Price Target Changed • Jul 15
Price target decreased by 14% to AU$0.25 Down from AU$0.29, the current price target is provided by 1 analyst. New target price is 181% above last closing price of AU$0.089. Stock is up 25% over the past year. The company posted a net loss per share of US$0.011 last year. Breakeven Date Change • Jun 30
Forecast breakeven date pushed back to 2028 The analyst covering Lumos Diagnostics Holdings previously expected the company to break even in 2026. New forecast suggests losses will reduce by 76% per year to 2027. The company is expected to make a profit of US$4.68m in 2028. Average annual earnings growth of 76% is required to achieve expected profit on schedule. Announcement • Apr 15
Lumos Diagnostics Holdings Limited to Report Q3, 2026 Results on Apr 20, 2026 Lumos Diagnostics Holdings Limited announced that they will report Q3, 2026 results on Apr 20, 2026 New Risk • Apr 10
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: AU$140.5m (US$99.3m) This is considered a minor 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: Minor Risks Share price has been volatile over the past 3 months (15% average weekly change). Market cap is less than US$100m (AU$140.5m market cap, or US$99.3m). Reported Earnings • Mar 04
First half 2026 earnings released: US$0.006 loss per share (vs US$0.005 loss in 1H 2025) First half 2026 results: US$0.006 loss per share (further deteriorated from US$0.005 loss in 1H 2025). Revenue: US$6.12m (down 2.9% from 1H 2025). Net loss: US$4.88m (loss widened 74% from 1H 2025). Revenue is forecast to grow 40% p.a. on average during the next 3 years, compared to a 12% growth forecast for the Medical Equipment industry in Australia. Over the last 3 years on average, earnings per share has increased by 107% per year but the company’s share price has only increased by 92% per year, which means it is significantly lagging earnings growth. Breakeven Date Change • Feb 14
Forecast to breakeven in 2028 The analyst covering Lumos Diagnostics Holdings expects the company to break even for the first time. New forecast suggests losses will reduce by 63% per year to 2027. The company is expected to make a profit of US$3.80m in 2028. Average annual earnings growth of 103% is required to achieve expected profit on schedule. Announcement • Sep 22
Lumos Diagnostics Holdings Limited, Annual General Meeting, Oct 24, 2025 Lumos Diagnostics Holdings Limited, Annual General Meeting, Oct 24, 2025. Location: zoom webinar, Australia Board Change • Aug 29
Less than half of directors are independent Following the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 3 non-independent directors. Independent Director Catherine Robson 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. Reported Earnings • Aug 29
Full year 2025 earnings released: US$0.011 loss per share (vs US$0.019 loss in FY 2024) Full year 2025 results: US$0.011 loss per share (improved from US$0.019 loss in FY 2024). Revenue: US$12.4m (up 11% from FY 2024). Net loss: US$7.18m (loss narrowed 16% from FY 2024). Revenue is forecast to grow 34% p.a. on average during the next 2 years, compared to a 11% growth forecast for the Medical Equipment industry in Australia. Over the last 3 years on average, earnings per share has increased by 111% per year but the company’s share price has only increased by 31% per year, which means it is significantly lagging earnings growth. Announcement • Aug 26
Lumos Diagnostics Holdings Limited to Report Fiscal Year 2025 Results on Aug 28, 2025 Lumos Diagnostics Holdings Limited announced that they will report fiscal year 2025 results on Aug 28, 2025 Buy Or Sell Opportunity • Aug 06
Now 26% overvalued after recent price rise Over the last 90 days, the stock has risen 250% to AU$0.091. The fair value is estimated to be AU$0.072, however this is not to be taken as a sell recommendation but rather should be used as a guide only. Revenue has declined by 4.8% over the last 3 years. Earnings per share has grown by 82%. Revenue is forecast to grow by 36% in 2 years. Earnings are forecast to grow by 51% in the next 2 years. Announcement • Jul 17
Lumos Diagnostics Holdings Limited announced that it expects to receive AUD 5 million in funding Lumos Diagnostics Holdings Limited announced that it has signed a binding term sheet to issue secured loan facility of AUD 5 million on July 17, 2025. The transaction included participation from new lender Ryder Capital Management Pty Ltd and Tenmile Ventures Pty Ltd. The company will receive each drawdown of minimum amount of AUD 0.5 million and will not exceed AUD 1.5 million. The loan bears a interest of 15% per annum for the first 12 months and if the company exercised its option to extend the loan, then the interest rate is 20% per annum for months 13–18 and 25% per annum for months 19–24. New Risk • Jul 16
