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). New Risk • Jan 06
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 25% This is considered a minor 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 Risk Earnings have declined by 59% per year over the past 5 years. Minor Risks Shareholders have been diluted in the past year (25% increase in shares outstanding). Revenue is less than US$5m (AU$1.5m revenue, or US$1.0m). Market cap is less than US$100m (AU$49.2m market cap, or US$33.1m). 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. New Risk • Mar 31
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of Australian stocks, typically moving 16% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$10m free cash flow). Share price has been highly volatile over the past 3 months (16% average weekly change). Earnings have declined by 50% per year over the past 5 years. Revenue is less than US$1m (AU$1.5m revenue, or US$953k). Minor Risks Shareholders have been diluted in the past year (25% increase in shares outstanding). Market cap is less than US$100m (AU$64.0m market cap, or US$40.2m). New Risk • Feb 18
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -AU$10m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$10m free cash flow). Earnings have declined by 52% per year over the past 5 years. Minor Risks Share price has been volatile over the past 3 months (14% average weekly change). Shareholders have been diluted in the past year (27% increase in shares outstanding). Revenue is less than US$5m (AU$1.7m revenue, or US$1.1m). Market cap is less than US$100m (AU$78.8m market cap, or US$50.1m). New Risk • Jan 31
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Australian stocks, typically moving 12% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 38% per year over the past 5 years. Revenue is less than US$1m (AU$842k revenue, or US$523k). Minor Risks Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (28% increase in shares outstanding). Market cap is less than US$100m (AU$61.5m market cap, or US$38.2m). 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 New Risk • Jan 30
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Australian stocks, typically moving 13% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Earnings have declined by 12% per year over the past 5 years. Minor Risks Share price has been volatile over the past 3 months (13% average weekly change). Shareholders have been diluted in the past year (21% increase in shares outstanding). Revenue is less than US$5m (AU$3.8m revenue, or US$2.5m). Market cap is less than US$100m (AU$75.1m market cap, or US$49.5m). 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. New Risk • Sep 02
New major risk - Revenue and earnings growth Earnings have declined by 12% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risk Earnings have declined by 12% per year over the past 5 years. Minor Risks Shareholders have been diluted in the past year (10% increase in shares outstanding). Revenue is less than US$5m (AU$3.9m revenue, or US$2.5m). Market cap is less than US$100m (AU$26.2m market cap, or US$16.9m). Reported Earnings • Sep 02
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 27% 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: 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 (AU$27.9m market cap, or US$18.1m). 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. Announcement • Dec 03
PharmAust Limited Announces MND Trial Completes Enrolment of First Patient Cohort PharmAust Limited provided an update on its Phase 1/2 clinical trial of its lead drug candidatemonepantel (MPL) in Motor Neurone Disease/Amyotrophic Lateral Sclerosis (MND/ALS). PharmAust, the trial sponsor, is pleased to advise that the trial has completed enrolment of the firstcohort of six patients. The patients are 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, New South Wales. The final patient for the cohort was dosed and replaces a patient who was excluded as they failed to comply with enrolment requirements. The phase 1/2 clinical study is aimed at determining the tolerability, safety, pharmacokinetics and preliminary efficacy of oral MPL in individuals living with MND. 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 of the trial and the Safety Monitoring Committee will review data from each Dosage Level for continued safety and pharmacokinetic data up to cycle. The following dose level and cumulative data points (where available) will be reviewed as soon aspossible (approximately 19 working days) after the last participant in the cohort completes Day 29 for: Serious Adverse Events (SAEs); Adverse Events (AEs); Safety blood results (haematology, chemistry, urinalysis); ECG; Vital signs including temperature, blood pressure, and pulse; and Pharmacokinetic results (PK and CSF). The progressive elevation of MPL levels, as company progress the pharmacokinetic evaluation in MND will facilitate the determination of safe dosing levels for COVID trial to be undertaken next year. In the current trial, levels of MPL are determined in serum after dosing over a 28-day period. Board Change • Nov 16
