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. Board Change • May 20
Less than half of directors are independent There are 5 new directors who have joined the board in the last 3 years. Of these new board members, 1 was an independent director. The company's board is composed of: 5 new directors. No experienced directors. 3 highly experienced directors. 1 independent director (3 non-independent directors). Veterinary Clinical Advisory Board Chair Angela Frimberger is the most experienced director on the board, commencing their role in 2017. Independent Non-Executive Director Ross Murdoch was the last independent director to join the board, commencing their role in 2026. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of board continuity. Lack of experienced directors. 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. Announcement • Dec 24
Neurizon Therapeutics Limited has filed a Follow-on Equity Offering in the amount of AUD 17.145251 million. Neurizon Therapeutics Limited has filed a Follow-on Equity Offering in the amount of AUD 17.145251 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 214,315,640
Price\Range: AUD 0.08
Transaction Features: Rights Offering Announcement • Dec 23
Neurizon Therapeutics Limited has filed a Follow-on Equity Offering in the amount of AUD 7.126469 million. Neurizon Therapeutics Limited has filed a Follow-on Equity Offering in the amount of AUD 7.126469 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 89,080,864
Price\Range: AUD 0.08
Discount Per Security: AUD 0.0048
Transaction Features: Subsequent Direct Listing Announcement • Oct 06
Neurizon Therapeutics Limited Announces U.S. Food and Drug Administration Lifts Clinical Hold on Nuz-001 Neurizon Therapeutics Limited announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on its lead investigational drug, NUZ-001. This decision marks a pivotal regulatory milestone for Neurizon and the ALS community, clearing the way for Phase 2/3 development of NUZ-001 as part of the HEALEY ALS Platform Trial, expected to commence Fourth Quarter CY2025. Opening an IND for a platform molecule establishes a regulatory foundation that not only accelerates the development of the first candidate but also streamlines future programs. By creating a validated framework for safety, manufacturing, and clinical design, it reduces regulatory risk, shortens timelines, and enables efficient expansion into new indications. In this case, the IND is further strengthened by the robust and comprehensive package of preclinical safety data and the detailed manufacturing and quality information secured through licensing agreement with Elanco. These resources enhance confidence in the platform's readiness for clinical development and reinforce its potential as a therapeutic platform with broad applicability, offering both strategic flexibility and long-term commercial value. Next steps: With IND now active, Neurizon anticipates Mass General Hospital (MGH) filing a protocol amendment to their IND for the HEALEY ALS Platform trial to incorporate specific protocol regimen early in the coming weeks. Neurizon expects to initiate patient enrollment in the HEALEY ALS Platform trials in fourth quarter of 2022. Together, these milestones advance Neurizon's mission to accelerate patient access to innovative therapies, create long-term value for shareholders, and establish NUZ-001 as a potential effective treatment for ALS. This announcement has been authorized for release by the Board of Neurizon Therapeutics Limited. Announcement • Sep 19
Neurizon Therapeutics Limited has completed a Follow-on Equity Offering in the amount of AUD 5.2 million. Neurizon Therapeutics Limited has completed a Follow-on Equity Offering in the amount of AUD 5.2 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 42,249,999
Price\Range: AUD 0.12
Discount Per Security: AUD 0.0072
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 1,083,335
Price\Range: AUD 0.12
Discount Per Security: AUD 0.0072
Transaction Features: Subsequent Direct Listing Announcement • Aug 05
Neurizon Therapeutics Limited, Annual General Meeting, Sep 30, 2025 Neurizon Therapeutics Limited, Annual General Meeting, Sep 30, 2025. Announcement • Jun 18
