Announcement • Jun 02
Imagion Biosystems Ind Application for Magsense Phase 2 Clinical Trial Clears Fda Review Imagion Biosystems Ltd. announced that the US Food and Drug Administration (FDA) completed its review of the company’s investigational new drug (IND) application, issuing a “Study May Proceed” letter for Phase 1b/2 clinical trials of the MagSense Imaging Agent in HER2+ breast cancer. MagSense is a first-of-its-class molecular MRI (mMRI) imaging agent that uses non-radioactive, bio-safe nanoparticles to help clinicians detect cancer earlier and with greater precision. Phase 1b/2 will be a combined trial designed to confirm the safety profile (Phase 1b) and evaluate efficacy in detecting nodal metastases (Phase 2) in patients with HER2+ breast cancer. Dr. Mohammad Eghtedari, section chief of Women's Imaging at City of Hope Cancer Center in Los Angeles, will serve as the trial’s principal investigator (PI). Eghtedari previously participated as an independent reviewer of MagSense in the company’s Phase I trial. The company expects the trial to yield insights into the potential impact on cost of care, patient outcomes, and clinical value. Paired with quantitative imaging techniques, the trial may produce critical training data for AI diagnostic tools. Conventional imaging can identify regions of interest using anatomical or morphological features, but without molecular specificity, cannot reliably differentiate benign from malignant tumors. MagSense uses targeted nanoparticles to increase imaging specificity, making it easier for clinicians to make diagnoses with certainty. The platform technology’s applications extend beyond breast cancer—Imagion has conducted pre-clinical studies of two additional imaging agents that target prostate and ovarian cancers, which will be prepared for IND-enabling studies. New Risk • Jun 02
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 17% 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$4.0m free cash flow). Share price has been highly volatile over the past 3 months (17% average weekly change). Negative equity (-AU$2.2m). Shareholders have been substantially diluted in the past year (144% increase in shares outstanding). Revenue is less than US$1m (AU$73k revenue, or US$52k). Market cap is less than US$10m (AU$9.32m market cap, or US$6.68m). New Risk • Apr 23
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 14% 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 Less than 1 year of cash runway based on free cash flow trend (-AU$4.0m free cash flow). Negative equity (-AU$2.2m). Shareholders have been substantially diluted in the past year (144% increase in shares outstanding). Revenue is less than US$1m (AU$73k revenue, or US$52k). Market cap is less than US$10m (AU$8.83m market cap, or US$6.30m). Minor Risk Share price has been volatile over the past 3 months (14% average weekly change). Announcement • Apr 07
Imagion Biosystems Limited, Annual General Meeting, May 26, 2026 Imagion Biosystems Limited, Annual General Meeting, May 26, 2026. Reported Earnings • Mar 02
Full year 2025 earnings released: AU$0.016 loss per share (vs AU$0.046 loss in FY 2024) Full year 2025 results: AU$0.016 loss per share. Net loss: AU$4.31m (loss widened 109% from FY 2024). Announcement • Feb 04
Imagion Biosystems Ltd. Lodges IND with FDA for Phase 2 Trial of MagSense HER2 Targeting Imaging Agent Imagion Biosystems Ltd. announced that the company has progressed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for its MagSense®? targeted imaging agent. Following FDA approval, the company expects to start a Phase 2 clinical trial with the imaging agent for the detection of nodal metastases in HER2+ breast cancer patients. MagSense®? is a first-of-its-class molecular MRI (mMRI) platform technology that uses iron oxide nanoparticles with custom moieties (e.g., antibodies) to target specific disease biomarkers. Unlike general purpose contrast agents, MagSense®? particles are only detected when and where cancer is present. Using MRI, the presence of iron oxide produces a significant, identifiable change in image contrast, empowering clinicians with better information for diagnosis and treatment planning. Based on historical FDA review timelines, the company anticipates enrollment for the Phase 2 trial could begin as early as first quarter 2026. The company has selected and engaged all required strategic trial partners to manage the study and has begun the process of clinical study site engagement and progressing study logistics in compliance with Good Clinical Practices. Announcement • Sep 01
