New Risk • Jun 26
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 Share price has been highly volatile over the past 3 months (17% average weekly change). Revenue is less than US$1m (AU$411k revenue, or US$283k). Market cap is less than US$10m (AU$9.41m market cap, or US$6.48m). Minor Risk Shareholders have been diluted in the past year (27% increase in shares outstanding). New Risk • May 12
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: AU$13.7m (US$9.88m) 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 Revenue is less than US$1m (AU$411k revenue, or US$297k). Market cap is less than US$10m (AU$13.7m market cap, or US$9.88m). Minor Risks Share price has been volatile over the past 3 months (15% average weekly change). Shareholders have been diluted in the past year (27% increase in shares outstanding). New Risk • Apr 18
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 27% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m (AU$411k revenue, or US$295k). Minor Risks Share price has been volatile over the past 3 months (14% average weekly change). Shareholders have been diluted in the past year (27% increase in shares outstanding). Market cap is less than US$100m (AU$19.4m market cap, or US$13.9m). Ankündigung • Apr 17
Firebrick Pharma Limited has completed a Follow-on Equity Offering in the amount of AUD 1.51692 million. Firebrick Pharma Limited has completed a Follow-on Equity Offering in the amount of AUD 1.51692 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 21,636,603
Price\Range: AUD 0.047
Discount Per Security: AUD 0.00282
Security Features: Attached Options
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 10,638,298
Price\Range: AUD 0.047
Discount Per Security: AUD 0.00282
Security Features: Attached Options
Transaction Features: Subsequent Direct Listing New Risk • Apr 15
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 Risk Revenue is less than US$1m (AU$411k revenue, or US$293k). Minor Risks Share price has been volatile over the past 3 months (14% average weekly change). Market cap is less than US$100m (AU$16.9m market cap, or US$12.1m). Ankündigung • Mar 31
Firebrick Pharma Limited has filed a Follow-on Equity Offering in the amount of AUD 1.5 million. Firebrick Pharma Limited has filed a Follow-on Equity Offering in the amount of AUD 1.5 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 31,914,893
Price\Range: AUD 0.047
Discount Per Security: AUD 0.00282
Security Features: Attached Options
Transaction Features: Subsequent Direct Listing New Risk • Feb 25
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$2.3m 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$2.3m free cash flow). Revenue is less than US$1m (AU$411k revenue, or US$292k). Market cap is less than US$10m (AU$13.4m market cap, or US$9.51m). Minor Risk Shareholders have been diluted in the past year (20% increase in shares outstanding). Reported Earnings • Feb 25
First half 2026 earnings released: AU$0.005 loss per share (vs AU$0.007 loss in 1H 2025) First half 2026 results: AU$0.005 loss per share (improved from AU$0.007 loss in 1H 2025). Net loss: AU$1.26m (loss narrowed 13% from 1H 2025). Over the last 3 years on average, earnings per share has increased by 57% per year but the company’s share price has fallen by 36% per year, which means it is significantly lagging earnings. New Risk • Feb 20
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: AU$13.4m (US$9.43m) 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 Revenue is less than US$1m (AU$516k revenue, or US$363k). Market cap is less than US$10m (AU$13.4m market cap, or US$9.43m). Minor Risk Shareholders have been diluted in the past year (20% increase in shares outstanding). Board Change • Jan 05
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. 2 non-independent directors. Independent Non-Executive Director Rick Legleiter was the last independent director to join the board, commencing their role in 2025. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Ankündigung • Oct 16
Firebrick Pharma Limited has filed a Follow-on Equity Offering in the amount of AUD 0.102 million. Firebrick Pharma Limited has filed a Follow-on Equity Offering in the amount of AUD 0.102 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 1,200,000
Price\Range: AUD 0.085
Transaction Features: Subsequent Direct Listing Ankündigung • Sep 29
Firebrick Pharma Limited, Annual General Meeting, Nov 26, 2025 Firebrick Pharma Limited, Annual General Meeting, Nov 26, 2025. Reported Earnings • Aug 31
Full year 2025 earnings released: AU$0.012 loss per share (vs AU$0.007 loss in FY 2024) Full year 2025 results: AU$0.012 loss per share (further deteriorated from AU$0.007 loss in FY 2024). Revenue: AU$524.7k (down 81% from FY 2024). Net loss: AU$2.63m (loss widened 124% from FY 2024). Over the last 3 years on average, earnings per share has increased by 50% per year but the company’s share price has fallen by 39% per year, which means it is significantly lagging earnings. Ankündigung • Aug 30