Neurizon® Therapeutics Limited Announces New Preclinical Data Demonstrating Significant Neuroprotective Effects of Nuz-001 Sulfone Neurizon Therapeutics Limited announced new preclinical data demonstrating significant neuroprotective effects of NUZ-001 and its active metabolite, NUZ-001 Sulfone, in a zebrafish model of Huntington's disease (HD). HD is a rare, inherited neurodegenerative disorder that causes progressivedegeneration of motor function, cognition, and mental health. In this disease model of HD, the targeted knockdown of the Htt (huntingtin) protein mRNA knockdown approach, triggers characteristic HD-related deficits, including increased cell death (acridine orange staining), morphological malformations, impaired haemoglobin production (Benzidine staining), and reduced expression of brain-derived neurotrophic factor (BDNF), a critical biomarker of neuronal function and survival. Treatment with NUZ-001 or NUZ-001 S sulfone following Htt knockdown prevented developmental and morphological abnormalities, attenuated neuronal cell death, restored the delayed production of haemoglobin, and rescued BDNF expression, providing evidence of their potential to counteract early neurodegenerative damage. HD is a devastating, rare genetic disorder that causes the progressive breakdown of nerve cells in the brain, leading to a range of symptoms including uncontrolled movements, cognitive decline, and emotional disorders. HD affects between 2.7 and 4.8 per 100,000 people globally. There is no cure and no disease-modifying treatments, only treatments that manage symptoms. These exciting results demonstrate NUZ-001 has consistent neuroprotective effects beyond amyotrophic lateral sclerosis (ALS), strengthening company conviction in NUZ-001's potential as a disease-modifying platform therapy across a range of neurodegenerative conditions. Wild-type zebrafish embryos were raised in standard conditions. Morpholino antisense oligonucleotides (MOs) targeting Htt were injected into one-cell stage embryos to decrease Htt expression. NUZ-001 orNUZ-001 Sulf one at 1 and 10 mM concentrations were added to the embryonic media 6 hours post-fertilisation to evaluate the protective effects of NU Z-001 and NUZ-001 S Gulfone on Htt knockdown-induced deficits. Changes in morphology (eye size and hindbrain swelling), neuronal cell death (apoptosis), and the levels of BDNF expression were analysed 2 days post-fertilisation. Knockdown of Htt (Htt MO) resulted in zebrafish embryos with smaller eyes and swollen hindbrain ventricles. Treatment with 1 mM and 10 mM NUZ-001, and 10 mM NUZ -001 Sulfone significantly significantly increased in the Htt knockdown zebrafish embryos compared to the control group. Treatment with 1 mM and10 mM NUZ-001 S sulphone significantly increased the Htt (Htt MO). Treatment with 1 mM and 10 million NUZ-001, & 10 mM NUZ-002 Sulfone significantly increased the number of neurodegenerative diseases. Announcement • Apr 01
Neurizon Therapeutics Limited Announces Results from an Independent Study Conducted in Collaboration with Tessara Therapeutics Neurizon Therapeutics Limited announced that results from an independent study undertaken in collaboration with Tessara Therapeutics will be presented by the group's Principal Scientist and Alzheimer's Disease expert, Dr Mark Greenough at the AD/PD 2025 Advances in Sciences & Therapy conference on April 2nd to 3rd. The results are part of a study in ongoing collaboration with Tessara, a leading biotechnology company pioneering a new approach in 3D cell-based models of the brain, having developed its RealBrain 3D human micro-tissues technology that replicates the biological complexity of the human brain in a scalable and reproducible manner. Tessara has validated and recently launched two brain models: the ArtiBrainTM model (healthy human brain) and the ADBrainTM model (Alzheimer's disease). Tessara has leveraged these models to explore the effect of Neurizon's lead candidate, NUZ-001. In addition, the compounds appear to offer neuroprotective effects against ferroptosis and encourage neural branching, potentially boosting plasticity by enabling neurons to form additional connections. While further research is needed to clarify the mechanisms responsible for these benefits, current data suggest that longer-term treatment may enhance network density and overall plasticity. In humans, this could translate into tangible benefits in cognition, learning, memory, or resilience to neurodegenerative processes involved in diseases such as Alzheimer's disease, Parkinson's disease and Amyotrophic Lateral Sclerosis (ALS). As part of ongoing initiatives with Tessara, the therapeutic efficacy of NUZ-001 is now being assessed through other screening modalities, including Tessara's ADBrainTM platform, for sporadic Alzheimer's disease. Results from further testing are anticipated this quarter and will be used to assess the potential for NUZ to expand its lead asset into a broader range of indications. Through its proprietary RealBrain®? platform, Tessara has developed the first scalable, reproducible 3D human brain micro-tissue models that closely replicate both healthy and diseased neural physiology. By enabling cost -effective, high-throughput screening and delivering predictive, human-relevant data, Tessara's approach accelerates discovery timelines, enhances the likelihood of successful clinical trials, and supports the industry-wide shift to non-animal research. This platform offers an opportunity to submit questions, share comments, and view video summaries of key announcements. Announcement • Dec 18