Imagion Biosystems Limited Appoints Nina Webster as Non- Executive Director, Effective 1 September 2025 Imagion Biosystems Limited announced the appointment of Dr. Nina Webster as a Non-Executive Director to the Board, effective 1 September 2025. Dr. Webster brings to the Board a wealth of experience in the Australian ASX listed pharmaceutical industry, holding leadership roles over a thirty-year period. She currently serves as Managing Director and Chief Executive Officer of Dimerix Ltd. Formerly the Commercial Director for Acrux Limited and Director of Commercialisation and Intellectual Property for Immuron Limited, Nina brings to IBX vast experience in investor relations, strategic planning, and scientific and operational execution. Dr. Webster holds a Ph.D in Pharmaceutics, a Bachelor's degree in Pharmacology, a Master's degree in Intellectual Property Law and an Executive MBA and currently also serves as Non-Executive Chairperson for SYNthesis BioVentures and as Non-Executive Director for Linear Clinical Research Limited. The addition of Dr. Webster to the IBX Board of Directors will further strengthen the Board's capabilities as the Company continues to execute on its strategic objectives to develop and gain regulatory approval for its pipeline of MagSense® molecular imaging technologies. Reported Earnings • Aug 29
First half 2025 earnings released: AU$0.008 loss per share (vs AU$0.047 loss in 1H 2024) First half 2025 results: AU$0.008 loss per share. Revenue: AU$25.7k (down 98% from 1H 2024). Net loss: AU$1.66m (loss widened 8.8% from 1H 2024). New Risk • Aug 28
New major risk - Revenue size The company makes less than US$1m in revenue. Total revenue: AU$1.1m (US$687k) This is considered a major risk. Companies with a small amount of revenue 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 (22% average weekly change). Negative equity (-AU$3.9m). Shareholders have been substantially diluted in the past year (over 5x increase in shares outstanding). Revenue is less than US$1m (AU$1.1m revenue, or US$687k). Market cap is less than US$10m (AU$3.94m market cap, or US$2.57m). Announcement • Aug 04
Imagion Biosystems Limited has filed a Follow-on Equity Offering in the amount of AUD 3.5 million. Imagion Biosystems Limited has filed a Follow-on Equity Offering in the amount of AUD 3.5 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 223,333,333
Price\Range: AUD 0.015
Discount Per Security: AUD 0.0009
Security Features: Attached Options
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 10,000,000
Price\Range: AUD 0.015
Discount Per Security: AUD 0.0009
Security Features: Attached Options
Transaction Features: Subsequent Direct Listing New Risk • Jul 10
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 22% 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 Share price has been highly volatile over the past 3 months (22% average weekly change). Negative equity (-AU$2.3m). Earnings have declined by 12% per year over the past 5 years. Shareholders have been substantially diluted in the past year (over 5x increase in shares outstanding). Market cap is less than US$10m (AU$3.83m market cap, or US$2.51m). Minor Risk Revenue is less than US$5m (AU$2.7m revenue, or US$1.7m). Announcement • Apr 01
Imagion Biosystems Limited, Annual General Meeting, May 30, 2025 Imagion Biosystems Limited, Annual General Meeting, May 30, 2025. Reported Earnings • Mar 01
Full year 2024 earnings released: AU$0.046 loss per share (vs AU$0.41 loss in FY 2023) Full year 2024 results: AU$0.046 loss per share (improved from AU$0.41 loss in FY 2023). Revenue: AU$2.67m (down 46% from FY 2023). Net loss: AU$2.07m (loss narrowed 83% from FY 2023). New Risk • Dec 17
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Over 5x increase in shares outstanding. 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 (31% average weekly change). Negative equity (-AU$5.3m). Earnings have declined by 22% per year over the past 5 years. Shareholders have been substantially diluted in the past year (over 5x increase in shares outstanding). Market cap is less than US$10m (AU$4.43m market cap, or US$2.82m). Minor Risk Revenue is less than US$5m (AU$5.9m revenue, or US$3.8m). Announcement • Dec 13
