New Risk • May 19
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: AU$11.4m (US$8.10m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (21% average weekly change). Earnings have declined by 29% per year over the past 5 years. Shareholders have been substantially diluted in the past year (44% increase in shares outstanding). Revenue is less than US$1m (AU$214k revenue, or US$152k). Market cap is less than US$10m (AU$11.4m market cap, or US$8.10m). New Risk • Mar 21
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: AU$14.2m (US$9.99m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (29% average weekly change). Earnings have declined by 29% per year over the past 5 years. Shareholders have been substantially diluted in the past year (61% increase in shares outstanding). Revenue is less than US$1m (AU$214k revenue, or US$150k). Market cap is less than US$10m (AU$14.2m market cap, or US$9.99m). Ankündigung • Feb 16
Memphasys Limited has completed a Follow-on Equity Offering in the amount of AUD 0.8 million. Memphasys Limited has completed a Follow-on Equity Offering in the amount of AUD 0.8 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 160,000,000
Price\Range: AUD 0.005
Discount Per Security: AUD 0.0003
Transaction Features: Subsequent Direct Listing Ankündigung • Feb 06
Memphasys Limited has filed a Follow-on Equity Offering in the amount of AUD 0.8 million. Memphasys Limited has filed a Follow-on Equity Offering in the amount of AUD 0.8 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 160,000,000
Price\Range: AUD 0.005
Discount Per Security: AUD 0.0003
Transaction Features: Subsequent Direct Listing Ankündigung • Dec 30
Memphasys Limited has completed a Follow-on Equity Offering in the amount of AUD 1.120549 million. Memphasys Limited has completed a Follow-on Equity Offering in the amount of AUD 1.120549 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 180,460,810
Price\Range: AUD 0.003
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 193,055,540
Price\Range: AUD 0.003
Security Features: Attached Options
Transaction Features: Rights Offering New Risk • Nov 12
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 39% 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 Share price has been highly volatile over the past 3 months (33% average weekly change). Earnings have declined by 34% per year over the past 5 years. Shareholders have been substantially diluted in the past year (39% increase in shares outstanding). Revenue is less than US$1m (AU$527k revenue, or US$344k). Market cap is less than US$10m (AU$9.82m market cap, or US$6.41m). Board Change • Nov 01
High number of new and inexperienced directors There are 3 new directors who have joined the board in the last 3 years. The company's board is composed of: 3 new directors. No experienced directors. No highly experienced directors. Independent Non-Executive Chairperson of the Board Lindley Edwards is the most experienced director on the board, commencing their role in 2024. The company’s lack of experienced directors is considered a risk according to the Simply Wall St Risk Model. Ankündigung • Oct 21
Memphasys Limited, Annual General Meeting, Nov 20, 2025 Memphasys Limited, Annual General Meeting, Nov 20, 2025. Location: at level 32, 200 george street, sydney nsw 2000 Australia Ankündigung • Oct 20
Memphasys Limited Announces Board Changes, Effective 20 October 2025 Memphasys Limited announced that Dr. David Ali will step down as Executive Director effective 20 October 2025. Dr. Ali will continue in his role as Chief Executive Officer (CEO), with a dedicated focus on the operational and executional aspects of the business as the Company advances the commercialisation of the FelixTM System. This change reflects Memphasys' strategic pivot toward commercialisation, marking a transition from product development to global market rollout. With multiple distribution agreements progressing and CE marking expected in early 2026, operational discipline and execution have become central to the Company's success. Concentrating Dr. Ali's focus solely on operations will ensure optimal delivery against these commercial milestones. As part of this evolution, Mr. Marjan Mikel has assumed the role of Chair of Commercialisation, overseeing strategy, partnerships, and market expansion initiatives. This reinforces the Company's commitment to disciplined growth, partnership-driven scaling, and commercial excellence. The company also announced the appointment of Mr. Mathew Watkins as an Independent Non- Executive Director, effective 20 October 2025. Mr. Watkins is a Chartered Accountant and member of the Governance Institute of Australia with extensive ASX experience across biotechnology, bioscience, resources, and information technology sectors. He specialises in ASX statutory reporting, compliance, corporate governance, and board and secretarial support. Mr. Watkins serves as Company Secretary for several ASX-listed entities and is currently the SEA Regional Practice Lead & Australia Market Lead at Vistra (Australia) Pty Ltd. Reported Earnings • Oct 05