Firebrick Pharma Limited has completed a Follow-on Equity Offering in the amount of AUD 1.4 million. Firebrick Pharma Limited has completed a Follow-on Equity Offering in the amount of AUD 1.4 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 22,222,222
Price\Range: AUD 0.063
Security Features: Attached Options
Transaction Features: Subsequent Direct Listing New Risk • Aug 06
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 16% 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 Earnings have declined by 1.4% per year over the past 5 years. Revenue is less than US$1m (AU$1.1m revenue, or US$735k). Minor Risks Share price has been volatile over the past 3 months (15% average weekly change). Shareholders have been diluted in the past year (16% increase in shares outstanding). Market cap is less than US$100m (AU$17.7m market cap, or US$11.5m). New Risk • Jun 27
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Australian stocks, typically moving 13% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 1.4% per year over the past 5 years. Revenue is less than US$1m (AU$1.1m revenue, or US$740k). Market cap is less than US$10m (AU$13.5m market cap, or US$8.82m). Minor Risk Share price has been volatile over the past 3 months (13% average weekly change). Ankündigung • Jun 26
Firebrick Pharma Limited has completed a Follow-on Equity Offering in the amount of AUD 0.195 million. Firebrick Pharma Limited has completed a Follow-on Equity Offering in the amount of AUD 0.195 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 3,095,238
Price\Range: AUD 0.063
Security Features: Attached Options
Transaction Features: Subsequent Direct Listing New Risk • Apr 09
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: AU$16.0m (US$9.65m) 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 1.4% per year over the past 5 years. Revenue is less than US$1m (AU$1.1m revenue, or US$684k). Market cap is less than US$10m (AU$16.0m market cap, or US$9.65m). Minor Risk Shareholders have been diluted in the past year (17% increase in shares outstanding). Ankündigung • Mar 05
Firebrick Pharma Limited announced that it expects to receive AUD 1.1 million in funding from Pharma Nutria N.a. (metro Manila Luzon), Inc. Firebrick Pharma Limited announce that it has secured an investment from Pharma Nutria N.A., Inc to issue 11,578,947 ordinary shares at a price of AUD 0.095 per share for gross proceeds of AUD 1,099,999.965 on March 4, 2025. The Shares are subject to a voluntary escrow of 12 months. The 11,578,947 Shares will represent 5.2% of all Firebrick shares outstanding and therefore PNAI will become a substantial shareholder in Firebrick. Reported Earnings • Feb 24
First half 2025 earnings released: AU$0.007 loss per share (vs AU$0.005 loss in 1H 2024) First half 2025 results: AU$0.007 loss per share (further deteriorated from AU$0.005 loss in 1H 2024). Revenue: AU$197.1k (down 89% from 1H 2024). Net loss: AU$1.45m (loss widened 61% from 1H 2024). Over the last 3 years on average, earnings per share has increased by 34% per year but the company’s share price has fallen by 42% per year, which means it is significantly lagging earnings. New Risk • Feb 21
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$2.0m 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$2.0m free cash flow). Earnings have declined by 1.4% per year over the past 5 years. Revenue is less than US$1m (AU$1.1m revenue, or US$720k). Minor Risks Share price has been volatile over the past 3 months (11% average weekly change). Shareholders have been diluted in the past year (17% increase in shares outstanding). Market cap is less than US$100m (AU$17.6m market cap, or US$11.3m). New Risk • Feb 10
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 14% 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 (17% increase in shares outstanding). Revenue is less than US$5m (AU$2.8m revenue, or US$1.7m). Market cap is less than US$100m (AU$17.9m market cap, or US$11.2m). Ankündigung • Oct 29
Firebrick Pharma Limited, Annual General Meeting, Nov 27, 2024 Firebrick Pharma Limited, Annual General Meeting, Nov 27, 2024. Ankündigung • Oct 17
Firebrick Pharma Limited has completed a Follow-on Equity Offering in the amount of AUD 0.1587 million. Firebrick Pharma Limited has completed a Follow-on Equity Offering in the amount of AUD 0.1587 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 2,885,454
Price\Range: AUD 0.055
Discount Per Security: AUD 0
Transaction Features: Subsequent Direct Listing Reported Earnings • Aug 31
Full year 2024 earnings released: AU$0.007 loss per share (vs AU$0.04 loss in FY 2023) Full year 2024 results: AU$0.007 loss per share (improved from AU$0.04 loss in FY 2023). Net loss: AU$1.18m (loss narrowed 83% from FY 2023). Ankündigung • May 17
Firebrick Pharma Limited has filed a Follow-on Equity Offering in the amount of AUD 0.8 million. Firebrick Pharma 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: 16,000,000
Price\Range: AUD 0.05
Transaction Features: Subsequent Direct Listing New Risk • Apr 17