Neurizon Files IND Application to Support HEALEY ALS Platform Trial Neurizon Therapeutics Limited announced the filing of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its lead candidate, NUZ-001. This milestone is a pivotal step in enabling the commencement of a Phase 2/3 clinical trial within the HEALEY ALS Platform Trial framework. The FDA has a period of 30 days to review the IND application. Pending FDA clearance of the IND application, Neurizon anticipates Massachusetts General Hospital (MGH) filing a protocol amendment to their IND for the HEALEY ALS Platform Trial to incorporate our regimen specific appendix in First Quarter CY2025. Neurizon expects to initiate patient enrollment in the HEALEY ALS Platform Trial in H1 CY2025. Announcement • Nov 19
Neurizon's NUZ-001 Reduces Aggregation of Key ALS Disease Target TDP-43 in Preclinical Study Neurizon Therapeutics Limited announced positive results from a preclinical study of its lead candidate, NUZ-001. These innovative studies reveal NUZ-001's unique mechanism of action in preventing the aggregation of TAR DNA-binding protein 43 (TDP-43), a key pathological feature of ALS, and the ability of NUZ-001 to significantly improve the electrophysiological dysfunction of TDP-43 M337V mutated motor neurons, showcasing the potential for NUZ-001 to be a transformative treatment for ALS. Importantly, these findings reinforce the promising efficacy results seen in Neurizon's Phase 1 MEND study and bolster confidence in NUZ-001 therapeutic capabilities for patients with ALS. Two separate preclinical studies were conducted in collaboration with Ncardia, a leading human induced pluripotent stem cell (iPSC) technology company. The first study evaluated the ability of NUZ -001 and its major active metabolite (NUZ-001 Sulfone) to reduce TDP-43 aggregation in M337V Motor Neurons co-cultured with orocytes in response to a stressor. TAR DNA-binding protein43 (TDP-43) is a known driver of ALS pathology. The results show NUZ-001 and NUZ-001 S sulfone significantly and dose-dependently reduced TDP-43 aggregation inM337V Motor Neurons treated simultaneously with aggregation stressor MG-132 by 50% and 55%, respectively. The second study evaluated the ability of NUZ-001 and NUZ-001 Sulfone to restore the normal electrophysiological function of TDP-43 mutated M337V Motor Neurons. The TDP-43 M337V mutation is associated with the development of ALS and has been shown to impair neuronal electrical activity at multiple levels. NUZ-001 and NUZ-001 Sulfone rescued the electrical activity of TDP-43 M337V Motor Neurons, by increasing bursting and network burst activity, and reducing inter-burst intervals to wild type Motor Neuron activity levels. The ability of NUZ-001 to target TDP-43 aggregation and repair motor neuron function positions it as a promising lead candidate for the treatment of ALS, where effective treatments remain scarce. With its novel mechanism, NUZ-001 has the potential to address ALS pathology at its core, offering hope to patients and caregivers affected by this debilitating disease. The ALS treatment market, projected to grow significantly in the coming years, presents a critical opportunity for NUZ-001 to fill a longstanding therapeutic gap. TDP-43 protein aggregation is common in several neurodegenerative diseases, including ALS, frontotemporal dementia (FTD), Alzheimer's disease (AD), and limbic predominant age-related TDP-43 encephalopathy (LATE). In ALS, cytoplasmic accumulation of TDP-43 disrupts cellular processes, leading to motor neuron dysfunction and degeneration. By targeting TDP-43 pathology, NUZ-001 offers a new approach to mitigating ALS progression and highlights the potential for expanded applications in other neurodegenerative diseases. Announcement • Aug 05
PharmAust Limited, Annual General Meeting, Sep 30, 2024 PharmAust Limited, Annual General Meeting, Sep 30, 2024. Announcement • Jun 21
PharmAust Limited has filed a Follow-on Equity Offering. PharmAust Limited has filed a Follow-on Equity Offering.