Full year 2025 earnings released: AU$0.003 loss per share (vs AU$0.004 loss in FY 2024) Full year 2025 results: AU$0.003 loss per share (improved from AU$0.004 loss in FY 2024). Net loss: AU$5.04m (loss narrowed 6.2% from FY 2024). Over the last 3 years on average, earnings per share has remained flat but the company’s share price has fallen by 39% per year, which means it is significantly lagging earnings. Ankündigung • Oct 04
Memphasys Limited has filed a Follow-on Equity Offering in the amount of AUD 1.120549 million. Memphasys Limited has filed a Follow-on Equity Offering in the amount of AUD 1.120549 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 373,516,350
Price\Range: AUD 0.003
Transaction Features: Rights Offering Ankündigung • Sep 23
Memphasys Limited has completed a Follow-on Equity Offering in the amount of AUD 0.8925 million. Memphasys Limited has completed a Follow-on Equity Offering in the amount of AUD 0.8925 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 297,500,000
Price\Range: AUD 0.003
Discount Per Security: AUD 0.00018
Transaction Features: Subsequent Direct Listing Reported Earnings • Aug 31
Full year 2025 earnings released Full year 2025 results: Net loss: AU$4.94m (loss widened 11% from FY 2024). Board Change • Jun 26
Less than half of directors are independent There are 4 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: 4 new directors. 1 experienced director. No highly experienced directors. 2 independent directors (3 non-independent directors). Independent Non-Executive Director Paul Wright is the most experienced director on the board, commencing their role in 2020. Independent Non-Executive Director Michael Atkins was the last independent director to join the board, commencing their role in 2024. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of experienced directors. Ankündigung • Jun 20
Memphasys Limited Appoints Marjan Mikel as Non-Executive Director Memphasys Limited announced the appointment of Mr. Marjan Mikel as a Non-Executive Director of the Company, effective immediately. Mr. Mikel brings a strong and diverse track record in business development, commercial leadership, capital markets, and strategic partnership execution across the Medtech, diagnostics, healthcare services, and life sciences sectors. He has held senior executive and board positions in both listed and private companies, with extensive experience in the commercialization of disruptive technologies and scaling ventures in regulated markets. He is currently the CEO and Managing Director of Vitasora Health Limited, an ASX-listed remote patient monitoring company operating in the U.S. healthcare system. Under his leadership, the company has pioneered the commercialization of a novel respiratory monitoring device and successfully transitioned into a full-service RPM provider. Mr. Mikel led capital raises, secured major U.S. ACO and payer contracts, and executed the cross-border acquisition of U.S.-based Orb Health, expanding the company's footprint and capabilities in the U.S. market. Previously, Mr. Mikel founded Healthy Sleep Solutions, building it into Australia's largest sleep health provider before securing ResMed as a strategic investor and leading a successful trade sale to global multinational Air Liquide. He also held senior commercial roles with IMS Health, Merck Sharp & Dohme, Pharmacia, and Searle, with responsibilities across Australia, Asia-Pacific, and Europe. Importantly, Mr. Mikel is familiar with Memphasys and its strategic vision, having previously served as a Non-Executive Director of the Company from June 2018 to March 2020, including as Chair of both the Audit & Risk Committee and the Nomination & Remuneration Committee. Mr. Mikel holds a Master of Commerce from the University of New South Wales, a Graduate Diploma in Education, and a Bachelor of Science (Hons) from the University of Sydney and has completed executive studies at the Australian Graduate School of Management. He is also a Member of the Australian Institute of Company Directors (MAICD). New Risk • Apr 22
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 45% 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 Share price has been highly volatile over the past 3 months (25% average weekly change). Earnings have declined by 34% per year over the past 5 years. Shareholders have been substantially diluted in the past year (45% increase in shares outstanding). Revenue is less than US$1m (AU$1.1m revenue, or US$690k). Market cap is less than US$10m (AU$9.92m market cap, or US$6.37m). Ankündigung • Apr 17
Memphasys Limited has completed a Follow-on Equity Offering in the amount of AUD 1.2755 million. Memphasys Limited has completed a Follow-on Equity Offering in the amount of AUD 1.2755 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 212,583,334
Price\Range: AUD 0.006
Security Features: Attached Options
Transaction Features: Subsequent Direct Listing Ankündigung • Apr 10
Memphasys Limited has filed a Follow-on Equity Offering in the amount of AUD 1.275 million. Memphasys Limited has filed a Follow-on Equity Offering in the amount of AUD 1.275 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 212,500,000