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 43% 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 (43% average weekly change). Shareholders have been substantially diluted in the past year (56% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$2.6m net loss in 2 years). Market cap is less than US$100m (AU$53.1m market cap, or US$34.7m). New Risk • Mar 10
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: AU$15.7m (US$9.94m) 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 Shareholders have been substantially diluted in the past year (56% increase in shares outstanding). Market cap is less than US$10m (AU$15.7m market cap, or US$9.94m). Minor Risk Share price has been volatile over the past 3 months (12% average weekly change). New Risk • Nov 28
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 7.3% per year over the past 5 years. Shareholders have been substantially diluted in the past year (55% increase in shares outstanding). Minor Risks Share price has been volatile over the past 3 months (12% average weekly change). Market cap is less than US$100m (AU$22.4m market cap, or US$14.5m). New Risk • Oct 20
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 68% 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 7.3% per year over the past 5 years. Shareholders have been substantially diluted in the past year (68% increase in shares outstanding). Minor Risk Market cap is less than US$100m (AU$33.6m market cap, or US$22.5m). Announcement • Oct 14
Lumos Diagnostics Holdings Limited, Annual General Meeting, Nov 14, 2024 Lumos Diagnostics Holdings Limited, Annual General Meeting, Nov 14, 2024. Location: held via zoom webinar, Australia Announcement • Sep 03
Lumos Diagnostics Holdings Limited has filed a Follow-on Equity Offering in the amount of AUD 10 million. Lumos Diagnostics Holdings Limited has filed a Follow-on Equity Offering in the amount of AUD 10 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 263,157,895
Price\Range: AUD 0.038
Transaction Features: Rights Offering Reported Earnings • Aug 29
Full year 2024 earnings released: US$0.018 loss per share (vs US$0.038 loss in FY 2023) Full year 2024 results: US$0.018 loss per share (improved from US$0.038 loss in FY 2023). Revenue: US$11.1m (up 5.7% from FY 2023). Net loss: US$8.59m (loss narrowed 4.2% from FY 2023). Announcement • Jul 29
Lumos Diagnostics Holdings Limited to Report Fiscal Year 2024 Results on Jul 31, 2024 Lumos Diagnostics Holdings Limited announced that they will report fiscal year 2024 results on Jul 31, 2024 Announcement • Feb 23
Lumos Diagnostics Holdings Limited to Report First Half, 2024 Results on Feb 28, 2024 Lumos Diagnostics Holdings Limited announced that they will report first half, 2024 results on Feb 28, 2024 Announcement • Nov 01
Lumos Diagnostics Holdings Limited has completed a Follow-on Equity Offering in the amount of AUD 2.65 million. Lumos Diagnostics Holdings Limited has completed a Follow-on Equity Offering in the amount of AUD 2.65 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 37,857,142
Price\Range: AUD 0.07
Discount Per Security: AUD 0.0042
Transaction Features: Subsequent Direct Listing Announcement • Oct 02
Lumos Diagnostics Holdings Limited, Annual General Meeting, Nov 02, 2023 Lumos Diagnostics Holdings Limited, Annual General Meeting, Nov 02, 2023, at 09:00 AUS Eastern Standard Time. Agenda: To consider the Adoption of Remuneration Report; to consider Re-election of Lawrence Mehren as a Director of the Company; to consider Re-election of Catherine Robson as a Director of the Company; to consider Ratification of Prior Issue of 67,857,143 Ordinary Fully Paid Shares; to consider Ratification of Prior Issue of 4,050,000 Unquoted Options; to consider Adoption of the Company's Amended Long Term Incentive Plan; and to consider Approval of 10% Placement Facility. Reported Earnings • Sep 01
Full year 2023 earnings released: US$0.038 loss per share (vs US$0.30 loss in FY 2022) Full year 2023 results: US$0.038 loss per share (improved from US$0.30 loss in FY 2022). Revenue: US$10.5m (down 9.4% from FY 2022). Net loss: US$8.97m (loss narrowed 80% from FY 2022). Announcement • Aug 30
Lumos Diagnostics Holdings Limited to Report Fiscal Year 2023 Results on Aug 30, 2023 Lumos Diagnostics Holdings Limited announced that they will report fiscal year 2023 results on Aug 30, 2023 New Risk • Aug 29
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 (-US$13m free cash flow). Share price has been highly volatile over the past 3 months (74% average daily change). Earnings have declined by 52% per year over the past 5 years. Shareholders have been substantially diluted in the past year (111% increase in shares outstanding). Minor Risks Latest financial reports are more than 6 months old (reported December 2022 fiscal period end). Market cap is less than US$100m (AU$51.0m market cap, or US$32.9m). Board Change • Jul 20