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. Announcement • Sep 30
PharmAust Limited, Annual General Meeting, Nov 10, 2022 PharmAust Limited, Annual General Meeting, Nov 10, 2022, at 16:00 W. Australia Standard Time. Location: RSM Australia, Level 32, 2 The Esplanade Perth Western Australia Australia Agenda: To receive and consider the annual financial report of the Company for the financial year ended 30 June 2022 together with the declaration of the directors, the directors' report, the remuneration report and the auditor's report; to consider reelections of directors; to consider approval of additional 10% capacity; and to consider rother matters. Announcement • Sep 07
PharmAust Limited Recruits First Pet Dog with B Cell Lymphoma in US Canine Phase 2 Trial Assessing the Efficacy of Monepantel Treatment PharmAust Limited has recruited the first pet dog with B cell lymphoma in its US canine Phase 2 trial assessing the efficacy of Monepantel treatment. Dr Meighan Daly DeHart and the medical oncology team at Pathway Vet Alliance dba as Thrive Pet Healthcare and Heart of Texas Veterinary Specialty Center in the US will treat up to 10 dogs according to FDA pilot program guidelines. Within the last week the first dog passed a physical exam and standardised staging tests and was sent home to commence treatment with MPL tablets. The dog will be required to return for appraisal on Days 14 and 28 at Heart of Texas with Dr Daly DeHart. Veterinary trial centres have been set up in Australia, New Zealand and the United States to evaluate the anti-cancer benefit of MPL in dogs newly diagnosed with B-cell lymphoma and have not received any previous cancer treatment. PharmAust is recruiting pet dogs with untreated B cell lymphoma to finalise the Phase 2 evaluation of the drug MPL, which has demonstrated effective anti-cancer activity and minimal side effects. Twenty-nine pet dogs have been treated using MPL monotherapy. With continued positive outcomes, PharmAust is preparing for a successful Phase 2 completion and the commencement of a subsequent Phase 3 registration trial. Of the 16 pet dogs with optimum blood levels, 13 have achieved stable target lesions. This includes one dog with a partial response. Nine of the 16 dogs with optimum blood levels have achieved stable disease by RECIST. Side effects were minimal or not detected. PharmAust requires greater than or equal to 18 dogs with a clinical benefit out of 46 dogs to meet its statistical endpoint. MPL is already approved for veterinary use for a different indication in food-chain animals. PharmAust is endeavouring to repurpose MPL as a safe and effective cancer treatment without the associated side effects of chemotherapy. 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 7% per year, which means it is significantly lagging earnings. Announcement • Aug 18
Pharmaust Updates on Canine Cancer Trials PharmAust Limited provided this update on its canine cancer trials. Significant progress has occurred in the clinical trials of its primary drug candidate Monepantel (MPL). Veterinary trial centres have been set up in Australia, New Zealand and the United States to evaluate the anti-cancer benefit of MPL in dogs newly diagnosed with B-cell lymphoma and have not received any previous cancer treatment. MPL is already approved for veterinary use for a different indication in food-chain animals. PharmAust is endeavouring to repurpose MPL as a safe and effective cancer treatment without the associated side effects of chemotherapy. Following early Phase 2 success in Australia with MPL, and in preparation for registration trials, PharmAust is now also recruiting canine patients in New Zealand and expects the first enrolment in the US trial site this month. Five dogs have already been successfully recruited in New Zealand. Twenty-seven pet dogs have been treated using MPL monotherapy. With continued positive outcomes PharmAust is preparing for a successful Phase 2 completion and the commencement of a subsequent Phase 3 registration trial. Of the 16 pet dogs with optimum blood levels, 13 have achieved stable target lesions. This includes one dog with a partial response (60% regression). Nine of the 16 dogs with optimum blood levels have achieved stable disease by RECIST (Response Evaluation Criteria in Solid Tumours). Side effects were minimal or not detected. PharmAust requires greater than or equal to 18 dogs with a clinical benefit out of 46 dogs to meet its statistical endpoint. Announcement • May 29