Security Name: Ordinary Shares
Security Type: Common Stock
Transaction Features: Subsequent Direct Listing Announcement • Dec 15
PharmAust Limited has completed a Follow-on Equity Offering in the amount of AUD 3.459 million. PharmAust Limited has completed a Follow-on Equity Offering in the amount of AUD 3.459 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 34,590,000
Price\Range: AUD 0.1
Discount Per Security: AUD 0.006
Transaction Features: Subsequent Direct Listing Announcement • Nov 23
PharmAust Limited has announced a Derivatives Offering in the amount of AUD 39.612456 million. PharmAust Limited has announced a Derivatives Offering in the amount of AUD 39.612456 million.
Security Name: Options
Security Type: Equity Option
Securities Offered: 79,224,912
Price\Range: AUD 0.5 Announcement • Oct 19
PharmAust Limited, Annual General Meeting, Nov 20, 2023 PharmAust Limited, Annual General Meeting, Nov 20, 2023, at 14:00 E. Australia Standard Time. Location: the offices of RSM Australia Level 21, 55 Collins St, Melbourne Victoria Australia Agenda: To receive and consider the annual financial report of the Company for the financial year ended 30 June 2023 together with the declaration of the directors, the directors' report, the remuneration report and the auditor's report; to consider adoption of remuneration report; to consider re-election of Director - Dr. Roger Aston; to consider approval of additional 10% capacity; to consider approval to issue securities under employee incentive scheme; and to consider other matters. Reported Earnings • Sep 03
Full year 2023 earnings released: AU$0.019 loss per share (vs AU$0.005 loss in FY 2022) Full year 2023 results: AU$0.019 loss per share (further deteriorated from AU$0.005 loss in FY 2022). Revenue: AU$3.90m (down 14% from FY 2022). Net loss: AU$6.21m (loss widened 264% from FY 2022). Over the last 3 years on average, earnings per share has fallen by 37% per year but the company’s share price has only fallen by 31% per year, which means it has not declined as severely as earnings. New Risk • Aug 30
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended December 2022. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risk Share price has been highly volatile over the past 3 months (11% average weekly change). Minor Risks Latest financial reports are more than 6 months old (reported December 2022 fiscal period end). Shareholders have been diluted in the past year (10% increase in shares outstanding). Revenue is less than US$5m (AU$5.7m revenue, or US$3.7m). Market cap is less than US$100m (€16.2m market cap, or US$17.7m). Announcement • Aug 29
PharmAust Limited Announces Executive Changes PharmAust Limited announced the appointment of Dr Michael Thurn, PhD, as Chief Executive Officer (CEO). Dr Thurn will assume the role on 1 September 2023. Michael brings broad experience in drug discovery, development, regulation and commercialisation, acquired through leadership roles in research organizations and industry, including early-stage, fast-growing, private and publicly listed biotechnology companies. His previous responsibilities have included leading a variety of US Food and Drug Administration (FDA) Investigational New Drug (IND) applications across a range of therapeutic areas and the evaluation of drugs and vaccines for registration in Australia as a part of the Drug Safety Evaluation Branch (DSEB) of the Therapeutics Goods Administration (TGA). Michael has also been responsible for the execution of Phase 1 and 2 clinical trials and business development activities across animal and human health products. He possesses strong entrepreneurial, leadership and management skills that have seen him achieve outstanding results over a 25 year career in the biotechnology industry, including co-founding MARP Therapeutics and roles with Botanix Pharmaceuticals, Mimetica, Spinifex Pharmaceuticals, Cytopia, Xenome and Novogen. During this time, Michael has gained Australian and US capital markets exposure and has successfully accessed funding through private and public channels, partnerships and non-dilutive means. Dr Roger Aston will remain Chairman of the Board but will transition into a non-executive role assisting with his 40 years of experience in the pharmaceutical and healthcare industry. Announcement • Aug 28