Price\Range: AUD 0.006
Transaction Features: Subsequent Direct Listing New Risk • Mar 01
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$3.6m 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$3.6m free cash flow). Share price has been highly volatile over the past 3 months (24% average weekly change). Earnings have declined by 34% per year over the past 5 years. Revenue is less than US$1m (AU$1.1m revenue, or US$665k). Market cap is less than US$10m (AU$14.2m market cap, or US$8.79m). Minor Risk Shareholders have been diluted in the past year (29% increase in shares outstanding). New Risk • Dec 27
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 57% 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 Share price has been highly volatile over the past 3 months (23% average weekly change). Earnings have declined by 33% per year over the past 5 years. Shareholders have been substantially diluted in the past year (57% increase in shares outstanding). Revenue is less than US$1m (AU$1.1m revenue, or US$678k). Market cap is less than US$10m (AU$10.6m market cap, or US$6.61m). Ankündigung • Sep 25
Memphasys Limited, Annual General Meeting, Oct 25, 2024 Memphasys Limited, Annual General Meeting, Oct 25, 2024. Location: level 1, 34-36 richmond road, homebush west nsw 2140, Australia New Risk • Sep 04
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 51% 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 Share price has been highly volatile over the past 3 months (20% average weekly change). Earnings have declined by 33% per year over the past 5 years. Shareholders have been substantially diluted in the past year (51% increase in shares outstanding). Revenue is less than US$1m (AU$1.3m revenue, or US$854k). Market cap is less than US$10m (AU$13.0m market cap, or US$8.72m). Reported Earnings • Aug 31
Full year 2024 earnings released Full year 2024 results: Net loss: AU$4.44m (loss widened 31% from FY 2023). Ankündigung • Aug 30
Memphasys Limited has completed a Follow-on Equity Offering in the amount of AUD 0.5 million. Memphasys Limited has completed a Follow-on Equity Offering in the amount of AUD 0.5 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 62,500,000
Price\Range: AUD 0.008
Security Features: Attached Options
Transaction Features: Subsequent Direct Listing Ankündigung • Jul 29
Memphasys Limited announced that it has received AUD 0.5 million in funding Memphasys Limited entered into a subscription agreement with Andrew Goodall for issuance of 62,500,000 common shares at a price of AUD 0.008 per share for gross proceeds of AUD 500,000 on July 29, 2024. New Risk • Feb 27
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$3.8m 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$3.8m free cash flow). Share price has been highly volatile over the past 3 months (20% average weekly change). Earnings have declined by 31% per year over the past 5 years. Revenue is less than US$1m (AU$656k revenue, or US$430k). Market cap is less than US$10m (AU$12.3m market cap, or US$8.06m). Minor Risk Shareholders have been diluted in the past year (43% increase in shares outstanding). Ankündigung • Jan 10
Memphasys Limited, Annual General Meeting, Feb 14, 2024 Memphasys Limited, Annual General Meeting, Feb 14, 2024, at 10:00 AUS Eastern Standard Time. Location: 30 Richmond Road, Homebush West New South Wales Australia Agenda: To consider APPROVAL OF ISSUE OF SHARES TO PETERS INVESTMENTS ON CONVERSION OF CONVERTIBLE NOTES; to consider APPROVAL TO ISSUE OPTIONS FREE ATTACHING TO PLACEMENT SHARES; to consider APPROVAL TO ISSUE SHARES AND OPTIONS TO RELATED PARTY UNDER THE PLACEMENT ON CONVERSION OF SHORT-TERM LOANS MR ANDREW GOODALL; and to discuss other matters. New Risk • Dec 13
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 18% 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 Risks Share price has been highly volatile over the past 3 months (26% average weekly change). Earnings have declined by 28% per year over the past 5 years. Revenue is less than US$1m (AU$624k revenue, or US$410k). Market cap is less than US$10m (AU$14.7m market cap, or US$9.64m). Minor Risk Shareholders have been diluted in the past year (18% increase in shares outstanding). Ankündigung • Dec 04
Memphasys Limited has filed a Follow-on Equity Offering in the amount of AUD 4.232268 million. Memphasys Limited has filed a Follow-on Equity Offering in the amount of AUD 4.232268 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 210,000,000
Price\Range: AUD 0.01
Discount Per Security: AUD 0.0006
Security Features: Attached Options
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 213,226,752
Price\Range: AUD 0.01
Discount Per Security: AUD 0.0006
Security Features: Attached Options
Transaction Features: Rights Offering; Subsequent Direct Listing Reported Earnings • Sep 01
Full year 2023 earnings released: AU$0.002 loss per share (vs AU$0.003 loss in FY 2022) Full year 2023 results: AU$0.002 loss per share. Net loss: AU$3.40m (loss widened 63% from FY 2022). Ankündigung • Aug 31
