On July 28, 2025 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, reported the successful completion of a $203 million placement to institutional investors ("Placement") (Press release, Clarity Pharmaceuticals, JUL 28, 2025, View Source [SID1234654571]).
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The offer price per new fully paid ordinary share issued under the Placement ("New Share") was $4.20 ("Offer Price"), representing a 2.2% premium to Clarity’s last closing price and an 18.0% premium to the 15-day VWAP. Following the completion of the Placement, the Company will have a pro-forma cash balance of approximately $288 million1, which will help fund Clarity in connection with the below-mentioned expected catalysts and milestones, including the specified clinical trial programs.
Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "The last eight months have been an incredibly tumultuous period for global markets generally, driven by the US political environment. When these times occur, pre-revenue biotechnology companies can be affected significantly more than other businesses due to their need to raise capital in order to get products to market. In addition to the global financial turmoil, there has been some unfortunate news from local biotechnology companies, putting significant pressure on the Australian biotechnology market. Being a successful pre-revenue biotechnology company listed on the ASX also presents additional considerations. For Clarity in particular, the inclusion of the Company in a number of indices over this period, such as the ASX200 and ASX300, has significantly raised the profile of the Company to certain investor groups, including index funds. These factors, amongst other variables, have contributed to the volatility in Clarity’s share price and an increasing number of short positions in our Company, reaching approximately 10% of our current total number of shares on issue.
"However, during this period of volatility our team has not lost sight of our purpose: to better the lives of people living with cancer. This drive has resulted in the achievement of many substantial milestones across our entire business, including outstanding clinical trial data, validation of new products in pre-clinical development, roll-out of enhanced supply and manufacturing in preparation for potential commercialisation and a number of important regulatory objectives.
"The coalescing of strong company fundamentals with ASX investor dynamics provided Clarity with an opportunity to capitalise with a fast, well-executed and sizeable placement to a small number of institutional investors who are close to the Company. The Placement has received phenomenal support, evidenced by the raising of over $200 million at not only a premium to the last closing share price, but a substantial premium to the share price observed for almost the entirety of CY2025. This places Clarity in a strong position, with an enviable Balance Sheet, where we can work to complete a number of high value-driving clinical trials, including our pivotal Phase 3 trials, as we progress our products towards potential commercialisation. The completion of the institutional Placement, coupled with significant short- and medium-term deliverables, such as the read-outs of the Co-PSMA trial and the Phase 3 trials, respectively, as well as longer-term activities, such as the further development of our therapy programs, are expected to underpin short-, medium- and longer-term shareholder value growth as we work towards our ultimate goal of better treating people with cancer."
Bell Potter Securities Limited acted as Sole Lead Manager. Lander & Rogers acted as Clarity’s Australian legal adviser.
UPCOMING EXPECTED CATALYSTS AND MILESTONES
Clinical Development
64Cu-SAR-bisPSMA diagnostic program in prostate cancer
Co-PSMA investigator-initiated trial (head-to-head, biochemical recurrence [BCR]): Readout Q3/4 CY2025
AMPLIFY trial (Phase 3, BCR): Enrolment complete Q4 CY2025
CLARIFY trial (Phase 3, pre-prostatectomy): Enrolment complete H1 CY2026
New Drug Application (NDA) planning and submission activities in anticipation of positive trial results
64/67Cu‑SAR‑bisPSMA theranostic program in prostate cancer
SECuRE (Phase 2, Cohort Expansion): Anticipated enrolment complete by Q1 CY2026
⁶⁴Cu‑SAR‑Bombesin diagnostic program in prostate cancer
Ongoing data review following positive Phase II SABRE topline trial data (June 2025) for prostate-specific membrane antigen (PSMA)-negative prostate cancer
Continued planning for the next trial and possible alternative indications with 64Cu-SAR-Bombesin
64Cu-SARTATE diagnostic program in neuroendocrine tumours (NETs)
Phase 3 trial planning following positive DISCO topline trial data (June 2025): Anticipated End-of-Phase (EOP) meeting with the US Food and Drug Administration (FDA) H2 CY2025
Pipeline Advancements
Pre-clinical development of the theranostic 64/67Cu-SAR-trastuzumab product in breast cancer and the diagnostic 64Cu-SAR-bisFAP product: Complete H1 CY2026
First-in-human trials for both products: Initiate clinical programs H2 CY2026
Continued Strategic Manufacturing Expansion of 64Cu-SAR-bisPSMA
Initial NDA and US commercial supply readiness
Additional agreements established for copper-64 and drug product manufacturing capacity in preparation for proposed commercial launch of 64Cu-SAR-bisPSMA globally: CY2025/6
Global Commercial Team Buildout for 64Cu-SAR-bisPSMA Launch
Hiring of key roles for proposed product launch of 64Cu-SAR-bisPSMA, including Sales, Marketing and Market Access.