Breakeven Date Change • May 22
Forecast to breakeven in 2028 The 3 analysts covering Botanix Pharmaceuticals expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 39% per year to 2027. The company is expected to make a profit of AU$3.40m in 2028. Average annual earnings growth of 76% is required to achieve expected profit on schedule. Breakeven Date Change • May 02
No longer forecast to breakeven The 3 analysts covering Botanix Pharmaceuticals no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of AU$500.0k in 2028. New consensus forecast suggests the company will make a loss of AU$8.50m in 2028. Announcement • Apr 20
Botanix Pharmaceuticals Limited has completed a Follow-on Equity Offering in the amount of AUD 4.999999 million. Botanix Pharmaceuticals Limited has completed a Follow-on Equity Offering in the amount of AUD 4.999999 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 14,341,646
Price\Range: AUD 0.06
Discount Per Security: AUD 0.0009
Security Features: Attached Options
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 68,991,667
Price\Range: AUD 0.06
Discount Per Security: AUD 0.0009
Security Features: Attached Options Major Estimate Revision • Apr 18
Consensus EPS estimates fall by 15% The consensus outlook for earnings per share (EPS) in fiscal year 2026 has deteriorated. 2026 revenue forecast decreased from AU$40.3m to AU$36.9m. Losses expected to increase from AU$0.02 per share to AU$0.023. Pharmaceuticals industry in Australia expected to see average net income decline 24% next year. Consensus price target down from AU$0.50 to AU$0.49. Share price rose 2.8% to AU$0.037 over the past week. Price Target Changed • Apr 17
Price target increased by 30% to AU$0.65 Up from AU$0.50, the current price target is an average from 3 analysts. New target price is 1,643% above last closing price of AU$0.037. Stock is down 91% over the past year. The company is forecast to post a net loss per share of AU$0.023 next year compared to a net loss per share of AU$0.047 last year. New Risk • Apr 16
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 44% 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 Risk Shareholders have been substantially diluted in the past year (44% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (AU$7.6m net loss in 2 years). Share price has been volatile over the past 3 months (15% average weekly change). Market cap is less than US$100m (AU$94.9m market cap, or US$68.2m). Announcement • Apr 10
Botanix Pharmaceuticals Limited has completed a Follow-on Equity Offering in the amount of AUD 39.781579 million. Botanix Pharmaceuticals Limited has completed a Follow-on Equity Offering in the amount of AUD 39.781579 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 247,994,473
Price\Range: AUD 0.06
Discount Per Security: AUD 0.0036
Security Features: Attached Options
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 406,698,517
Price\Range: AUD 0.06
Discount Per Security: AUD 0.0036
Security Features: Attached Options
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 8,333,333
Price\Range: AUD 0.06
Discount Per Security: AUD 0.0036
Security Features: Attached Options
Transaction Features: Subsequent Direct Listing Major Estimate Revision • Mar 06
Consensus EPS estimates upgraded to AU$0.02 loss, revenue downgraded The consensus outlook for fiscal year 2026 has been updated. 2026 revenue forecast fell from AU$40.8m to AU$40.3m. 2026 losses expected to reduce from -AU$0.032 to -AU$0.02 per share. Pharmaceuticals industry in Australia expected to see average net income decline 36% next year. Consensus price target down from AU$0.83 to AU$0.50. Share price was steady at AU$0.057 over the past week. New Risk • Mar 05
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 2 years. Trailing 12-month net loss: AU$89m Forecast net loss in 2 years: AU$7.8m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (AU$7.8m net loss in 2 years). Share price has been volatile over the past 3 months (15% average weekly change). Shareholders have been diluted in the past year (21% increase in shares outstanding). Market cap is less than US$100m (AU$122.0m market cap, or US$86.4m). Price Target Changed • Mar 04
Price target decreased by 43% to AU$0.50 Down from AU$0.87, the current price target is an average from 3 analysts. New target price is 803% above last closing price of AU$0.055. Stock is down 86% over the past year. The company is forecast to post a net loss per share of AU$0.033 next year compared to a net loss per share of AU$0.047 last year. Reported Earnings • Mar 02
First half 2026 earnings: Revenues exceed analysts expectations while EPS lags behind First half 2026 results: AU$0.017 loss per share (in line with 1H 2025). Revenue: AU$16.5m (up AU$16.1m from 1H 2025). Net loss: AU$33.2m (loss widened 7.5% from 1H 2025). Revenue exceeded analyst estimates by 5.5%. Earnings per share (EPS) missed analyst estimates by 69%. Revenue is forecast to grow 72% p.a. on average during the next 3 years, compared to a 46% growth forecast for the Pharmaceuticals industry in Australia. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 59 percentage points per year, which is a significant difference in performance. New Risk • Feb 28
