Announcement • Jul 17
Neurizon Therapeutics Limited Completes Enrollment In Regimen I Of The Phase 2/3 HEALEY ALS Platform Trial Evaluating NUZ-001 For The Treatment Of Amyotrophic Lateral Sclerosis Neurizon Therapeutics Limited advised that enrolment has been completed in Regimen I of the Phase 2/3 HEALEY ALS Platform Trial evaluating the Company's lead investigational therapy NUZ-001 for the treatment of amyotrophic lateral sclerosis (ALS). Neurizon advised that the final participant has completed their baseline visit and commenced treatment, completing enrolment into Regimen I. The Company now expects to report topline efficacy and safety results in late Second Quarter Calendar Year 2027, earlier than previously anticipated. Completion of enrolment, together with the earlier anticipated timing of the topline results readout, further demonstrates the continued advancement of the late-stage clinical development program for NUZ-001 for the treatment of ALS. Regimen I completed enrolment in less than five months from first participant dosing, becoming the fastest regimen to activate sites and complete enrolment in the HEALEY ALS Platform Trial, even after the planned sample size expansion from 160 to 240 participants in response to strong recruitment momentum. This achievement reflects the strength of recruitment across the HEALEY ALS Platform Trial network, one of the world's leading ALS clinical trial initiatives, the operational efficiencies introduced under the trial's next generation master protocol, and the commitment of investigators, research coordinators and clinical site teams across the United States. Participants will now continue through the 36-week Randomised Controlled Trial phase before entering the 36-week Active Treatment Extension phase, with the Company's focus centred on continued execution ahead of the anticipated topline readout in late Second Quarter Calendar Year 2027. The HEALEY ALS Platform Trial (ClinicalTrials.gov identifier: NCT04297683) is a multicentre, double-blind, placebo controlled adaptive Phase 2/3 clinical trial conducted by the Sean M. Healey & AMG Center for ALS at Mass General Brigham in the United States, created in partnership with the Network of Excellence for ALS (NEALS). Entry into the HEALEY ALS Platform Trial is competitive, with drug candidates reviewed and selected by expert committees based on scientific merit and evidence of potential benefit in ALS. The goal of the HEALEY ALS Platform Trial is to accelerate the development of potential new ALS therapies. NUZ-001 is an investigational product and is not approved for commercial use in any jurisdiction. Announcement • Mar 19
Neurizon Therapeutics Limited has completed a Follow-on Equity Offering in the amount of AUD 7.106469 million. Neurizon Therapeutics Limited has completed a Follow-on Equity Offering in the amount of AUD 7.106469 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 9,500,000
Price\Range: AUD 0.08
Discount Per Security: AUD 0.0048
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 79,330,864
Price\Range: AUD 0.08
Discount Per Security: AUD 0.0048
Transaction Features: Subsequent Direct Listing Announcement • Feb 27
Neurizon Therapeutics Limited Initiates Dosing of NUZ-001 in HEALEY ALS Platform Trial Neurizon®? Therapeutics Limited announced that the first participant has been dosed in Regimen I of the HEALEY ALS Platform Trial evaluating Neurizon's lead candidate, NUZ-001, for the treatment of amyotrophic lateral sclerosis (ALS). The HEALEY ALS Platform Trial (ClinicalTrials.gov identifier: NCT04297683) is a multicentre, double-blind, placebo-controlled adaptive Phase 2/3 clinical trial conducted by the Sean M. Healey & AMG Center for ALS at Mass General Hospital Brigham in the United States (US), created in partnership with the Network of Excellence for ALS (NEALS). Entry into the HEALEY ALS Platform trial is competitive, with drug candidates reviewed and selected by expert committees based on scientific merit and evidence of potential benefit in ALS. The goal of the HEALEy ALS Platform Trial is to accelerate the development of potential new ALS therapies. The trial evaluate multiple investigational drugs (Regimens) concurrently under a single framework or master protocol, leveraging shared infrastructure across over 70 participating clinical sites. By streamlining start-up and enrollment processes, it accelerates study execution and delivers results more efficiently. Regimen I (NUZ-001) includes a randomised, placebo-controlled treatment (RCT) phase followed by an active treatment extension (ATE) phase, both with a 36-week treatment period. Approximately 160 participants with ALS will be randomised to receive either daily NUZ-001 at the recommended Phase 2 dose of 10 mg/kg or placebo at a 3:1 ratio. The primary objective is to evaluate the efficacy of NUZ-001 compared with placebo on ALS disease progression, with secondary objectives including additional measures of disease progression and safety. Participation in the HEALEY ALS platform Trial provides Neurizon with access to an established clinical development framework supported by the world's most highly regarded ALS investigators and leading clinical centres across the US. This infrastructure improves trial efficiency, supports consistent data generation and facilitates ongoing engagement with regulatory authorities, including the U.S. Food and Drug Administration (FDA), as the trial progresses. 