Imagion Biosystems Limited has completed a Follow-on Equity Offering in the amount of AUD 0.125 million. Imagion Biosystems Limited has completed a Follow-on Equity Offering in the amount of AUD 0.125 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 6,250,000
Price\Range: AUD 0.02
Discount Per Security: AUD 0.0012
Security Features: Attached Options
Transaction Features: Subsequent Direct Listing Announcement • Nov 08
Imagion Biosystems Limited has filed a Follow-on Equity Offering in the amount of AUD 0.125 million. Imagion Biosystems Limited has filed a Follow-on Equity Offering in the amount of AUD 0.125 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 6,250,000
Price\Range: AUD 0.02
Discount Per Security: AUD 0.0012
Security Features: Attached Options
Transaction Features: Subsequent Direct Listing New Risk • Aug 01
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 7.2% 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 Less than 1 year of cash runway based on free cash flow trend (-AU$8.5m free cash flow). Negative equity (-AU$3.8m). Earnings have declined by 21% per year over the past 5 years. Market cap is less than US$10m (AU$1.54m market cap, or US$1.01m). Minor Risks Shareholders have been diluted in the past year (7.2% increase in shares outstanding). Revenue is less than US$5m (AU$5.0m revenue, or US$3.2m). Announcement • Aug 01
Imagion Biosystems Limited Announces Board Changes Imagion Biosystems Limited announced that Ms Melanie Leydin will join the Board as a Non-Executive Director with the appointment effective from 31 July 2024. Ms Leydin has over 25 years' experience in the accounting profession and over 15 years as a company secretary with extensive experience in relation to public company responsibilities, including ASX and ASIC compliance, control and implementation of corporate governance, statutory financial reporting, re-organization of Companies and shareholder relations. IBX announced that, effective immediately before the conclusion of the General Meeting scheduled on 22 August 2024, Michael Harsh, David Ludvigson and Mark Van Astan, will cease to hold office. (That is, all of the directors who were in office at the time the directors' report (as included in the Company's annual financial report for the financial year ended 31 December 2023) was approved, other than Robert Proulx who acts as Executive Chairman and Managing Director, will cease to hold office). Board Change • Jun 14
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. 3 experienced directors. 1 highly experienced director. No independent directors (4 non-independent directors). Non Executive Director David Ludvigson was the last director to join the board, commencing their role in 2017. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of independent directors. Insufficient board refreshment. Announcement • May 06
Imagion Biosystems Limited, Annual General Meeting, May 31, 2024 Imagion Biosystems Limited, Annual General Meeting, May 31, 2024, at 10:01 E. Australia Standard Time. Location: K&L Gates Melbourne, Level 25, 525 Collins Street Melbourne Victoria Australia Agenda: To receive and consider the Financial Report of the Company and its controlled entities and the related Directors' and Auditor's Reports in respect of the financial year ended 31 December 2023; to consider adoption of the Remuneration Report; to approve re-Election of Director; and to consider other matters. Reported Earnings • Mar 01
Full year 2023 earnings released: AU$0.004 loss per share (vs AU$0.35 loss in FY 2022) Full year 2023 results: AU$0.004 loss per share. Revenue: AU$5.18m (up 69% from FY 2022). Net loss: AU$13.1m (loss widened 33% from FY 2022). Announcement • Nov 15
Imagion Biosystems Limited Approves Election of Isaac Bright as Director Imagion Biosystems Limited announced that at its Extraordinary General Meeting held on 13 November 2023, the shareholders approved Election of Director - Dr. Isaac Bright. New Risk • Oct 13
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: AU$15.7m (US$9.89m) 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$9.6m free cash flow). Share price has been highly volatile over the past 3 months (17% average weekly change). Negative equity (-AU$1.6m). Earnings have declined by 13% per year over the past 5 years. Market cap is less than US$10m (AU$15.7m market cap, or US$9.89m). Minor Risks Shareholders have been diluted in the past year (16% increase in shares outstanding). Revenue is less than US$5m (AU$3.5m revenue, or US$2.2m). Reported Earnings • Sep 03