High number of new and inexperienced directors There are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. 1 experienced director. No highly experienced directors. Executive Chairman Sam Lanyon is the most experienced director on the board, commencing their role in 2019. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Announcement • Jul 13
Lumos Diagnostics Holdings Limited Appoints Doug Ward to Board as Managing Director Lumos Diagnostics announced its Chief Executive Officer, Doug Ward, has been appointed to Lumos Diagnostics' Board of Directors as Managing Director. Doug Ward was appointed and commenced as CEO of Lumos in June 2022. Doug has over 30 years experience as an executive in the diagnotics and healthcare industries. He joined from his previous role at the leading US women's healthcare company, Hologic. Prior to this, Doug was CEO of PDGX, a genomics in vitro diagnostics company that was acquired by LabCorp in 2022 for USD 575 million. Since his appointment, Doug has played a key role in the restructuring and refocusing of Lumos, as well as managing FebriDx through the recent FDA clearance following its rejection last year. New Risk • Jul 08
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 58% 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 Less than 1 year of cash runway based on free cash flow trend (-US$13m free cash flow). Share price has been highly volatile over the past 3 months (75% average daily change). Earnings have declined by 52% per year over the past 5 years. Shareholders have been substantially diluted in the past year (58% increase in shares outstanding). Minor Risk Market cap is less than US$100m (AU$28.5m market cap, or US$19.1m). Announcement • Nov 23
Lumos Diagnostics Holdings Limited announced that it expects to receive AUD 8 million in funding from SBC Global Investors, The Lind Partners, LLC Lumos Diagnostics Holdings Limited announced that it has entered into agreement for a private placement of convertible note for proceeds of AUD 8,000,000 on November 21, 2022. The transaction will include participation from The Lind Partners, LLC and SBC Global Investment Fund, a fund managed by SBC Global Investors. The company will receive funding in two tranches where each tranche consists of AUD 4,000,000 each. The notes carry a zero interest rate and have a term of 24 Months. The notes are convertible into shares Conversion Price will be the lesser of 100% premium to the average of 5 daily VWAPs preceding closing and 90% of the average of the 5 lowest daily VWAPs during the 20 trading days preceding the date of share issuance, provided that the Fixed Price or Variable Price cannot be less than the floor price of AUD 0.025. The transaction is subject to shareholders at General Meeting to be conducted on December 22, 2022. Price Target Changed • Nov 16
Price target decreased to AU$0.077 Down from AU$0.30, the current price target is an average from 2 analysts. New target price is 55% above last closing price of AU$0.05. Stock is down 94% over the past year. The company is forecast to post a net loss per share of US$0.11 next year compared to a net loss per share of US$0.30 last year. Announcement • Oct 19
Lumos Diagnostics Announces Publication of Data from DISRUPT Clinical Trial of FebriDx in JAMA Open Network Lumos Diagnostics announced that results of its DISRUPT clinical trial of FebriDx® as an aid to differentiate bacterial from viral acute respiratory infections (ARI's) has been published in the peer-reviewed journal JAMA Open Network. The authors concluded that the rapid diagnostic test demonstrated performance that may inform clinicians when assessing for bacterial or viral etiology of ARI symptoms. The DISRUPT trial was a prospective, blinded, multicentre, observational study of FebriDx's performance in identifying bacterial versus viral acute respiratory infections. Participants were enrolled between October 2019 and April 2021 at 20 outpatient sites throughout the United States. The trial included 496 ARI patients with a clinically adjudicated final diagnosis, and 170 subjects without an ARI. Participants with ARIs were diagnostically tested with FebriDx as well as multiplex-PCR (polymerase chain reaction) testing and culture algorithm designed to identify 28 different pathogens. The results of this trial have been published in the peer-reviewed journal JAMA Open Network as an Original Investigation entitled Diagnostic accuracy of a bacterial and viral biomarker Point-of-Care test in the outpatient setting (doi:10.1001/jamanetworkopen.2022.34588). In this study FebriDx demonstrated sensitivity of 93.2% and specificity of 88.4% for bacterial infections, providing a negative predictive value (NPV) of 98.7%. For viral ARIs, FebriDx demonstrated sensitivity of 70.3%, specificity of 88.0% and an NPV of 66.7%. Major Estimate Revision • Sep 01
Consensus revenue estimates fall by 32% The consensus outlook for revenues in 2023 has deteriorated. 2023 revenue forecast decreased from US$9.90m to US$6.78m. Forecast losses increased from -US$0.09 to -US$0.11 per share. Medical Equipment industry in Australia expected to see average net income growth of 22% next year. Consensus price target down from AU$0.30 to AU$0.077. Share price fell 14% to AU$0.05 over the past week. Reported Earnings • Aug 26
