Clarity Pharmaceuticals : Half Yearly Report

onlyINTERIM REPORT

useand Half-Year Financial Statements

SYDNEY, AUSTRALIA

28 FEBRUARY 2022 personalFor

Key Financials
only
• Cash balance at 25 February	• Loss for the period of $13.7 million
	2022 - 97.5 million	up from $4.9 million in the pcp.
		Increased loss driven by higher
		operation spend together with a
• Net operating cash outflows	$6.8 million Share Based Payments
use	of $8.7 million for the period,	expense relating to options granted to
	up from $4 million in the prior	China Grand (please refer Corporate
	corresponding period (pcp),	Update below for further information)
	reflecting increased investment
	in research & development (R&D)
personal	and clinical trial costs.
Operational Highlights
• Actively recruiting patients across	• A third prostate cancer trial with 64Cu-
	four clinical trials	SAR-bisPSMA COBRA trial received a
		Study May Proceed confirmation from
		the US Food and Drug Administration
• Two clinical trials for the optimised	(FDA) in February 2022 with plans to
	PSMA agent, SAR-bisPSMA, in	commence recruitment of patients
	prostate cancer, which commenced	with biochemical recurrence of
	in July 2021, are progressing well:	prostate cancer in the second quarter
	• Completed the dosimetry phase	of 2022
	in the US-based SECuRE trial
For	for the treatment of prostate	• Early completion of the C-BOBCAT
cancer in November 2021
diagnostic trial with 64Cu SAR-
• Achieved 50% recruitment

milestone in the Australia-	Bombesin in October 2021 with plans
to commence US-based clinical trials
based PROPELLER trial for the
of this product during 2022
imaging of prostate cancer in
December 2021
	• Completed cohort 1 in the
	neuroblastoma therapy trial with
	67Cu SARTATETM in the US, advancing
	to the next dose level with the first
	patient in cohort 2 successfully
	treated in February 2022

• Successfully completed the largest biotechnology Initial Public Offering (IPO) on the Australian Securities Exchange (ASX), raising $92 million
• Received the FY21 R&D tax incentive cash refund of $3.3 million in February 2022

• Execution of US radiopharmaceutical manufacturing agreements with Evergreen Theragnostics, Inc in September 2021 and with Cardinal Health in December 2021
• Reinforced the IP position around the optimised PSMA targeting agent, SAR-bisPSMA, with the patent application covering formulations of SAR-bisPSMA entering the national phase in a number of jurisdictions, including the USA, Europe and China
• Filed six provisional patents, while moving other patent applications ahead through the various stages of the patenting process

2

DISCO

progressed the theranostic neuroblastoma trial to cohort 2 at the increased dose level.

Clarity has significantly expanded its manufacturing and logistical footprint in order to allow for seamless clinical growth as well as future commercialisation of its products, ensuring the Group fully leverages clinical, manufacturing and logistical benefits of the TCT platform.

The Group also progressed its preclinical and discovery programs and continued to bolster its IP portfolio to support the comprehensive platform of TCT. Clarity continued to attract exceptional talent, growing its team and Board of Directors to achieve a unique mix of expertise that enables the development of next- generation radiopharmaceuticals.

Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or the "Group"), an Australian-based clinical stage radiopharmaceutical company developing next-generation products to

onlyaddress the growing need for the use of radiopharmaceuticals in oncology, is pleased to release its interim report and financial results for the half-year ended 31 December 2021.

useExecutive Chairman Alan Taylor said: "During the

r porting period Clarity reached focal milestones across all key areas of our business, including corporate, clinical, operations and regulatory functions. The

nforeseen challenges imposed by the global pandemic did not stop Clarity from exceeding the goals we set for ourselves as we completed the largest biotechnology

Initial Public Offering (IPO) on the Australian Securities personalExchange (ASX), raising $92 million, while also

significantly progressing clinical development of our pipeline of Targeted Copper Theranostics (TCT)."

Since 1 July 2021, Clarity launched three new clinical trials in prostate cancer (two diagnostic and one theranostic trial), closed a diagnostic trial of SAR- Bombesin following the exciting preliminary results, and

Dr Taylor said: "We are very excited to continue the pace we picked up in 2021 to further grow our company, delivering exciting milestones in 2022 and building towards commercialisation of our TCT products, in pursuit of our ultimate goal of developing better treatments for children and adults with cancer."

Clarity's pipeline includes the following indications of cancer, products and clinical trials to date:

Indication		Prostate Cancer	Breast Cancer	Neuroblastoma	Neuroendocrine
	Tumours
Product	SAR-bisPSMA	SAR-Bombesin	SAR-Bombesin	SARTATE™	SARTATE™
For
Application	Theranostic	Diagnostic	Diagnostic	Diagnostic	Theranostic	Diagnostic

Trial Name

C-BOBCAT

SECuRE PROPELLER COBRATGA Special- resultsCL04 Access Scheme

in 2022

3

CLINICAL

DEVELOPMENT

	Clarity continues to generate strong results in the clinical development of the products
	in the TCT platform. With the earlier completion of the C-BOBCAT trial with 64Cu SAR-
only
	Bombesin in October, the G now actively recruiting in four clinical trials. Additionally,
	the US-based64Cu SAR-bisPSMA COBRA trial is currently in the start-up phase with
	recruitment anticipated to commence in the second quarter of 2022 and a US-based
	64Cu SAR-Bombesin trial is also scheduled to commence during 2022.
use
	Indication	Product		Discovery Preclinical Phase 1 Phase 2 Phase 3	Next Milestone
		SAR-bisPSMA	Theranostic		First therapy treatment
		mCRPC
			Diagnostic in
		SAR-bisPSMA	pre-radical		Recruitment complete
			prostatectomy
	Prostate Cancer		Diagnostic in
		SAR-bisPSMA		1st patient treated in COBRA
		BCR PCa
		SAR-BBN	Diagnostic in		Open IND for 64Cu SAR-BBN
		BCR PCa
		SAR-BBN	Theranostic		Open IND for 67Cu-SAR-BBN
		SARTATETM	Theranostic		Cohort 2 completed
	Neuroblastoma
personal	SARTATETM	Diagnostic		Open IND for NB Dx
	NETs	SARTATETM	Diagnostic		50% recruitment in DISCO
	Pan cancer
	(GRPr positive	SAR-BBN	Diagnostic		1st patient in GRPr +ve tumour
	tumours)
	SAR Discovery	Undisclosed	Undisclosed
For
	Platform	Undisclosed	Undisclosed

Current Progress 12 Months Progress

All US studies are conducted under IND

As of 28 February 2022

Note clinical development pipeline is indicative only and is subject to review

4

SAR-bisPSMA - Prostate Cancer

onlySAR-bisPSMA is a next generation, highly targeted theranostic radiopharmaceutical, being developed for diagnosing, staging and subsequently treating cancers that express

useProstate Specific Membrane Antigen (PSMA).

SAR-bisPSMA derives its name from the word "bis", which reflects the novel approach of connecting two PSMA binding motifs to Clarity's SAR chelator technology to increase tumour uptake and retention in

personalcancerous tissues. Preliminary clinical data from the PROPELLER trial is aligning with preclinical data where product uptake appears to be higher for 64Cu SAR- bisPSMA than that of the first-generation PSMA agents that use a single PSMA binding motif. The PET imaging data acquired in the SECuRE trial to date also looks very promising with high tumour targeting and retention.

The term "bis" is used to denote the presence of

two identical but separate binding motifs in one molecule

For

5