmaceutical and biotech companies in the US and Europe and has
been involved in multiple product approvals. He was previously the Chief Medical Officer of Algeta ASA. Dr O’Bryan-
Tear has been an adviser to several US and European biotech companies and is a member of the Scientific Advisory
Boards of Audentes, Inc. (US) and Fusion Pharmaceuticals Inc. (Canada). Dr O’Bryan-Tear obtained his Doctor of
Medicine degrees from the Universities of Cambridge and London and trained in internal medicine and oncology in the
United Kingdom.

 A7.2 Management
Dr Alan Taylor. Executive chairperson. As above.
Dr Colin Biggin. Managing Director and CEO. As above.
Dr Matt Harris. Chief Scientific Officer. Matt was part of the founding group, TM Ventures, former CEO (2014-2019) and
is currently Chief Scientific Officer of the Company. Matt has approximately 20 years of combined experience in cancer
research, nuclear medicine and business, holding leading managerial and director roles in several early stage Australian
life science companies. Matt brings expertise in developing the technology behind the Clarity’s products. Matt holds a
PhD in cancer research from the John Curtin School of Medical Research at Australian National University. He has also
obtained an MBA from the Australian Graduate School of Management.
Michelle Parker. Executive Vice President, Global Clinical Operations. Michelle joined the Company in June 2018 as the
Company’s Director of Clinical Operations. Michelle has over 20 years of experience spanning across nuclear
medicine/PET and pharmaceutical industries both in Australia and internationally. Prior to joining the Company, Michelle
held the position of Head of International Clinical Research Operations at Novartis Australia. Michelle holds a Bachelor of
Applied Science in Medical Radiation Technology (Nuclear Medicine) from the University of Sydney.
Dr Jennifer Rosenthal. Director of Quality and Regulatory Affairs. Jennifer joined the Company in October 2019 as the
Company’s Director of Quality and Regulatory Affairs. Jennifer has over 20 years of management experience in the
biotechnology industry, serving in senior director and executive level roles with an oncology focus. She has successfully
developed strategy, and managed teams and projects in the areas of regulatory affairs (agencies include US Food and
Drug Administration, European Medicines Agency and Australian Therapeutic Goods Administration), clinical trials,
quality assurance and intellectual property. Prior to joining the Company, Jennifer managed the global regulatory team at
the previously ASX-listed company Viralytics Limited, which was acquired by Merck & Co for $502 million in 2018. Prior
to Viralytics, Jennifer spent 10 years at Alchemia Limited, Jennifer holds a PhD in genetics and molecular biology from
Monash University.
Shaemus Gleason. Executive Vice President, Operations. Shaemus joined the Company in May 2021 as the Company’s
Executive Vice President of US Operations. Shaemus has over 13 years of experience spanning across all facets of
targeted radionuclide therapies and diagnostic radiopharmaceuticals. Prior to joining the Company, Shaemus was a
member of the oncology strategy business unit at Bayer/Algeta where he was responsible for the technical operations in
their phase I targeted alpha therapy development globally. Prior to this, he held a leadership role on the US commercial
organisation supporting Algeta’s (Bayer) Xofigo® (radium-223 dichloride) product for metastatic prostate cancer.
Shaemus holds a Bachelor of Science (Engineering) from the Colorado School of Mines.
David Green. Chief Financial Officer. David joined the Company in January 2022 as Clarity’s Chief Financial Officer
responsible for the overall financial management of the Company including IT and HR. David comes to the role with over
25 years’ experience insenior finance roles for listed and unlisted companies, including Pacific Dunlop Limited, Sigma
Pharmaceuticals, Alchemia Limited, Chiquita Brands South Pacific Limited (now Costa Group) and Ellume Limited. David
commenced his career with Ernst & Young in Australia and Europe. David is a Chartered Accountant and holds a
Bachelor of Economics (Monash University) and Masters of Applied Finance (Securities Institute of Australia).
Robert Vickery. Company Secretary. Robert joined the Company in July 2019 as Clarity’s Chief Financial Officer and is
now serving as Company Secretary. Robert is a finance and governance executive with over 30 years of experience and
has had extensive involvement in life sciences and early stage businesses. Prior to joining the Company, Robert led the
finance function at the previously ASX-listed company, Viralytics Limited, and was a key member in the trade sale
negotiations and due diligence process with the purchaser of the company Merck & Co. Robert is a Chartered Accountant
and holds a Bachelor of Commerce from the University of New South Wales. He also obtained a graduate diploma in
Corporate Governance.