Full year 2022 earnings: Revenues exceed analysts expectations while EPS lags behind Full year 2022 results: US$0.30 loss per share (down from US$0.10 loss in FY 2021). Revenue: US$11.6m (down 38% from FY 2021). Net loss: US$45.7m (loss widened 203% from FY 2021). Revenue exceeded analyst estimates by 18%. Earnings per share (EPS) missed analyst estimates by 194%. Over the next year, revenue is expected to shrink by 15% compared to a 16% growth forecast for the Medical Equipment industry in Australia. Announcement • Aug 26
Lumos Diagnostics Holdings Limited, Annual General Meeting, Oct 28, 2022 Lumos Diagnostics Holdings Limited, Annual General Meeting, Oct 28, 2022. Announcement • Aug 08
Lumos Files Appeal to the Food and Drug Administration for FebriDx Lumos Diagnostics announced that it has filed an appeal to the US Food and Drug Administration (FDA) regarding its decision not to grant clearance to market FebriDx® in the US based on the Company's recent 510(k) application. In July, Lumos announced that, following its review of Lumos' 510(k) application and the FDA's concerns regarding possible risks associated with false negative viral infection test results, the FDA determined that FebriDx did not demonstrate equivalence to the predicate device and consequently it was not granted clearance for marketing in the US. Lumos continues to believe that FebriDx has an important role as an aid to differentiate bacterial from viral infections and to assist with initiatives focused on improving antibiotic stewardship. In view of this, the Company is continuing to pursue options to secure regulatory clearance to market FebriDx in the US, including the filing of this appeal to the decision that was handed down by the FDA in July. The outcome of this appeal application is expected in fourth quarter of current year 2022. Price Target Changed • Jul 15
Price target decreased to AU$0.30 Down from AU$0.37, the current price target is an average from 2 analysts. New target price is 426% above last closing price of AU$0.057. Stock is down 96% over the past year. The company is forecast to post a net loss per share of US$0.099 next year compared to a net loss per share of US$0.10 last year. Announcement • Jul 12
Lumos Diagnostics Announces FDA Decision for FebriDx Lumos Diagnostics has been advised by the US Food and Drug Administration (FDA) that, following its review of Lumos' 510(k) application, FebriDx® did not demonstrate substantial equivalence to the predicate device and consequently has not been granted clearance for marketing in the U.S. The company is currently reviewing the feedback provided by the FDA in order to determine the next steps. This decision was based on the FDA's evaluation of data for FebriDx during the review process. The proposed intended use of FebriDx is as an aid to differentiate bacterial from viral infections and the test met success criteria defined before the pandemic in accordance with the pre-submission. However, given the number of reported cases and deaths from SARS-CoV-2 in the U.S., the FDA expressed concerns regarding the risk that false negative viral infection test results could lead to missed opportunities to treat patients or contribute to the further spread of SARS-CoV-2 infections. Lumos has previously received regulatory registrations for the use of FebriDx in the UK, Europe, Canada, UAE, Brazil and Australia. In light of these concerns, and Lumos' belief in the potential of this product to assist in addressing the global challenge of antimicrobial resistance, Lumos is evaluating options to secure a potential regulatory clearance by the U.S. FDA for FebriDx. This is expected to include an appeal to the FDA that would result in a decision within 90 days of submission, or a potential new 510(k) submission. Led by CEO Doug Ward, the senior management team is currently conducting a deep dive into relevant correspondence between Lumos and the FDA to ensure Lumos has the most comprehensive and appropriate evidence to address the FDA's feedback as part of an appeal process. Major Estimate Revision • Jul 09
Consensus revenue estimates fall by 33% The consensus outlook for revenues in 2022 has deteriorated. 2022 revenue forecast decreased from US$21.0m to US$14.2m. Forecast losses increased from -US$0.11 to -US$0.15 per share. Medical Equipment industry in Australia expected to see average net income decline 22% next year. Consensus price target up from AU$0.37 to AU$0.39. Share price rose 14% to AU$0.17 over the past week. Announcement • Jun 28