PharmAust Limited Appoints Roger Aston as Non-Executive Chairman, Effective 1 September 2023 PharmAust Limited announced that Dr Roger Aston will remain Chairman of the Board but will transition into a non-executive role assisting with his 40 years of experience in the pharmaceutical and healthcare industry. Appointment: As Non-Executive Chairman. The appointment commences with effect on 1 September 2023 and continues until terminated in accordance with the agreement. Reported Earnings • Mar 03
First half 2023 earnings released: EPS: AU$0 (vs AU$0.004 loss in 1H 2022) First half 2023 results: EPS: AU$0 (improved from AU$0.004 loss in 1H 2022). Revenue: AU$2.91m (up 69% from 1H 2022). Net loss: AU$21.2k (loss narrowed 98% from 1H 2022). Over the last 3 years on average, earnings per share has increased by 17% per year but the company’s share price has remained flat, which means it is significantly lagging earnings. Announcement • Jan 21
PharmAust Limited Progresses to Elevated Doses in MND Patients PharmAust Limited announced Trial Safety Committee approval to progress with an escalation of the MPL tablet dosing for MND patients. The trial patients living with MND/Amyotrophic Lateral Sclerosis (MND/ALS) were evaluated for adverse events and pharmacokinetic information of MPL absorption. The Trial Safety Committee confirmed there were no reported safety issues or SAEs. The PK data also confirmed drug absorption. PharmAust will continue to supply MPL tablets to all six patients in Cohort 1 that elected to remain on the treatment. The trial is open label and comprises a four-week escalating dose of MPL. Patient recruitment at the next MPL dosing level has commenced with four new patients currently undergoing screening. PharmAust demonstrated in its preclinical programs that MPL has the potential to activate molecular pathways relevant to the treatment of MND. MPL could potentially reduce the rate of degeneration and loss of motor neurons in the anterior horns and motor nuclei of the brainstem. There are also a number of surrogate clinical endpoints to be determined during the trial. PharmAust has developed and manufactured a bespoke MPL tablet for the trial. Announcement • Jan 07
PharmAust Limited Completes First Cohort of Six Patients in Its Phase 1/2 Clinical Trial of Lead Drug Candidate Monepantel in Motor Neurone Disease/Amyotrophic Lateral Sclerosis PharmAust Limited has successfully complete its first cohort of six patients in its Phase 1/2 clinical trial of its lead drug candidate monepantel in Motor Neurone Disease/Amyotrophic Lateral Sclerosis. Having announced completion of patient recruitment for treatment level 1, PharmAust has now successfully completed the day 29 dosing of the final patient in the first cohort. The patients were enrolled at two sites: Calvary Health Care Bethlehem, Parkdale, Victoria and the Centre for Motor Neurone Disease Research, Faculty of Medicine and Health Research Macquarie University, Sydney. Importantly, all of the six patients in this first cohort have elected to continue on MPL treatment. The phase 1/2 clinical study is determining the tolerability, safety, pharmacokinetics and preliminary efficacy of oral MPL in MND sufferers. The trial is open label and comprises a four week escalating dose of MPL. The MPL tablets have been well tolerated by patients in the first cohort and the Safety Monitoring Committee will review data from each dosage level for safety and pharmacokinetics. The following dose level and cumulative data points will be reviewed as soon as possible for: Serious Adverse Events, Adverse Events, Safety blood results, ECG, Vital signs including temperature, blood pressure, and pulse, Pharmacokinetic results and Cerebrospinal Fluid . The progressive elevation of MPL levels, as progress the pharmacokinetic evaluation