PharmAust Limited Announces Resignation of Richard Mollard as Chief Scientific Officer PharmAust Limited advises that Chief Scientific Officer of PharmAust Ltd. and Chief Executive Officer of PharmAust's fully owned subsidiary Pitney Pharmaceuticals Pty Ltd, Dr. Richard Mollard, has tendered his resignation and given the Company six months' notice as required under his contract. Dr. Mollard has been with PharmAust for five years and, during this time, he has played an important role in establishing and undertaking many activities on behalf of the Company. The Company will consider the optimal way to resource and undertake future steps in furtherance of the Company's different projects, and this may include identifying several resources for the different projects. Announcement • May 18
Pharmaust Limited Announces Arrival of Mpl Tablets in Melbourne for Motor Neuron Disease Clinical Trial PharmAust Limited announced the arrival of its cGMP (current Good Manufacturing Practice) grade monepantel (MPL) tablets specifically designed for the MND trial in Melbourne. The trial is being funded with support from FightMND. The cGMP MPL tablets for MND were designed with a different shape and size to help swallowing by MND patients and to reach specific blood drug levels targeted for this disease. Pre-release technical specifications of the MPL tablets demonstrate that stability specification required for the trial is achieved and PharmAust is now awaiting signed technical documentation from the manufacturer. Paperwork for shipment of the contingency/back-up second consignment is completed and these MPL tablets are on route with expected arrival later this week. Auxiliary preparations for MND trial commencement are mostly complete except for some technical and regulatory sign-offs and characterisation of a minor impurity in the tablet, all expected to be finalised prior to the end of May. Recruitment cannot commence until final governance signature, as this is when the Clinical Trials Notification Licence with the Therapeutics Goods Administration becomes activated. Announcement • May 12
PharmAust Limited Expands Lymphoma Canine Trial to the USA PharmAust Limited announce an agreement with Pathway Vet Alliance dba as Thrive Pet Healthcare and Heart of Texas (HoT) Veterinary Specialty Centre in the USA to join the MPL pet dog B cell lymphoma trial. PharmAust will send sufficient tablets for HoT to treat up to 10 dogs according to FDA pilot program guidelines. This US expansion builds on PharmAust's new trial site in New Zealand. The New Zealand site recently completed its first 28 day treatment of a dog with B cell lymphoma for a successful trial outcome. Trial recruitment continues in Australia with PharmAust successfully fulfilling interim Phase 2 trial endpoints. 25 pet dogs have now been treated using MPL monotherapy. With continued positive outcomes, PharmAust is preparing for a successful Phase 2 completion and the commencement of a subsequent registration trial. In addition to the trial MPL monotherapy, eight dogs have now been treated post-trial using ongoing MPL in combination with standard of care prednisolone. This MPL and prednisolone combination has to date provided median and average survival times of approximately 140 days or 20 weeks. This compares favourably with the eight to nine week median and average survival times expected for dogs with B cell lymphoma treated with prednisolone alone. Furthermore, high qualities of life for dogs and their owners have been reported on this combination treatment. 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. Announcement • Feb 24
PharmAust Limited Announces Preliminary MPL Anti-Viral Leukaemia Preclinical WEHI Results PharmAust Limited provided an update on the Walter and Eliza Hall Institute (WEHI) investigation of the anti-viral effects of monepantel (MPL) upon human T-cell Leukaemia Virus-1 (HTLV-1) in vitro. WEHI demonstrated that MPL and MPLS can kill HTLV-1-transformed leukaemia cell lines and inhibit HTLV-1 protein production, as measured by in vitro assays. The ability of MPL to induce cell death of HTLV-1 transformed cells is greater than that in a control non-transformed cell line (Jurkat). These data performed in triplicate indicate that MPL may interfere with the complex HTLV-1 lifecycle. Further investigation using pre-clinical models may be warranted to understand the mechanism of action, and ability of MPL to slow disease progression. This work supports PharmAust's broader program investigating the anti-viral effect of MPL for other pathogens such as SARS-CoV-2. Reported Earnings • Feb 20
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 48% per year, which means it is tracking significantly ahead of earnings growth. Announcement • Feb 02