 A7.3 Scientific Advisory Board
Professor Oliver Sartor. Professor Sartor is a medical oncologist and an internationally recognised expert in prostate
cancer. He is the Laborde Professor for Cancer Research, Medical Director of the Tulane Cancer Center, and Assistant
Dean for Oncology at Tulane University School of Medicine in New Orleans, Louisiana. Professor Sartor is a past member
of the Board of Scientific Counselors (Clinical Sciences and Epidemiology) at the National Cancer Institute and previously
served as Chairman of the Prostate Cancer Integration Panel for the US Department of Defense. Professor Sartor has
chaired five Data Monitoring Committees for Phase III trials that lead to FDA approval. He is medical oncology chair of
the Genitourinary committee of NRG Oncology. Professor Sartor received his Doctor of Medicine from Tulane University
with honours in 1982, before training in Internal Medicine at Tulane Medical School. After completing his fellowship at
the National Cancer Institute in Bethesda, Maryland in 1989, he served until 1993 as a Senior Investigator at the
National Cancer Institute with a focus on novel therapeutics for advanced prostate cancer patients.
Professor Richard Wahl. Professor Wahl is the Elizabeth Mallinckrodt Professor, Chairman of the Department of
Radiology and Director of the Mallinckrodt Institute of Radiology at Washington University School of Medicine in St
Louis. Professor Wahl is recognised as a world leader in the field of targeted radiopharmaceuticals for diagnosing and
treating cancer, with a key emphasis on PET imaging. Professor Wahl holds 18 radiology patents and has published
more than 450 peer-reviewed scientific papers and several books. He has been an inventor of a number of FDA
approved medical devices, such as radionuclide guided biopsy. He has served as a chairman of the American Board of
Nuclear Medicine (ABNM), president of the Institute for Clinical PET (ICP) program. He was elected as a member of the
US National Academy of Medicine in 2015. Most recently, Professor Wahl was elected 2021-22 president of the Society
of Nuclear Medicine and Molecular Imaging (SNMMI). He obtained his medical degree from Washington University in St
Louis, before completing residency training at the University of Michigan.
Professor Andrei Iagaru. Dr Iagaru is a Professor of Radiology – Nuclear Medicine and the Chief of the Division of Nuclear
Medicine and Molecular Imaging at Stanford University. His research focus includes PET/MRI and PET/CT imaging for
early cancer detection as well as peptide-based diagnostic imaging and therapy. Since joining the faculty at Stanford in
2007, Dr Iagaru has received several awards for his work in diagnostic imaging and nuclear medicine. Dr Iagaru
published more than 200 papers in peer-reviewed journals, as well as 7 book chapters and 1 book. He obtained his
medical degree from Carol Davila Medical School.
Dr Neal Shore. Dr Shore is the Chief Medical Officer of Urology/Surgical Oncology at GenesisCare US and the Medical
Director of Carolina Urologic Research Centre. He has conducted more than 400 clinical trials with a particular focus on
genitourinary oncology indications and is an internationally recognised expert and researcher in the field/ Dr Shore has
more than 250 peer reviewed publications and numerous book chapters. Dr Shore serves on the SITC Guidelines
Committee for Bladder Cancer as well as the boards of the Bladder Cancer Advocacy Network and the Duke Global
Health Institute. Dr Shore is on the editorial boards of Reviews in Urology, Chemotherapy Advisor, PLOS ONE, Urology
Practice, World Journal of Urology, and also serves as Editor at Everyday Urology-Oncology. He completed his general
surgery/urology residence at New York Hospital-Cornell Medical Center/Memorial Sloan Kettering Cancer Center and is
a Fellow of the American College of Surgeons.
Professor Jason Lewis. Professor Lewis is the Emily Tow Jackson Chair in Oncology and serves as Vice Chair for
Research in the Department of Radiology at Memorial Sloan Kettering Cancer Center (MSK), Chief of MSK’s
Radiochemistry & Imaging Sciences Service, and Director of MSK’s Radiochemistry and Molecular Imaging Probe Core
Facility. He is head of a laboratory in the Sloan Kettering Institute’s Molecular Pharmacology Program and a Professor at
the Gerstner Sloan Kettering Graduate School of Biomedical Sciences and at Weill Cornell Medical College. He is an
Adjunct Professor in the Department of Biomedical Imaging and Image Guided Therapy at The Medical University of
Vienna, Austria. He has served as the President of the World Molecular Imaging Society and was named a Fellow
(FWMIS) in 2015. He has received numerous awards in the field of radiology and nuclear medicine/ He has been named
a Fellow of the Society of Nuclear Medicine and Molecular Imaging (FSNMMI), a Fellow of the Royal Society of Chemistry
(FRSC) and a Fellow of the American Association for the Advancement of Science (FAAAS). In 2019 Professor Lewis
was awarded an NCI Outstanding Investigator Award (R35) to support his work in radiochemistry and molecular
imaging. Professor Lewis holds a PhD from The University of Kent (UK) and has published over 300 papers, books, book
chapters, and reviews in the field of cancer imaging.
Professor Andreas Kjaer. Professor Kjaer is a professor at the University of Copenhagen and a chief physician at the
Department of Clinical Physiology, Nuclear Medicine & PET at Rigshospitalet, the National University Hospital of
Denmark. Professor Kjaer is a former president of the Scandinavian Society of Clinical Physiology and Nuclear Medicine
(SSCPNM) and served on the Scientific Committee of the Danish Cancer Society and the European Association of Nuclear
Medicine (EANM) Oncology Committee. He is currently a member of the scientific advisory board of the European
Neuroendocrine Tumor Society (ENETS) and a member of the Industrial Research Committee of the Innovation Fund
Denmark. Professor Kjaer is founding Editor-in-Chief of Diagnostics (Basel), head of the Cluster for Molecular Imaging,
and director of the Postgraduate School for Medical and Molecular Imaging at the Faculty of Health Sciences, University
of Copenhagen. He is an elected member of the Danish Academy of Technical Sciences and a Knight of the Order of
Dannebrog, a Danish Royal Order of Chivalry. He received his medical degree from the University of Copenhagen and
has obtained numerous post-graduate qualifications, including an MBA from the Copenhagen Business School.