Lumos Diagnostics Holdings Limited's ViraDx Receives Interim Order Authorisation in Canada Lumos Diagnostics has received Interim Order authorization from Health Canada for its ViraDx three-in-one rapid antigen test for COVID-19/Flu A/Flu B in Canada. Subject to demand in Canada, Lumos is ready to commence production and shipping of ViraDx for use by healthcare professionals in Canada where it will be distributed by the Company's established Canadian distribution partners. ViraDx is currently under review by the U.S. FDA for Emergency Use Authorisation. If successful, Lumos intends to expand its North American sales and marketing efforts to include U.S. healthcare providers in hospitals and outpatient care settings that serve patients with acute respiratory infections. Announcement • Jun 22
Lumos Diagnostics Holdings Limited Appoints Doug Ward as CEO Lumos Diagnostics Holdings Limited announced that its Board of Directors has appointed Doug Ward, a highly experienced diagnostics executive, to serve as CEO. Mr. Ward has held executive positions including CEO during his more than 30-year career. Most recently he served as Vice President, Strategy and Business Development at Hologic where he led a global team responsible for fostering innovation in womens healthcare to improve clinical results. Prior to joining Hologic, Mr. Ward was the CEO of Personal Genome Diagnostics (PGDx) where he led the organizations transformation from a clinical laboratory testing service into a fully functional molecular in vitro diagnostics company. Mr. Ward joins Lumos Diagnostics at a pivotal time in the Companys history. Lumos is actively preparing for the commercial launch of its novel point-of-care test, FebriDx, in the U.S. pending the receipt of a 510(k) clearance from the FDA. In addition, applications for regulatory clearance of Lumos ViraDx and CoviDx point-of-care tests have been filed in key markets such as Canada and Australia. Announcement • Jun 07
Lumos Diagnostics Holdings Limited Appoints Doug Ward as CEO Lumos Diagnostics Holdings Limited announced that Doug Ward, an experienced commercial diagnostics executive, has been appointed to the CEO role and will commence with Lumos in mid-June following completion of his notice obligations to his current employer. Doug brings over 30 years of experience in the diagnostics and life sciences industries, and has held senior executive roles with leading, multinational healthcare companies including Roche /Ventana Medical, GE, Siemens, Bayer, Chiron and Hologic. Announcement • Feb 28
Lumos Diagnostics Announces That It Received Market Authorization for the FebriDx® Test from Brazil's Health Regulatory Agency, ANVISA Lumos Diagnostics announced that it received market authorization for the FebriDx® test from Brazil's Health Regulatory Agency, ANVISA. FebriDx is a rapid 10-minute point-of-care test that can aid healthcare professionals in detecting and differentiating bacterial from viral respiratory infections from a single fingerstick drop of blood--quickly providing results and helping guide care decisions. FebriDx is an all-in-one test that measures a patient's immune response to acute respiratory infections without any additional instruments or lab equipment. When used as part of a clinical exam, FebriDx can help healthcare professionals manage patients with a wide range of acute respiratory symptoms such as sore throat, cough and sinus congestion. With ANVISA's market authorization, FebriDx is available to qualified healthcare providers across Brazil, and is also approved by the corresponding regulatory agencies and available to qualified healthcare providers in the UK, Europe, Canada, Australia and UAE. An application for U.S. FDA 510(k) regulatory clearance is under review with an outcome expected during FY2022. For bacterial infections, FebriDx has been shown to provide a 97-99% negative predictive value (NPV), allowing healthcare professionals to confidently rule out bacterial infections for their patients. The ability to rule out bacterial infections is especially important during the respiratory (cold and flu) season because it can help reduce the use of medically unnecessary antibiotics. Recently, an independent meta-analysis of data from five, investigator-led clinical studies involving 2,309patients titled "FebriDx for rapid screening of patients with suspected COVID-19 upon hospital admission: systematic literature review and meta-analysis" has been published in the peer-reviewed Journal of Hospital Infection. This study concluded that, in addition to its intended use for differentiating bacterial from viral respiratory infections, FebriDx may have clinical value for the rapid screening of patients with suspected COVID-19 in acute care settings. Announcement • Feb 16