PharmAust Limited Provides Update on Manufacture of MPL & Tablets for Clinical Trials PharmAust Limited provides this update on its manufacturing program for the active pharmaceutical ingredient (API) and the formulation and preparation of tablets for clinical trials in humans. Following feedback from its manufacturing partners PharmAust is on schedule to meet the nominated clinical trial deadlines with the first patient due to be recruited for the Phase I/II human trial in motor neurone disease (MND) by the end of May 2022. Monepantel manufacturing is scheduled for completion mid-February 2022. The API product will then be shipped to the US for formulation and tableting. Tabletting is scheduled for completion mid-March 2022. Implementation of a successful accelerated stability program mid-April should enable the release of finished product in May 2022. Throughout the manufacturing and development process PharmAust has focussed on developing a high purity specification for the product, suitable for both human and veterinary purposes. The Company has also created a unique manufacturing process to optimise yields, purity and shelf-life stability. Protocols and ethics/regulatory approvals are now in place for the evaluation of monepantel in motor neurone disease. The trial will test safety and tolerability in patients living with MND and look for signs that monepantel can slow its progression. Reported Earnings • Aug 22
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 36% per year. Announcement • Jun 30
Pharmaust Limited Achieves Phase IIB Dog Trial's Interim Clinical Endpoints PharmAust Limited announced that following the treatment of 15 pet dogs during its Phase IIa and Phase IIb studies, monepantel (MPL) demonstrated sufficient and statistically significant anti-cancer activity to continue development into Phase III. Multi-centric hig h grade B-cell lymphoma is one of the more aggressive cancers to study in canine oncology. Objective regression in one of the first eight dogs, with some tumours resolving completely, as well as objective stable disease or better in six of the first 15 pet dogs treated over the 28 day trial is a compelling outcome. Two pet dogs with advanced and extensively disseminated disease and one other dog with advanced and less extensively disseminated disease were treated with lower dose MPL, however, these were withdrawn due to disease progression during the trial. The remaining 12 treated pet dogs completed the full 28 day trial period. Published mean and median times for untreated dogs show that normally eight of these 15 pet dogs would have been euthanised by day 29/30 with aggressively progressive disease and poor quality of life1. Comprehensive data are not available ex-trial, but available reports are that at least six pet dogs continued with either MPL alone or in combination with prednisolone. The inappetence and elevated liver enzymes observed at the higher doses of MPL will not be relevant for Phase III. This Phase IIb trial also opens the door for PharmAust and its team of vets to explore the value of MPL in other canine cancers. MPL's ability to target a central metabolic pathway associated with tumour
growth (mTOR) provides confidence that MPL will have application in other cancers. Furthermore, having evaluated a range of treatment regimens for MPL during the current trial, the Company has established a therapeutic window for clinical trials in human cancers. Achieving stable disease in primary cancerous lesions as well as in metastatic disease could have substantial value in human cancer therapy particularly if progression-free survival correlates with overall survival. It is noteworthy that achievement of stable disease was observed in PharmAust's previous small Phase I trial in humans where the participants had been admitted with progressive disease following the failure of other treatments. Announcement • Jun 02
PharmAust Receives Ethics Approval for Phase I Trial of Monepantel in Motor Neurone Disease PharmAust Limited will proceed with a new Phase I clinical trial in humans to assess monepantel (MPL) in patients with amyotrophic lateral sclerosis/motor neurone disease (ALS/MND). This trial will be funded and conducted in collaboration with FightMND, Calvary HealthCare Bethlehem (Melbourne) and Macquarie University (Sydney). ALS/MND is a group of diseases that affect nerve cells controlling vital everyday functions including movement and breathing. ALS/MND is rare and invariably fatal (~140,000 new patients worldwide per annum) and imposes a high burden on patients, their families and carers, and carries substantial socio-economic costs. Two Australians will be diagnosed with MND every day with a life-time risk of developing MND of 1 in 300. The average life expectancy with MND is just 27 months. There is a great need for better treatments to prolong life and improve therapy. PharmAust has already shown in its preclinical programs that MPL has the potential to activate molecular pathways relevant to the treatment of MND. If effective, MPL would reduce the rate of degeneration and loss of motor neurons in the anterior horns and motor nuclei of the brainstem. Furthermore, there are a number of surrogate clinical endpoints that will also be determined during the trial. For the purpose, PharmAust is developing and manufacturing a bespoke monepantel tablet for the trial. Monash Health Human Research Ethics Committee (HREC) has approved the monepantel (MPL) clinical trial protocol. Announcement • Apr 28