Professor Paul Donnelly. Professor Donnelly is the Clarity Group leader of the Donnelly Research Group at the
University of Melbourne, responsible for development of Clarity’s proprietary SART Technology. Professor Donnelly’s
expertise is in the application of synthetic inorganic/organic chemistry in biology and materials science, with a particular
focus on the application of coordination chemistry to metal-based drugs and the study of metal ions in biological
systems. Professor Donnelly has an impressive publication record and is the inventor of a number of novel and patented
radiopharmaceutical technologies. Paul is a graduate of the University of Western Australia and was a Post-doctoral
Junior Research Fellow at the University of Oxford.
Professor Louise Emmett. Prof Emmett is the Director of Theranostics and Nuclear Medicine at St Vincent’s Hospital
Sydney, a conjoint professor of medicine at the University of New South Wales and clinical research leader at the Garvan
Institute of Medical Research. Since joining the Nuclear Medicine and Positron Emission Tomography (PET) department
at St Vincent’s Hospital in 2012, Prof Emmett has been instrumental in developing the theranostics initiative at the St
Vincent’s Campus, introducing new radiopharmaceuticals for clinical and research evaluation of cancer as well as setting
up radiopharmacy production of a number of imaging and therapy tracers. Prof Emmett is the principal investigator of a
number of prospective randomised national trials in Australia in an effort to translate science from biotechnology
companies to clinic. She has published over 100 original papers in peer reviewed journals in the last 10 years, has
received a number of grants for clinical research and has presented at numerous national and international meetings.
Prof Emmett completed medical school at Auckland University prior to completing her specialty training in Nuclear
Medicine in Sydney and receiving her Fellow of the Royal Australasian College of Physicians (FRACP) qualification. She
undertook a specialty fellowship in Nuclear Cardiology at the University Health Network in Toronto, Canada and
completed a Doctorate of Medicine in Nuclear Cardiology through Auckland University.