First half 2023 earnings released: AU$0.007 loss per share (vs AU$0.005 loss in 1H 2022) First half 2023 results: AU$0.007 loss per share (further deteriorated from AU$0.005 loss in 1H 2022). Revenue: AU$690.0k (up 160% from 1H 2022). Net loss: AU$7.68m (loss widened 33% from 1H 2022). Over the last 3 years on average, earnings per share has fallen by 13% per year but the company’s share price has fallen by 44% per year, which means it is performing significantly worse than earnings. New Risk • Aug 31
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$9.6m 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$9.6m free cash flow). Share price has been highly volatile over the past 3 months (21% average weekly change). Negative equity (-AU$1.6m). Earnings have declined by 13% per year over the past 5 years. Minor Risks Shareholders have been diluted in the past year (16% increase in shares outstanding). Revenue is less than US$5m (AU$3.5m revenue, or US$2.3m). Market cap is less than US$100m (AU$19.6m market cap, or US$12.7m). New Risk • Aug 30
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended December 2022. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (21% average weekly change). Earnings have declined by 3.8% per year over the past 5 years. 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 (16% increase in shares outstanding). Revenue is less than US$5m (AU$3.1m revenue, or US$2.0m). Market cap is less than US$100m (AU$20.9m market cap, or US$13.5m). New Risk • Jun 23
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 Risk Earnings have declined by 3.8% per year over the past 5 years. Minor Risks Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (4.1% increase in shares outstanding). Revenue is less than US$5m (AU$3.1m revenue, or US$2.1m). Market cap is less than US$100m (AU$15.2m market cap, or US$10.2m). Announcement • Jun 19
Imagion Biosystems Limited Announces CEO Changes Imagion Biosystems Limited announced it has appointed Isaac Bright, MD as CEO, effective 20 June 2023. Dr. Bright is a results-focused business leader and brings to Imagion over 20 years of experience as a health industry executive and venture capitalist in medical technology, biopharmaceuticals, and oncology-based molecular diagnostics. Dr. Bright most recently served as Co-Founder, CEO, and Chairman of RubrYc Therapeutics Inc. before its trade sale to iBio Inc. in September 2022. Prior to launching RubrYc, Dr. Bright was Chief Business Officer for molecular diagnostics innovator HealthTell Inc., driving its trade sale to iCarbonX, concomitant with RubrYc’s launch in 2018. Prior to that, Dr. Bright served as VP, Corporate Development for Synthetic Biologics Inc. and consulting Chief Business Officer for synthetic biology innovator musebio Inc. (currently Incripta Inc.) as it secured its $23 million Series B Preferred financing. Dr. Bright was the first American Partner investing with Merieux Developpement (currently, Merieux Equity Partners) from 2012 through 2016, during which he helped the firm raise €150 million Merieux Participations 2 fund. With Merieux, Dr. Bright led investments and Board representation for Imaginab Inc., Kalila Medical Inc. until its acquisition by Abbott, and Twist Bioscience before its IPO. Dr. Bright’s startup experience began as he built and led QuantaLife Inc.’s Corporate Development and Molecular Diagnostics functions from 2009-2011, leading to QuantaLife’s acquisition by Bio-Rad Laboratories Inc. Previously, Dr. Bright served as Sr. Associate, Corporate Development and Director, Business Development - Neuromodulation for global medtech leader Medtronic. Dr. Bright earned his bachelor’s degree in biochemistry from Pepperdine University, his medical degree from the Stanford University School of Medicine and was a Howard E. Mitchell Fellow earning his MBA from the Wharton School at the University of Pennsylvania. The hiring of Dr. Bright follows from the recent announcement on 28 April 2023 regarding the plan for Bob Proulx to retire from the role of CEO, remaining as Chairman of the Board. New Risk • Jun 14