PharmAust Limited Announces Phase IIb Canine Trial Identifies Therapeutic Window for MPL PharmAust Limited announced that interim analysis of its Phase IIb trial has provided further supportive evidence of the monepantel blood plasma levels required to suppress B cell lymphoma growth in pet owners' dogs. PharmAust is now in a good position to further optimise treatment levels of MPL to facilitate a Phase III study. Monepantel in this stage of the study indicated no material adverse events. Announcement • Feb 16
PharmAust Ltd Provides an Update on Phase IIb Trial Testing the Effects of Monepantel Upon Pet Owners' Dogs with Treatment Naïve B Cell Lymphoma PharmAust Ltd. provided an update on its Phase IIb trial testing the effects of monepantel upon pet owners' dogs with treatment naïve B cell lymphoma. Recruitment for the trial has commenced and several dogs have been successfully recruited and have started treatment with MPL tablets. Six dogs not eligible for the trial have commenced compassionate treatment with MPL tablets. PharmAust will be pleased to update the market when a sufficient number of dogs with meaningful trial endpoints have completed their treatment regimen. Announcement • Feb 10
PharmAust Limited Announces Monepantel COVID-19 Testing in the Netherlands PharmAust Ltd. provided further information on work being conducted in the Netherlands investigating the effects of monepantel upon coronavirus infections. The coronavirus pandemic has been severely affecting global supply chains and consequently performing experiments in many parts of the world, including the Netherlands, has proven problematic. Tests using monepantel and monepantel sulfone as Covid-19 antivirals, however, continue at Leiden University and PharmAust will be pleased to update the market when results come to hand. Announcement • Jan 09
PharmAust and Leiden University Medical Centre Provide Update on Monepantel COVID-19 Testing PharmAust Ltd. announced that it is working closely with Dr Martijn van Hemert at Leiden University Medical Centre (LUMC) in the Netherlands as more research is being undertaken at LUMC to increase the solubility of MPL, as a precursor to MPL demonstrating applicability against coronavirus. This involves finding conditions that are compatible with the highly specialised assays and coronavirus culture conditions for testing MPL. These assays and this development program are crucial for later performing work in more advanced human airway systems. Combining the conditions required for the specialised cell-based assays at LUMC with the highly insoluble nature and unique features of MPL, means the standard assays used for other compounds require a unique high level of optimisation in MPL testing. As announced on 28 May 2018, PharmAust successfully reformulated monepantel (MPL) from
a liquid product to a tablet. As announced on 17 October 2017, part of the challenge in reformulation was addressing the poorly soluble nature of MPL in water. PharmAust's clinical research plans, however, remain on track. As announced on 23 December 2020, MPL manufacture in preparation for research and development in Phase 1/2 clinical trials is ongoing with trials remaining due to commence later in CY 2021. Announcement • Jan 06
PharmAust and Olivia Newton-John Cancer Research Institute to Continue MPL Pre-clinical Investigations PharmAust announced an agreed extension of work being conducted at the Olivia Newton-John Cancer Research Institute (ONJCRI) investigating the mechanism of action of monepantel (MPL) upon cancer cells. As announced on 29 September 2020, researchers in the Cell Death and Survival Laboratory at the ONJCRI led by Associate Professor Doug Fairlie conducted a comprehensive RNA-Seq (RNA sequencing) screen investigating how the entire genome of cancer cells responds when treated with MPL. A select subset of genes was found to be either switched on or off by MPL in cancer cells, but not in non-cancer cells. The mRNA profiles of non-cancer cells were relatively unaffected by MPL treatment, consistent with the possible low level of toxicology observed for MPL. Using state-of-the-art techniques, the ONJCRI researchers will now examine these genes in greater detail and match changes in their activity with changes in associated protein signalling pathways. These experiments are aimed at determining what happens within the cancer cell once MPL interacts with its primary molecular targets and then exerts its downstream and definitive anti-cancer activity. Establishing MPL's mechanism of action in this detail will enable differentiation of MPL's effects upon cancer cells as compared to other anti-cancer drugs, thus assisting with regulatory submissions and facilitating licensing and marketing as the company move towards Phase III and IV trials. The work to be conducted by the ONJCRI will be funded by PharmAust. Announcement • Dec 23