Memphasys Limited, Annual General Meeting, Nov 22, 2023 Memphasys Limited, Annual General Meeting, Nov 22, 2023, at 11:00 E. Australia Standard Time. Location: 30 Richmond Road, 2140 Homebush West New South Wales Australia New Risk • Aug 27
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 Risks Less than 1 year of cash runway based on free cash flow trend (-AU$2.8m free cash flow). Share price has been highly volatile over the past 3 months (18% average weekly change). Earnings have declined by 22% per year over the past 5 years. Revenue is less than US$1m (AU$72k revenue, or US$46k). Market cap is less than US$10m (AU$15.4m market cap, or US$9.84m). 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). New Risk • Jun 09
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: AU$14.4m (US$9.66m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. 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$2.8m free cash flow). Earnings have declined by 22% per year over the past 5 years. Revenue is less than US$1m (AU$72k revenue, or US$48k). Market cap is less than US$10m (AU$14.4m market cap, or US$9.66m). Minor Risks Share price has been volatile over the past 3 months (15% average weekly change). Shareholders have been diluted in the past year (21% increase in shares outstanding). Ankündigung • Feb 07
Memphasys Limited Announces the First Publications of Study Findings by Key Opinion Leaders (KOLs) of the Felix System Memphasys Limited announced the first publications of study findings by key opinion leaders (KOLs) of the Felix System - a patented, automated device for quickly and gently separating high quality sperm from a semen sample for use in human IVF procedures. A published article entitled "Spermatozoa isolation with Felix outperforms conventional density gradient centrifugation preparation in selecting cells with low DNA damage" featured in Andrology, the official journal of the American society of Andrology and European Academy of Andrology, on 11th January 2023. The research was conducted by renowned French genetics reproduction and development lab (GReD), supported by the University Clermont Auvergne (UCA), and led by Professor Joel Drevet, an international leader in mammalian andrology ("the KOL"). The KOL studied 29 human semen samples which were analysed fresh and after DGC or Felix System preparation and were monitored by sample volume, sperm count, total motility, progressive motility, sperm DNA fragmentation using the Sperm Chromatin Structure Assay ("SCSA") and sperm DNA oxidation. Results of the study highlighted spermatozoa preparation with Felix System "significantly improved spermatozoa fractions with higher progressive motility, lower sperm DNA fragmentation, and lower sperm DNA oxidation compared with raw semen and DGC-prepared spermatozoa". The article noted that the study data supported spermatozoa preparation by the Felix system "as it allows selection of spermatozoa with the highest progressive motility as well as the lowest nuclear/DNA damage." The article concluded that "These improved sperm parameters, along with the fact that the Felix separation process is very fast and highly standardized, should be of great interest to the assisted reproduction technologies industry." In addition, another article entitled "A comparison between the Felix electrophoretic system of sperm isolation and conventional density gradient centrifugation: a multicentre analysis", has been published in Journal of Assisted Reproduction and Genetics, an official journal of the American Society for Reproductive Medicine. Supported by Memphasys, the research was conducted and collaborated across five KOLs namely: Monash IVF, Australia; Andrology Center, India; The Ronald O. Perelman and Claudia Cohen Center for Reproductive Medicine, USA; GeneraLife IVF, Sweden; Reproductive and Genetic Hospital, People's Republic of China. The KOLs compared the quality of the sperm populations isolated by the Felix System and DGC in terms of processing time, sperm concentration, motility, vitality, and DNA integrity as assessed by 3 methods: SCSA, Halo, and TUNEL. Across all KOLs, 112 comparisons were performed with findings highlighting the Felix system "is a positive technical development capable of isolating suspensions of highly motile spermatozoa in a fraction of the time taken by conventional procedures such as DGC." Four of the five centres reported a significant improvement in DNA integrity relative to DGC (one reported no statistical difference but both methods selected sperm with low DNA damage). The Felix system isolates sperm in a standardised 6-minute preparation time whereas clinical DGC protocols vary between sites but generally took around 40 minutes to complete. Board Change • Nov 16
Less than half of directors are independent Following the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 3 non-independent directors. Independent Non-Executive Director Paul Wright was the last independent director to join the board, commencing their role in 2020. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Ankündigung • Aug 25