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: AU$14.0m (US$9.48m) 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 Earnings have declined by 3.8% per year over the past 5 years. Market cap is less than US$10m (AU$14.0m market cap, or US$9.48m). Minor Risks Shareholders have been diluted in the past year (4.1% increase in shares outstanding). Revenue is less than US$5m (AU$3.1m revenue, or US$2.1m). Announcement • Dec 08
Imagion Biosystems Limited Reports Positive Clinical Data At Breast Cancer Symposium Imagion Biosystems Limited presented interim data from the Company's on-going Phase I study for its MagSense HER2 breast cancer imaging agent at the 2022 San Antonio Breast Cancer Symposium, a world leading forum for scientists and clinicians focused on breast cancer research and patient care. Previously the Company has reported that the MagSense HER2 imaging agent has been well tolerated and that there have been no safety issues related to the agent identified. Here the Company reports for the first time the initial findings of the exploratory endpoints related to cancer detection. Analysis of the first cohort of six patients suggests that the molecular signature of the MagSense imaging agent, when used with conventional MRI could help discriminate potentially cancerous nodes from normal nodes. The work was presented by Dr. Yalia Jayalakshmi, Chief Development Officer at Imagion Biosystems, and co-authored by study principal investigators. Together, the authors conclude that when combined with standard morphological assessments, the imaging agent "has the potential to improve radiological evaluation thereby improving the standard of care clinical assessments." The Company notes that enrolment for the second cohort is ongoing with results consistent with those reported at the meeting and that further studies will beneeded to broaden the study population to fully characterize the diagnostic performance of the imaging agent. Several important findings have emerged from the results to date: · changes in MR contrast created by the specific binding of the MagSense imaging agent to tumour cells in the nodes aids in resolving nodal status; the imaging agent is detectable by magnetic relaxometry, however more subject samples are needed due to the limited amount of accessible dissected nodal tissue to-date; and there have been no safety, toxicity or adverse events reported related to the imaging agent. Breast cancer is one of the most commonly diagnosed cancers among women and is the second leading cause of cancer deaths among women overall. Of the four breast cancer subtypes, HER2 represents 10-20 percent and has significant prognostic and predictive implications because the HER2 subtype is considered an aggressive phenotype with a high rate of recurrence and metastasis. The HER2 status is frequently maintained during progression to invasive disease, nodal metastasis, and distant metastasis. Nodal status often determines the course of treatment including systemic therapy, the extent of surgery, reconstruction options, and the need for radiation therapy after mastectomy. Currently, nodal assessment is based on palpation or conventional imaging techniques, predominantly ultrasound. These methods try to identify nodes that appear to be abnormal by size or shape but are not able to confirm if cancer is present. Therefore, the current standard of care still relies on invasive biopsies and follow up by a pathological confirmation to inform clinical decision making. Imagion's noninvasive and molecularly specific approach to cancer detection has the potential to improve the overall diagnostic accuracy of axillary nodal imaging and reduce the need for invasive biopsies. Board Change • Nov 16
No independent directors Following the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 6 non-independent directors. Non-Executive Director Dianne Angus was the last director to join the board, commencing their role in 2020. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model. Reported Earnings • Aug 26
First half 2022 earnings released: AU$0.005 loss per share (vs AU$0.001 loss in 1H 2021) First half 2022 results: AU$0.005 loss per share (down from AU$0.001 loss in 1H 2021). Net loss: AU$5.76m (loss widened 297% from 1H 2021). Over the last 3 years on average, earnings per share has increased by 27% per year but the company’s share price has fallen by 1% per year, which means it is significantly lagging earnings. Board Change • Apr 27