PharmAust Ltd to Commence Phase IIb Dog Cancer Trial PharmAust Ltd. announced receipt of ethics approvals from the New South Wales Department of Primary Industry (DPI) and Queensland Department of Agriculture and Fisheries (DAF) to undertake a Phase IIb clinical trial in pet owners' dogs with cancer using its newly formulated tablet. This continuation of the original Phase IIa trial is aimed at demonstrating high efficacy at reduced MPL plasma levels as well as alleviating the inappetence observed in the previous trial iteration. The approvals cover recruitment at five sites in Sydney, Perth and Brisbane. Another two sites previously involved in the trial await approvals following reconvening of respective ethics committees after the Christmas period. As announced on 12 May 2020, the company recently completed studies testing the effects of MPL tablets upon six pet owners' dogs with treatment naïve B cell lymphoma over a 28 day period. MPL tablets were administered daily at a high target dose and the prospectively nominated objective response criteria for demonstrating anticancer activity were met. All pet dogs achieved stable disease of their target cancer lesions. Despite this success, the trial was terminated early because most but not all dogs developed some inappetence. Of note, all pet dogs had a common high MPL target dose, yet some pet dogs on trial achieved relatively low drug blood levels. The pet dog with the lowest drug blood levels achieved an objective anticancer response with a 60% reduction in cancer burden, with some cancer lesions disappearing. The company has scrutinised trial data to understand drug blood level variation and importantly has developed a new dosing methodology that aims to achieve the lower drug blood levels that equated with highest anticancer activity. The trial continuation will involve the same duration and readouts, but just the dosing regimen will be modified. Announcement • Oct 03
PharmAust Limited Provides an Update on Analysis at the Olivia Newton-John Cancer Research Institute Investigating the Mechanism of Action of Monepantel Upon Cancer Cells PharmAust Limited provided an update on analysis at the Olivia Newton-John Cancer Research Institute (ONJCRI) investigating the mechanism of action of monepantel (MPL) upon cancer cells. Researchers in the Cell Death and Survival Laboratory at the ONJCRI conducted an RNA sequencing screen comprehensively investigating how the entire genome of cancer cells respond when treated with MPL. In particular, this approach identifies which genes are switched-on and which genes are switched-off by MPL. One non-cancer cell line was used as control and the three cancer cell lines were melanoma, lung cancer and ovarian cancer. The ONJCRI researchers found that changes in gene expression in the non-cancer cell genome were relatively modest when compared to the changes in the three cancer cell lines. This observation supports previous studies indicating that MPL does not affect non-cancer cells and has selectivity towards cancer cells. Particularly, the ONJCRI demonstrated that cancer cell genes involved in promoting cell division were supressed, while those involved in inducing cell death (apoptosis) or autophagy were induced. These observations are consistent with other data showing that MPL acts to stop cancer cells from dividing and to self-destruct. A number of genes identified from this screen will now be investigated further to establish the mechanism of action of MPL and to enable differentiation of MPL's effects on cancer cells compared to other anti-cancer drugs. The work by the ONJCRI is supported in part by a $50,000 Innovation Connections grant from the Commonwealth Department of Industry, Innovation and Science. Announcement • Sep 24
Pharmaust Ltd, Entered into A Service Agreement with Leiden University Medical Center (Lumc) in Netherlands for Lumc to Test PharmAust Ltd, has entered into a Service Agreement with Leiden University Medical Center (LUMC) in the Netherlands for LUMC to test the effects of monepantel and monepantel sulfone on the replication of SARS-CoV-2 in cell lines. The purpose is to determine their applicability for testing these compounds in ex-vivo human SARS-CoV-2 infection models (cultured human airway epithelial tissue). The Agreement provides that PharmAust will pay a fee to LUMC and will own all intellectual property results generated from the study. Reported Earnings • Sep 19
Full year earnings released - AU$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.