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 17% 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$4.6m free cash flow). Earnings have declined by 34% per year over the past 5 years. Market cap is less than US$10m (AU$9.13m market cap, or US$5.85m). Minor Risks Share price has been volatile over the past 3 months (17% average weekly change). Shareholders have been diluted in the past year (5.5% increase in shares outstanding). Revenue is less than US$5m (AU$1.8m revenue, or US$1.2m). Ankündigung • Sep 15
Firebrick Pharma Limited Announces That Trial Statisticians Have Completed Their Efficacy Analysis of the Headline Results in the Phase 3 Trial of Nasodine® Nasal Spray as A Treatment for the Common Cold Firebrick Pharma Limited announced that trial statisticians have completed their efficacy analysis of the headline results in the Phase 3 trial of Nasodine® Nasal Spray as a treatment for the common cold. The analysis has shown that the trial did not meet its primary endpoint, which was the impact of Nasodine on overall cold severity (GSS) in subjects with a confirmed viral infection (ITTi). Based on the reported results, the placebo (sterile water) performed better than Nasodine. In the QoL (`quality-of-life') measure (functional impairment caused by a cold), the results were also in favour of the placebo in the ITTi. Similar enigmatic results were seen in other population subsets. The results provided to the Company are shown in the table titled: Trial Headline Results Summary. These results are compared in summary form with the previous (2019) Phase 3 trial in the table titled: Phase 3 Trial Comparisons on Key Endpoints. The 2019 trial used the same protocol and treatment regimen as the current (2022-23) trialand both trials were robust Phase 3 trials. The 2019 trial took place in Australia, so a comparison of the results with the current trial for Australian sites only has been undertaken (not shown in summary tables). In the 2019 trial, the GSS benefit of Nasodine in the viral-infected subjects (N=52) was 22.9% (p=0.048), but in the current trial, for Australian sites, the benefit was reversed, with the water placebo outperforming Nasodine by 22.7% in the ITTi (N=181), the result being statistically significant (p=0.024). The reported results also appear to conflict with the Company's recently reported Phase 2 COVID-19 trial, where Nasodine treatment led to 100% clearance of the SARS-CoV-2 virus from the nasal passages. That result was significantly better than the placebo (p=0.028), which was the same water placebo as used in the 2022-23 Phase 3 trial. The Company is concerned that the results are so confounding, unexpected and at odds with previous data that there may be a systematic error or other issue in the data, and a detailed analysis is now underway to try to identify any causes of such an error. To that end, the Company is working with the Contract Research Organisation (CRO) responsible for trial governance and other service providers to thoroughly investigate the trial results. At this time, there is no evidence that the placebo and Nasodine treatments were switched during production, distribution or treatment. Reported Earnings • Aug 30
Full year 2023 earnings released: AU$0.04 loss per share (vs AU$0.033 loss in FY 2022) Full year 2023 results: AU$0.04 loss per share (further deteriorated from AU$0.033 loss in FY 2022). Net loss: AU$6.80m (loss widened 79% from FY 2022). Ankündigung • Jul 22
Firebrick Update on Administrative Appeals Tribunal Process Firebrick Pharma Limited announced that the scheduled conciliation meeting with the TGA (Therapeutic Goods Administration), which was moderated by the Administrative Appeals Tribunal (AAT) took place in Sydney on 19 July 2023. The meeting between the parties was cordial with a frank exchange on the issues relating to the approval of Nasodine Nasal Spray ("Nasodine"). Confidential discussions between the parties are ongoing and Firebrick is hopeful that an agreement on the approval of Nasodine can be reached. This announcement was authorized for release by Dr. Peter Molloy, Executive Chairman, Firebrick Pharma Limited. Ankündigung • May 16
Firebrick Pharma Limited, Annual General Meeting, Jun 20, 2023 Firebrick Pharma Limited, Annual General Meeting, Jun 20, 2023, at 11:00 E. Australia Standard Time. Agenda: To consider the ratification of tranche 1 placement shares; to consider the issue of tranche 2 placement shares to related party Stephen Goodall; and to consider the issue of tranche 2 placement shares to related party Peter Molloy. 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. 4 non-independent directors. Non-Executive Director Richard Treagus was the last director to join the board, commencing their role in 2022. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model. Ankündigung • Nov 14