No independent directors There are 5 new directors who have joined the board in the last 3 years. Of these new board members, none were independent directors. The company's board is composed of: 5 new directors. 6 experienced directors. No highly experienced directors. No independent directors (6 non-independent directors). Non Executive Director Mark Van Asten is the most experienced director on the board, commencing their role in 2016. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of independent directors. Lack of board continuity. Lack of experienced directors. Announcement • Apr 14
Imagion Biosystems Limited, Annual General Meeting, May 25, 2022 Imagion Biosystems Limited, Annual General Meeting, May 25, 2022. Reported Earnings • Feb 25
Full year 2021 earnings: Revenues and EPS in line with analyst expectations Full year 2021 results: AU$0.006 loss per share (up from AU$0.007 loss in FY 2020). Revenue: AU$2.86m (up 5.9% from FY 2020). Net loss: AU$6.02m (loss widened 12% from FY 2020). Revenue was in line with analyst estimates. Over the last 3 years on average, earnings per share has increased by 67% per year but the company’s share price has only increased by 32% per year, which means it is significantly lagging earnings growth. Reported Earnings • Aug 22
First half 2021 earnings released: AU$0.001 loss per share (vs AU$0.003 loss in 1H 2020) The company reported a solid first half result with reduced losses, improved revenues and improved control over expenses. First half 2021 results: Revenue: AU$2.78m (up 20% from 1H 2020). Net loss: AU$1.45m (loss narrowed 17% from 1H 2020). Over the last 3 years on average, earnings per share has increased by 66% per year but the company’s share price has only increased by 4% per year, which means it is significantly lagging earnings growth. Announcement • May 28
Imagion Biosystems Limited Announces First Patient Enrolled in the MagSense® HER2 Breast Cancer Phase I First-In-Human Study Imagion Biosystems Limited announced that the first patient has been enrolled in the MagSense® HER2 breast cancer Phase I first-in-human study. The study, which is expected to enroll approximately 15 patients, is the first clinical investigation of Imagion Biosystems' MagSense® nanoparticle technology. This study investigates the use of a MagSense® imaging agent as a means of aiding in the staging of HER2 positive breast cancer by detecting if the patient's tumor has spread to the lymph nodes. Current standard of care requires biopsy or surgical removal of lymph nodes to confirm metastases. With approximately half of HER2 breast cancer patients having no nodal disease, the MagSense® HER2 test achieved Breakthrough Device designation from the US FDA based on its potential to provide a non-invasive way to eliminate unnecessary surgical biopsy procedures and their resultant morbidities. Each patient in the study receives an injection of the MagSense® nanoparticle imaging agent and undergoes imaging by MRI. Additionally, a sample of the lymph node is also assessed using Imagion's proprietary MagSense® magnetic relaxometry technology. The primary endpoint of the study is to determine the safety and tolerability of the MagSense® imaging agent, but the study will also explore the effectiveness of the nanoparticles for in vivo detection which will inform further development and commercial considerations. Announcement • Mar 17
Imagion Biosystems Limited Receives CSIRO Grant for Prostate Cancer Project Imagion Biosystems Limited announced that it is the recipient of an Innovations Connections grant under the Entrepreneurs' Programme of the Australian Government Department of Industry, Science, Energy and Resources. Innovations Connections is a Federal Government funding program delivered by the CSIRO aimed to facilitate connecting industry with researchers to help fast-track R&D projects. The $50,000 grant will be used to help support a preclinical research project between Imagion and researchers at Monash University's Biomedicine Discovery Institute with the aim of achieving an early proof of concept validation of a MagSense prostate cancer imaging agent. Prostate cancer is the second most common cancer in men with the prostate cancer diagnostics market valued at USD 6.2 billion in 2019. While the widespread use of PSA testing over the past decades has resulted in a significant increase in the diagnosis and treatment of prostate cancer, PSA screening has come under scrutiny because many men do not benefit from intervention because the disease is either indolent or disseminated at the time of diagnosis. There is a clear unmet medical need for a non-invasive bio-safe diagnostic technology that can identify high at-risk localized prostate cancer. Reported Earnings • Feb 26
