Catalyst Calendar

Quarterly update on global Trophon2 installed base expansion

Quarterly sales update for US surgical products

Primary completion expected for NCT07463716. Indication: {"Healthy Volunteers"}

Primary completion expected for NCT07336654. Indication: {"Circadian Rhythm"}

Primary completion expected for NCT05080998. Indication: {"Urothelial Bladder Cancer"}

Initial dose-response data in acute myeloid leukaemia

Primary completion expected for NCT07052214. Indication: {PCA,"Prostate Cancer","Prostatic Neoplasm","PSMA PET","Diagnostic Imaging","Elevated PSA","Positron Emission Tomography","Prostate Biopsy","Carcinoma of the Prostate"}

Primary completion expected for NCT05450744. Indication: {"Neoplastic Disease",Glioblastoma,"Glioblastoma Multiforme"}

Primary completion expected for NCT07420140. Indication: {"OSA - Obstructive Sleep Apnea"}

Phase 2 results for acne vulgaris candidate

Zirconium-89 PET imaging agent for renal cell carcinoma

COAST pivotal trial topline results

6 of 7 Medicare Administrative Contractors have published RECELL payment rates; final MAC publication outstanding

Collagen dermal matrix clinical study top-line results

Completion of enrolment in the SOLVE-CRT pivotal trial

Primary completion expected for NCT06750419. Indication: {"Clear Cell Renal Cell Carcinoma"}

Company expects to receive approximately AUD $7.5M in R&D Tax Incentive credits for FY2026. [Source: AUD $3.7M Income Tax Refund Received, 2026-06-30]

Settlement terms allow competing generics at end of FY2026. Revenue headwind for dermatology segment

Phase 1 FIH completed 2025, all 3 cohorts cleared by Safety Review Committee

Comprehensive data from 10-subject Phase 2b therapeutic arm. Top-line showed reduced viral load and symptoms

Initial shipment of Dr Watson® medicinal cannabis flower SKUs to Costa Rica under the expanded Remidose LATAM supply agreement expected to exceed AUD $500,000. [Source: Expands LATAM Footprint First Supply Agreement Costa Rica, 2026-05-10]

BCAL's multi-cancer early detection test is expected to launch in June 2026, representing a key commercial milestone following the platform infrastructure launch. [Source: BCAL Launches Early Detection Cancer Platform, 2026-05-19]

Court decision on Cosette's appeal of the October 2025 judgment, with appeal hearing completed on 2-3 June 2026 and decision reserved. [Source: Mayne Pharma receives $14.4m for legal costs from Cosette, 2026-06-05]

The recommended INN status for xaranetide (ARG-007) is expected to be published shortly following WHO confirmation. [Source: WHO Confirms Xaranetide as INN for ARG-007, 2026-06-09]

Update on Medicare/insurance reimbursement pathway for XV Technology

Phase III CLARIFY imaging trial recruitment completion expected 2026

FDA-agreed Phase III of Cu-64 SARTATE imaging in neuroendocrine tumours, recruitment starting 2026

Pivotal trial of apolipoprotein A-I in acute coronary syndrome, data expected 2026

Southern hemisphere influenza vaccine revenue for 2026 season

Working with FDA on pathway for US approval in SR-aGvHD

Continued patient dosing and follow-up data in retinitis pigmentosa type 11

Progress on new endoscope reprocessing platform regulatory pathway

Continued follow-up data from ADAPT tissue-engineered aortic valve trial

7th MAC to publish RECELL payment rates — 6 of 7 already confirmed

First European marketing authorization filing for NEURACTHEL ACTH therapy, representing Clinuvel's expansion into neurological/endocrinological disorders.

Connected oral appliance therapy study supporting efficacy monitoring claim for FDA 510(k)

Covers both Breast C and D density women (~50% of screened population). Following 800-patient study

FDA approved Aug 2024, launched May 2025 via TruPharma. US market >US$37.4M annually

Primary completion expected for NCT06939920. Indication: {"Respiratory Failure Requiring Non Invasive Ventilation"}