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. New Risk • Feb 03
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 40% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 59% per year over the past 5 years. Shareholders have been substantially diluted in the past year (40% increase in shares outstanding). Minor Risks Revenue is less than US$5m (AU$1.5m revenue, or US$1.1m). Market cap is less than US$100m (AU$62.0m market cap, or US$43.1m). 