Full year 2020 earnings released: AU$0.007 loss per share (vs AU$0.01 loss in FY 2019) The company reported a soft full year result with increased losses and weaker control over costs, although revenues improved. Full year 2020 results: Revenue: AU$2.70m (up 8.3% from FY 2019). Net loss: AU$5.36m (loss widened 56% from FY 2019). Over the last 3 years on average, earnings per share has increased by 63% per year but the company’s share price has only increased by 40% per year, which means it is significantly lagging earnings growth. Is New 90 Day High Low • Feb 17
New 90-day high: AU$0.21 The company is up 72% from its price of AU$0.13 on 18 November 2020. The Australian market is up 8.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Medical Equipment industry, which is down 8.0% over the same period. Is New 90 Day High Low • Jan 25
New 90-day high: AU$0.21 The company is up 192% from its price of AU$0.072 on 27 October 2020. The Australian market is up 12% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Medical Equipment industry, which is down 6.0% over the same period. Announcement • Dec 17
Imagion Biosystems Limited Provides First-In-Human Study Update - Study Open for Enrolment Imagion Biosystems Limited announced that Monash Health has been established as the first clinical site and is ready to commence enrolment of patients for the MagSenseTM HER2 breast cancer Phase I first-in-human study. Dr Jane Fox, the current Director of Breast Services at Monash Health, which encompasses breast surgery and the Monash BreastScreen program, has been named as the Principal Investigator of the MagSenseTM study. Dr Fox is also a senior lecturer in the Monash University Department of Surgery and a senior leader of the multi-disciplinary team at the Monash Cancer Centre which includes medical imaging, medical oncology and radiation oncology. Announcement • Dec 10
Imagion Biosystems Limited Announces Change of Company Secretary Imagion Biosystems Limited announces that Ms Jovanka Naumoska has resigned from her position as Company Secretary of Imagion, effective 8 December 2020. Ms Naumoska will remain on the Board as a Non-Executive Director. The Company has appointed Mr. Geoff Hollis as Company Secretary, effective today. Mr. Hollis was recently appointed as the Company's Chief Financial Officer. Announcement • Nov 24
Imagion Biosystems Limited announced that it expects to receive AUD 6 million in funding Imagion Biosystems Limited (ASX:IBX) announced a private placement of 70,588,236 shares at a price of AUD 0.085 per shares for gross proceeds of AUD 6,000,000 on November 23, 2020. The transaction included participation from four institutional investors. The transaction was oversubscribed. The transaction is expected to close November 23, 2020. Announcement • Oct 19
Imagion Biosystems Limited Appoints Geoff Hollis as CFO Imagion Biosystems Limited has appointed Geoff Hollis as chief financial officer. Geoff, based in Melbourne, takes up his position as the company CFO on 1 December 2020. Geoff replaces Brian Conn, who served as the company's part-time CFO since 2017 and who left the company in August to take up a full-time CFO position with another of his clients. Announcement • Oct 07
Imagion Biosystems Announces HREC Approval for Phase I Study Imagion Biosystems reported that it has received approval from the Human Research Ethics Committee for the MagSenseTM HER2 Phase I study for metastatic breast cancer. With the study now approved the company can proceed with finalising contracts with individual study sites. Additionally, the company reports that manufacturing of the MagSenseTM HER2 nanoparticle formulation for the study remains on track, having successfully completed bulk batch production. The company expects to complete the final step of Good Manufacturing Practice compliant packaging of the material on time to support the start of the study. 