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Date Theme Sector

13 September 2022 Initiation of Coverage Healthcare

Clarity Pharmaceuticals (CU6)

Bringing Clarity to radiopharmaceuticals

12-mth target price (AUD) $0.82

Wilsons Equity Research

 Business Description  Investment Thesis

Source: Company data, Wilsons estimate, Refinitiv.

Wilsons Equity Research Page 2

Wilsons Equity Research Page 3

Wilsons Equity Research Page 4

 1.1 Investment merits

Source: Clarity Pharmaceuticals.

Wilsons Equity Research Page 5

The use of copper radioisotopes bypasses the limitations of standard pairings.

Wilsons Equity Research Page 6

 1.2 Investment risks

Clinical risk. Clarity’s success depends on securing positive results from

Intellectual property risk. We summarise the company’s IP in Appendix 6

Wilsons Equity Research Page 7

 1.3 ESG considerations

Governance. We do not assess any critical governance risks in Clarity’s business.

Wilsons Equity Research Page 8

2. Clarity Pharmaceuticals: company overview and background

Source: Clarity Pharmaceuticals.

Wilsons Equity Research Page 9

Figure 4: Clarity’s core products and indications

Source: Clarity Pharmaceuticals.

Figure 5: Summary of Clarity’s clinical trial programs

Phase I/IIa (n=34) CL04

Wilsons Equity Research Page 10

Our initiating SOTP valuation comprises:

• Real options analysis of independent commercialisation of SARTATE NB diagnostic, SAR-bisPSMA diagnostic

Figure 6: SOTP valuation for Clarity Pharmaceuticals

Wilsons Equity Research Page 11

Whilst we view NB as the most straightforward indication to capture SARTATE Neuroblastoma

 3.2 Valuation sensitivities

Figure 8: Drivers of valuation sensitivity

Element Assumption (deviation from base case) ΔPT Revised PT

SAR-bisPSMA SAR-bisPSMA US diagnostic and/or therapy product pricing increased by ~30%

Clinical trial programs (SARTATE and/or SAR-bisPSMA and/or SAR-BBN) delayed

Wilsons Equity Research Page 12

Figure 9: Waterfall with de-risking events to our unrisked $4.07 PT

Wilsons Equity Research Page 13

 3.3 M&A Transactions within the radiopharmaceutical space

Figure 10: Value creation by Endocyte for PSMA-617 assets

Wilsons Equity Research Page 14

Figure 11: Program timeline overview FY23e-FY30e

SAR-BBN prostate Dx Direct

SAR-BBN prostate Tx Partner

Phase I-IIb trials

Wilsons Equity Research Page 15

Wilsons Equity Research Page 16

Figure 15: SAR-bisPSMA market and pricing assumptions (US market)

Wilsons Equity Research Page 17

Figure 16: Extended forecast snapshot (FY23e-FY32e)

*Cash includes term deposits.