Firebrick Pharma Limited Announces CFO Changes Firebrick Pharma Limited advises that Ms Kyla Garic has resigned her position as Chief Financial Officer (CFO). and through her company, Onyx Corporate, the provision of accounting and bookkeeping services for Firebrick, with an effective date of 25 January 2023. The Company also advise that Mr. Kavi Bekarma will take over the CFO duties and through his company, TripleEight Corporate, the provision of accounting and bookkeeping services for the Company from 1 December 2022 to allow for a smooth handover before 25 January 2023. Kavi Bekarma is the Managing Director of TripleEight Corporate, a corporate accounting firm offering various services for listed and non-listed companies in the mining, oil and gas, technology and biotechnology sectors. Mr. Bekarma is a Chartered Accountant of Australia and New Zealand, holds a Masters of Professional Accounting and a Bachelor's Degree in Management with Information Systems. Ankündigung • Nov 01
Firebrick Pharma Limited Provides Update on its Phase 3 Clinical Trial of Nasodine Nasal Spray in Treatment of Common Cold Firebrick Pharma Limited provided an update on its Phase 3 clinical trial of Nasodine Nasal Spray in the treatment of the common cold. As at 31 October, the trial has so far successfully recruited 224 subjects with early-stage colds into the ITT (Intent-To-Treat population), with an estimated 100 qualifying for the primary endpoint population of those with confirmed viral infection (ITTi), based on PCR of a throat and nasal swab. This represents at least 51% of the trial's full recruitment target of 196 subjects in the ITTi. The primary endpoint for the trial is the benefit of Nasodine treatment on overall cold severity 2 in the ITT. In the previous Phase 3 trial, Nasodine produced a statistically significant benefit in the 52 subjects who had confirmed viral infection (see p. 20 of the Company's Prospectus). The current Phase 3 trial was designed to support international registration of Nasodine and if completed by mid-2023, the EU application for approval could be filed by the end of calendar 2023. The US application will require a further Phase 3 trial to be conducted in the US. Ankündigung • Oct 27
Rebrick Pharma Limited Announces Nasodine Patent Granted in Singapore Firebrick Pharma Limited announced that its patent covering Nasodine® Nasal Spray ("Nasodine") as a treatment and preventative for the common cold has been granted in Singapore. The patent is still pending in Canada and Japan. The pending application in China has now been withdrawn, following a recent assessment of the likelihood and costs of gaining any commercially-useful protection in that market. Granted claims include treating and preventing colds, reducing the viral load of common cold viruses, prevention of secondary complications of colds, and reducing the risk of serious complications in at-risk populations. Ankündigung • Sep 28
Firebrick Pharma Limited, Annual General Meeting, Nov 23, 2022 Firebrick Pharma Limited, Annual General Meeting, Nov 23, 2022, at 15:00 AUS Eastern Standard Time. Location: Level 18, 600 Bourke Street, Melbourne, Melbourne Victoria Australia Ankündigung • May 26
Firebrick Appoints Richard Treagus as Director Firebrick Pharma Limited announced the appointment of Dr. Richard Treagus as a non-executive director on the Firebrick board of directors, with effect from 1 June 2022. Dr. Treagus was previously Commercial Director for Aspen Pharmacare in South Africa, responsible for sales and marketing of pharmacy and consumer products. More recently, from 2006 to 2012, he was CEO of Acrux Limited, which grew 10-fold in value during his tenure and from 2013 to 2020, he was Executive Chairman of Neuren Pharmaceuticals Limited, which grew 6-fold in value during his tenure. Ankündigung • May 04
Firebrick Pharma Limited Starts Phase 3 Common Cold Trial Firebrick Pharma Limited announced that the first patient has been recruited into its confirmatory Phase 3 trial for Nasodine® Nasal Spray ("Nasodine") as a treatment for the common cold. The randomized controlled Phase 3 trial expects to recruit up to 450 adult subjects with early cold symptoms to achieve a target treatment population of 196 subjects, who are confirmed by PCR, to have a viral cold. The primary endpoint of the trial will be the impact of Nasodine treatment (3 sprays per nostril, 4 times daily for 5 days) on overall cold severity in the viral-infected population. Overall cold severity will be measured using the Global Severity Score (GSS) from the WURSS-21 cold severity survey. The trial is a multi-centre international study, with recruitment planned at three sites in Australia and two sites in South Africa. The first site to recruit patients is in Adelaide, with Victorian and South African sites planned to come online over the next month. Trial recruitment at all sites is expected to be completed by October this year. Any subjects found by PCR testing to have SARS-CoV-2 infection (COVID-19) will be excluded from the population for assessment of the primary endpoint but retained in the overall study population for assessment of some secondary endpoints. The company has previously completed a Phase 3 trial for the common cold in 2019 at sites in Adelaide and Brisbane. Following the completion of the trial, Firebrick filed a registration dossier with the TGA to determine whether Nasodine could be approved as an OTC (over the counter) treatment for the common cold based on then current data. The TGA has since provided advice to the Company that it has no concerns with the quality or safety of Nasodine, but that clinical efficacy was not satisfactorily established. This second Phase 3 trial was originally intended to support international regulatory approvals, but if the Australian appeal is unsuccessful, it will also be used to support approval in Australia. Board Change • Apr 27