Lumos Diagnostics Announces Appointment of Barrie Lambert as Chief Financial Officer for the Company Lumos Diagnostics (‘Lumos’ or the ‘Company’) announced that Barrie Lambert has been appointed as Chief Financial Officer (CFO) for the Company. Barrie Lambert has extensive experience in leading rapid growth global, publicly traded companies and, for the past five years has been the CFO of Planet Innovation, one of the founding shareholders in Lumos Diagnostics. As a consequence of his role in Planet Innovation, Barrie is familiar with the historical operations and finances of Lumos Diagnostics and was involved in supporting Lumos' with its Initial Public Offering. In this global role, Barrie will focus his efforts across the business including extensive periods in the US working closely with Lumos finance and executive leadership teams. Announcement • Feb 11
Lumos Diagnostics Holdings Limited Resignation Rob Sambursky from its Board Lumos Diagnostics Holdings Limited announced Rob Sambursky has resigned from the Lumos board of directors to focus on the management of the company's operations as chief executive officer (CEO). There are no changes to Mr. Sambursky's current remuneration terms. In view of these increasing operational demands, Rob has elected to step down from board to focus on activities that will support progressing high-impact commercial opportunities. Announcement • Jan 31
Lumos Diagnostics Holdings Limited Announces Change in Reporting Currency Lumos Diagnostics announced that, in accordance with AASB 108 `Accounting Policies' it has voluntarily changed its presentation currency from Australian dollars to US dollars. Given that the Company's revenue and most of its costs are denominated in US dollars, the Board believes that the change will give investors and other stakeholders a clearer understanding of Lumos' performance over time. The change means that financial information in the Company's quarterly reports commencing from the quarter ended 31 December 2021, as well as its annual and interim financial reports, will be presented in US dollars. For comparative purposes, restated historical information will be included in the Half Year report for the six months ended 31 December 2021 and the Annual Report for the year ended 30 June 2022. Announcement • Dec 23
Lumos Diagnostics Provides ViraDx Development and FebriDx Regulatory Update Lumos Diagnostics announced that it has completed all the development, verification and validation activities to support regulatory submissions for ViraDx, a three-in-one COVID-19/Flu A/Flu B rapid antigen test. Regulatory submissions are underway in the U.S. and Canada where ViraDx falls into a category that is prioritized for regulatory reviews. ViraDx is a 15-minute, three-in-one COVID-19/Flu A/Flu B rapid antigen test for use by qualified healthcare professionals to assess patients with acute respiratory symptoms. Following necessary regulatory authorizations, ViraDx may complement Lumos' FebriDx test. FebriDx is an all-in-one, 10-minute test that measures a patient's immune response to acute respiratory infections (ARIs) using a patented dual biomarker technology without any additional instruments or equipment. When used as part of a clinical exam, FebriDx helps healthcare professionals manage patients with a wide range of acute respiratory symptoms such as sore throat, acute cough and sinus congestion. For bacterial infections, FebriDx provides a 99% negative predictive value (NPV), allowing healthcare professionals to confidently rule out bacterial infections for their patients. The ability to rule out bacterial infection is especially important during the respiratory (cold and flu) season because it can help reduce the use of medically unnecessary antibiotics. FebriDx is manufactured in the U.S. in ISO 13485 and MDSA-certified facilities. FebriDx is under review with the U.S. FDA and not cleared for use in the U.S. Board Change • Nov 01
High number of new and inexperienced directors There are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. 1 experienced director. No highly experienced directors. Executive Chairman of the Board Sam Lanyon is the most experienced director on the board, commencing their role in 2019. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Board Change • Oct 01
High number of new and inexperienced directors There are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. 1 experienced director. No highly experienced directors. Executive Chairman of the Board Sam Lanyon is the most experienced director on the board, commencing their role in 2019. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Announcement • Sep 23
FDA Deprioritises Lumos Request for Emergency Use Authorization (EUA) for the CoviDx SARS-CoV-2 Rapid Antigen Test Lumos Diagnostics Holdings Limited announced that it has received correspondence from the U.S. Food and Drug Administration (FDA) indicating that the FDA has deprioritised Lumos' request for Emergency Use Authorization (EUA) for the CoviDxTM SARS-CoV-2 Rapid Antigen Test (CoviDxTM) and has ceased review of the EUA at this time. The company is in active dialogue with the FDA and is preparing additional data in support of the application. The CoviDx test is currently available in Europe through its CE Mark approval and is undergoing regulatory review in other markets. 