Memphasys Limited has completed a Follow-on Equity Offering in the amount of AUD 1.6 million. Memphasys Limited has completed a Follow-on Equity Offering in the amount of AUD 1.6 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 80,000,000
Price\Range: AUD 0.02
Discount Per Security: AUD 0.0012
Transaction Features: Subsequent Direct Listing Board Change • Aug 17
Less than half of directors are independent Following the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 3 non-independent directors. Independent Non-Executive Director Paul Wright was the last independent director to join the board, commencing their role in 2020. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Ankündigung • Jun 29
Memphasys Limited Enrolls the Clinical Study on its Felix Device and Treated the First Couple 2 Memphasys Limited announced that the clinical study on its FelixTM device (FELIX- ICSI) has enrolled and treated the first couple 2. The clinical study is being conducted in collaboration with leading Australian reproductive and fertility services company Monash IVF Group Ltd. (MIVF) and Mobius Medical, the appointed Contract Research Organisation managing the study on behalf of Memphasys. In total, 104 couples will be enrolled across seven MIVF sites. Four of the MIVF sites are now cleared to commence patient recruitment and study enrolment with three more sites to come on stream by 1 August. All MIVF personnel conducting the study at the chosen MIVF sites have been fully trained in the conduct of the study. The study is scheduled to be completed by end of December 2022, subject to recruitment /treatment rates. The clinical study, which has received ethics approval, will assess the safety and performance of the FelixTM device vs Swim-Up and Density Gradient Centrifugation for couples suffering from male infertility factors, to isolate sperm from semen prior to its use for ICSI, a common technique used in assisted reproductive technologies. The clinical study results, together with a comprehensive literature review, will be filed in a formal regulatory submission (conformity assessment application) to the Therapeutic Goods Administration (TGA) in Australia to support the FelixTM device achieving medical device ARTG inclusion to enable commercial sales in Australia. These clinical data will also support FelixTM device registrations in other international jurisdictions. Board Change • May 04
Less than half of directors are independent Following the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 3 non-independent directors. Independent Non-Executive Director Paul Wright was the last independent director to join the board, commencing their role in 2020. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Ankündigung • Dec 20
Memphasys Limited Announces First Felix System Commercial Sale for Clinical Ivf Use Memphasys Limited advised it has reached an important milestone, with the first commercial sales of its FelixTM System - a novel automated device for quickly and gently separating high quality sperm from a semen sample for use in human IVF procedures - for clinical IVF use to the Womens Centre in Coimbatore, India. The Womens Centre has been a participant in the FelixTM System Key Opinion Leader ("KOL") in vitro study, which is being conducted across 13 leading IVF centres in 8 countries. It was established more than 30 years ago and has a chain of fertility centres located in four (4) regional Southern Indian cities. It is a holistic facility providing high quality health care catering to a wide range of womens' health needs including IVF treatments, other fertility and maternal, fetal and neonatal care needs and gynecological services and it also operates a regional andrology reference centre, which has conducted the KOL testing. This first sale consists of a desk top console, which provides the power to operate the system, and a batch of single-use cartridges. The cartridge processes the semen sample to select sperm with the least DNA damage. One cartridge is used for each semen sample processed, providing separated sperm ready for use in IVF procedures after 6 minutes' processing. The clinic has indicated that orders of further cartridges are likely to be ordered after determining future patient caseloads and how the device will be adopted in its clinical practice. The Womens Centre will initially utilise the FelixTM system for IVF cases where the male has demonstrated potential signs of below average sperm quality (low sperm concentration, poor motility, high DNA damage or poor morphology), which according to the Centre represents almost half of male semen samples they deal with. India is one of the four `early markets' for the FelixTM system. It accounts for approximately 10% of the global demand for fresh IVF cycles 1. It classes the FelixTM System as a laboratory device, permitting early access for sales. In 2017, approximately 190,000 IVF cycles were performed in the country. This number is anticipated to rise to 587,570 by 2025. One Felix cartridge is used for each semen sample processed, which is required for each cycle. Ankündigung • Dec 17