in MND, will be indicative of the safe dosing levels for planned COVID trial. In the current trial, levels of MPL are determined in serum after dosing over a 28-day period. Patient recruitment at the next dosing level of MPL is expected to begin later this month. According to the International Alliance of ALS/MND Associations, MND affects over 350,000 people globally and kills more than 100,000 people every year. The disease is invariably fatal, with the average life expectancy of someone who has MND being just around 27 months. The MND/ALS addressable market is $3.6 Billion per annum with Riluzole already reaching $1 Billion in annual sales. PharmAust demonstrated in its preclinical programs that MPL has the potential to activate molecular pathways relevant to the treatment of MND. MPL could potentially reduce the rate of degeneration and loss of motor neurons in the anterior horns and motor nuclei of the brainstem. There are also a number of surrogate clinical endpoints to be determined during the trial. PharmAust has developed and manufactured a bespoke monepantel tablet for the trial. This Phase1/2 study is being funded by a commitment of $881,085 made by FightMND, the larger independent funder of MND research in Australia. With success in the clinic PharmAust hopes that in due course MPL could receive orphan drug designation by the FDA for the indication of motor neurone disease. Such designations come with a number of financial and supportive benefits. Board Change • Nov 17
No independent directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 5 experienced directors. 2 highly experienced directors. No independent directors (4 non-independent directors). Non-Executive Director Neville Bassett was the last director to join the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of independent directors. Insufficient board refreshment. Reported Earnings • Aug 27
Full year 2022 earnings released: AU$0.005 loss per share (vs AU$0.004 loss in FY 2021) Full year 2022 results: AU$0.005 loss per share (down from AU$0.004 loss in FY 2021). Revenue: AU$4.51m (up 23% from FY 2021). Net loss: AU$1.71m (loss widened 28% from FY 2021). Over the last 3 years on average, earnings per share has increased by 11% per year but the company’s share price has fallen by 3% per year, which means it is significantly lagging earnings. Board Change • Apr 27
No independent directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 5 experienced directors. 2 highly experienced directors. No independent directors (4 non-independent directors). Non-Executive Director Neville Bassett was the last director to join the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of independent directors. Insufficient board refreshment. Reported Earnings • Feb 19
First half 2022 earnings: Revenues and EPS in line with analyst expectations First half 2022 results: AU$0.004 loss per share (down from AU$0.003 loss in 1H 2021). Revenue: AU$1.72m (down 3.3% from 1H 2021). Net loss: AU$1.23m (loss widened 48% from 1H 2021). Revenue was in line with analyst estimates. Over the last 3 years on average, earnings per share has increased by 16% per year but the company’s share price has increased by 65% per year, which means it is tracking significantly ahead of earnings growth. Reported Earnings • Aug 21
Full year 2021 earnings released: AU$0.004 loss per share (vs AU$0.005 loss in FY 2020) The company reported a soft full year result with weaker revenues and control over costs, although losses reduced. Full year 2021 results: Revenue: AU$3.67m (down 11% from FY 2020). Net loss: AU$1.34m (loss narrowed 1.8% from FY 2020). Over the last 3 years on average, earnings per share has increased by 40% per year whereas the company’s share price has increased by 44% per year. Reported Earnings • Sep 20
Full year earnings released - €0.0046 loss per share Over the last 12 months the company has reported total losses of AU$1.36m, with losses narrowing by 12% from the prior year. Total revenue was AU$4.12m over the last 12 months, down 5.2% from the prior year. 
