Catalyst Calendar

Q1 2026 revenue from SOFDRA US launch, key inflection metric

Quarterly sales update, targeting continued US market penetration

Quarterly update on global Trophon2 installed base expansion

Quarterly sales update for US surgical products

Dimerix conducting a blinded review of ACTION3 Phase 3 statistical assumptions (primary endpoint: % reduction in proteinuria vs placebo). Review uses methods prespecified in the Statistical Analysis Plan submitted to the FDA. The blinded review is independent and maintains study integrity. Results expected April 2026. Confirms trial is powered to detect treatment effect. Previously passed 7 IDMC reviews with no safety concerns and a March 2024 futility analysis.

First patient dosing in the PROTECT-MI Phase IIa trial expected in April 2026. [Source: Nyrada PROTECT-MI Phase IIa Trial To Commence, 2026-03-18]

Primary completion expected for NCT06055439. Indication: {"Neuroendocrine Tumors","Colorectal Cancer","Gastric Cancer"}

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

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

Primary completion expected for NCT05355298. Indication: {"Pancreatic Cancer",PDAC,"Pancreatic Ductal Adenocarcinoma"}

Quarterly royalty from Acadia Pharmaceuticals on US DAYBUE sales

Updated safety and efficacy data from solid tumour trial

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

Primary completion expected for NCT04090424. Indication: {Burns}

Azer-cel clinical data to be presented at 2026 ASCO Annual Meeting

New preclinical data for HMBD-002 (anti-VISTA antibody) accepted for presentation at ASCO 2026

Initial dose-response data in acute myeloid leukaemia

Primary completion expected for NCT05866952. Indication: {"Post-Acute COVID-19","Post COVID-19 Condition","Post Viral Fatigue",Dyspnea}

CF33/VAXINIA + pembrolizumab combination data

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"}

SAD Phase I results for LAG-3 agonist IMP761 to be presented at EULAR Congress, London; dose-dependent T cell suppression demonstrated

SAD/MAD data for first-in-class LAG-3 agonist in autoimmune disease

Phase 2 results for acne vulgaris candidate

Cash runway under 6 months at current burn

Zirconium-89 PET imaging agent for renal cell carcinoma

COAST pivotal trial topline results

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

Phase 2 data in mild-moderate Alzheimer disease via cortisol modulation

Progress on new endoscope reprocessing platform regulatory pathway

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

Collagen dermal matrix study fully enrolled Dec 2025; data expected H1 2026 per management guidance

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

Phase 2 aGvHD trial fully enrolled Dec 2025; 100-day evaluation period complete ~March 2026; results expected Q2 2026

World-first Phase 3 iPSC cell therapy trial; final patient visits complete Dec 2025; data lock underway; top-line results expected Q2 2026

Collagen dermal matrix clinical study top-line results

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

Primary endpoint: overall response rate at Day 28 in high-risk acute GvHD

SCUlpTOR trial — world first Phase 3 iPSC-derived cell therapy; final visits complete Dec 2025

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