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. 4 non-independent directors. Non-Executive Director Phyllis Gardner 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. Ankündigung • Apr 26
Firebrick Pharma Limited Starts COVID-19 Trial of Nasodine Firebrick Pharma Limited announced that the first patient had been recruited into its Phase 2 clinical trial in South Africa of Nasodine® Nasal Spray ("Nasodine") for the management of COVID-19. The trial is scheduled to recruit up to 210 adults who are COVID-positive by Rapid Antigen Test (RAT) to achieve a target treatment population of 144 subjects who will be confirmed by viral culture to be shedding SARS-CoV-2 virus. Depending on patient recruitment, the trial could be completed by August 2022. The study is a randomised, placebo-controlled Phase 2 trial, titled: `Reduction of nasal shedding of SARS-CoV-2 in COVID-19 positive patients by the use of Nasodine® (povidone- iodine 0.5%) Nasal Spray.' The short title for the trial is `Nasodine for Elimination of COVID- 19 Shedding study' or `NASO-ELOCS'. The primary aim of the trial will be to show that frequent Nasodine application (every 2 hours,up to eight-times-daily) over three days leads to a significant reduction in nasal shedding of SARS-CoV-2 virus, compared with a placebo nasal spray. Secondary aims will include whether Nasodine treatment (compared with placebo) reduces the number of days to a negative RAT and increases the percentage of subjects who have cleared the virus from the upper respiratory tract within 5 days, based on a combined throat and nasal swab. Prior to gaining regulatory approval for any role in the management of COVID-19, Nasodine would likely need to undergo a confirmatory Phase 3 trial in a specific aspect of COVID-19 that is clinically relevant to the management of the disease. Nasodine has already completed a Phase 3 clinical trial as a treatment for the common cold and Firebrick is preparing to start a second Phase 3 common cold trial this year, in order to support international regulatory approvals, and if the Australian appeal is unsuccessful it will also be used to support approval in Australia. Ankündigung • Feb 11
Firebrick Pharma Limited Announces the Results of in Vitro Studies of Nasodine® Nasal Spray Firebrick Pharma Limited announced that the results of in vitro studies of Nasodine® Nasal Spray (povidone-iodine 0.5%) against SARS-CoV-2, and a pilot human study in a small number of COVID-19 subjects, had been published in the Australian Journal of Otolaryngology (AJO). The in vitro experiments showed a 15-second exposure to Nasodine Nasal Spray (Nasodine) reduced infectivity of SARS-CoV-2 by 99.97%, while a 60-second exposure completely eliminated viral infectivity. The subsequent in vivo pilot study of six COVID-19 patients who were shedding the virus from the nose, showed that a single Nasodine dose (4 sprays per nostril) reduced viral shedding in 5 of the 6 subjects (83%) at 5 minutes after the dose, with an overall 79% reduction in viral shedding at one hour after the dose. Ankündigung • Feb 01
Firebrick Pharma Limited Announces That Its Planned Clinical Trial of Nasodine Nasal Spray (Povidone-Iodine 0.5%) in Covid-19 Patients in South Africa, Had Received Approval to Proceed from the South African Health Products Regulatory Authority Firebrick Pharma Limited announced that its planned clinical trial of Nasodine Nasal Spray (povidone-iodine 0.5%) in COVID-19 patients in South Africa, had received approval to proceed from the South African Health Products Regulatory Authority (SAHPRA). The trial is titled: "Reduction of nasal shedding of SARS-CoV-2 in COVID-19 positive patients by the use of Nasodine® (povidone-iodine 0.5%) Nasal Spray." It is intended to demonstrate that frequent, repeated application of Nasodine Nasal Spray ("Nasodine") in COVID-19 subjects who are RAT-positive, leads to reduction or elimination of nasal shedding of the Sars-CoV-2 virus. The SAHPRA approval specifically allows Firebrick Pharma to import Nasodine into South Africa for the trial and to administer the product to patients during the trial, according to the trial protocol submitted to SAHPRA. As noted in the Company's prospectus (section 2.4.4(b)), prior to commencing the trial the Company will also need approval from the local clinical Ethics Committee, which has been applied for but has yet to be received. Board Change • Jan 28
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. 3 non-independent directors. Non-Executive Director Phyllis Gardner 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.