Memphasys Ordinary Shares to Be Deleted from Other OTC Memphasys Limited's Ordinary Shares will be deleted from other OTC effective from December 17, 2021 due to Inactive Security. Ankündigung • Jul 03
Memphasys Limited Advises That All Remaining Verification Tasks Associated with the Upgraded Felix Device Have Successfully Passed the Verification Process Memphasys Limited advised that all remaining verification tasks associated with the upgraded Felix Device have successfully passed the verification process. A number of validation tasks remain outstanding; however, they are expected to be completed as previously advised during the quarter ending 30 September 2021. Prior to completion of the validation tasks Memphasys will provide the upgraded Felix Device to its Key Opinion Leader (KOL) network for in-clinic testing. The Company has placed a priority for testing on the KOL locations in its identified early commercial markets (i.e. Japan, India, Canada and New Zealand). Once clinical testing of the upgraded Felix device has been completed successfully, sales discussions with KOL partners and other prospects in early access markets will resume. The Company anticipates initiating commercial sales discussions in early access markets in the latter part of the quarter ending 30 September 2021. Ankündigung • May 04
Memphasys Limited Updates on Assisted Reproductive Biotechnology Products Memphasys Limited provided an update on the progress that is being made on its portfolio of assisted reproductive biotechnology products which are being developed in conjunction with global reproductive biology expert, Professor John Aitken, and his research team at University of Newcastle. A unique opportunity is now available to Memphasys to develop such a potentially high value portfolio of products in the reproductive biotechnology field and as a result, Memphasys is expanding its focus into reproductive biotechnology as well as bioseparations. Memphasys is utilising Professor John Aitken's vast knowledge and experience in this field, his oversight on all of the projects and the highly
credentialled team he has recruited and trained at the Unversity of Newcastle. The product portfolio is focused on reproduction in both humans and animals and ranges from prospective novel medical devices and in vitro diagnostics to new, proprietary media. With initial technical feasibility studies on these projects to establish operational and economic viability completed, Memphasys has determined that the Stallion Fertility Test (at dismount) is to be the first of
the products to be progressed to the next development stage. A prototype diagnostic product, now being developed, is planned to be field tested during the race horse breeding season starting in September 2021 in Australia. The stallion dismount diagnostic will be a rapid and easily applied in vitro test used at the breeding shed to detect the probability of the stallion being able to fertilise a mare based on the level of mitochondrial activity in the spermatozoa. The result would be known almost instantly following mating using a very small dismount semen sample. The test is based on the fact that equine spermatozoa are highly dependent on their mitochondria to generate the energy needed for motility and fertilisation of the egg. Since the spermatozoa of other ungulate species (cattle, pigs and sheep) have a similar pattern of metabolism, Professor Aitken and his research team are confident that this diagnostic system will also permit the rapid assessment of semen quality in other commercially valuable domestic species. Ankündigung • Apr 27
Memphasys Limited Provides Further Update on the Status of the Remediation Process for the Felix Device Memphasys Limited provided a further update on the status of the remediation process for the Felix device following the identification of an engineering issue that constrained its performance. Further assessments by research and development partners using a modified device with the engineering modification have yielded positive results, further validating the science behind the Felix device as well as demonstrating an improvement in the sperm separation process compared with the prior Felix device. As a result, Memphasys can now provide a more detailed, albeit extended, timeline on the path to market for the Felix device. Verification & Validation Timeframe: As previously announced, the majority of verification work was unaffected by this necessary modification to the design. However, some Felix device verification tasks will need to be redone by development partners. Memphasys anticipates this work will begin once sterilised upgraded cartridges are available with verification work to be completed during the quarter ending 30 June 2021. In addition, some validation works previously performed by development partners will need to be redone with the upgraded Felix device. Memphasys anticipates that this work will begin once sterilised upgraded cartridges are available, with this validation work anticipated to be completed during the quarter ending 30 September 2021. 