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 2 years. Trailing 12-month net loss: AU$89m Forecast net loss in 2 years: AU$39k This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (AU$39k net loss in 2 years). Share price has been volatile over the past 3 months (15% average weekly change). Shareholders have been diluted in the past year (21% increase in shares outstanding). Market cap is less than US$100m (AU$124.2m market cap, or US$88.4m). New Risk • Feb 25
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 21% 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: Minor Risks Share price has been volatile over the past 3 months (15% average weekly change). Shareholders have been diluted in the past year (21% increase in shares outstanding). Revenue is less than US$5m (AU$5.8m revenue, or US$4.1m). Market cap is less than US$100m (AU$124.2m market cap, or US$87.7m). New Risk • Feb 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 15% 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: Minor Risks Less than 1 year of cash runway based on current free cash flow (-AU$80m). Share price has been volatile over the past 3 months (15% average weekly change). Revenue is less than US$5m (AU$5.8m revenue, or US$4.1m). Major Estimate Revision • Jan 29
Consensus EPS estimates fall by 12% The consensus outlook for fiscal year 2026 has been updated. 2026 expected loss increased from -AU$0.029 to -AU$0.032 per share. Revenue forecast unchanged at AU$41.5m. Pharmaceuticals industry in Australia expected to see average net income decline 17% next year. Consensus price target broadly unchanged at AU$0.87. Share price fell 15% to AU$0.11 over the past week. Major Estimate Revision • Oct 21
Consensus revenue estimates increase by 13% The consensus outlook for revenues in fiscal year 2026 has improved. 2026 revenue forecast increased from AU$43.7m to AU$49.5m. Forecast losses expected to reduce from -AU$0.03 to -AU$0.025 per share. Pharmaceuticals industry in Australia expected to see average net income decline 76% next year. Consensus price target of AU$0.89 unchanged from last update. Share price rose 3.3% to AU$0.15 over the past week. New Risk • Sep 17
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 19% 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 Risk Share price has been highly volatile over the past 3 months (19% average weekly change). Minor Risks Less than 1 year of cash runway based on current free cash flow (-AU$80m). Revenue is less than US$5m (AU$5.8m revenue, or US$3.9m). Breakeven Date Change • Sep 01
Forecast breakeven date pushed back to 2028 The 3 analysts covering Botanix Pharmaceuticals previously expected the company to break even in 2027. New consensus forecast suggests the company will make a profit of AU$55.3m in 2028. Average annual earnings growth of 91% is required to achieve expected profit on schedule. New Risk • Aug 31
New minor risk - Financial position The company has less than a year of cash runway based on its current free cash flow. Free cash flow: -AU$80m This is considered a minor 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: Minor Risks Less than 1 year of cash runway based on current free cash flow (-AU$80m). Share price has been volatile over the past 3 months (18% average weekly change). Revenue is less than US$5m (AU$5.8m revenue, or US$3.8m). Reported Earnings • Aug 31
Full year 2025 earnings: Revenues exceed analysts expectations while EPS lags behind Full year 2025 results: AU$0.047 loss per share (further deteriorated from AU$0.009 loss in FY 2024). Net loss: AU$86.4m (loss widened AU$72.5m from FY 2024). Products in clinical trials Phase III: 2 Revenue exceeded analyst estimates by 29%. Earnings per share (EPS) missed analyst estimates by 34%. Revenue is forecast to grow 52% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Pharmaceuticals industry in Australia. Over the last 3 years on average, earnings per share has fallen by 53% per year but the company’s share price has increased by 26% per year, which means it is well ahead of earnings. Announcement • Aug 30
Botanix Pharmaceuticals Limited, Annual General Meeting, Nov 20, 2025 Botanix Pharmaceuticals Limited, Annual General Meeting, Nov 20, 2025. Location: at the offices of bdo, level 9, mia yellagonga tower 2, 5 spring street, perth, western australia. Australia Announcement • Aug 25
Botanix Pharmaceuticals Limited Appoints Dr. Patricia Walker to the Board, Effective August 25, 2025 Botanix Pharmaceuticals Limited appointed Dr Patricia Walker, MD, PhD, to their Board of Directors, effective 25 August 2025. She brings extensive experience and learnings from previous board affiliations with leading dermatology companies. Her impactful thought leadership in dermatology is readily apparent with over 60 publications in medical and scientific journals and an outstanding number of learned lectures to her credit. Dr Walker is the recipient of over two dozen academic and professional honours. She brings a wealth of knowledge in drug development for key dermatology products, including Tazorac®, Botox Cosmetic, Juvéderm®, Hylaform®, Captique®, Lap-Band®, Inamed Silicone gel-filled breast implants, and Kybella from her engagements with Allergan, Allergan Medical Aesthetics, Inamed, and Kythera Biopharmaceuticals. Dr Walker also led the development of Botanix's lead product, SofdraTM (sofpironium) topical gel, 12.45% from a preclinical asset to Phase 3 prior to its acquisition by Botanix. Dr Walker previously served as Chief Medical Advisor for Botanix Pharmaceuticals through her consulting company, Walker Consulting, which continues to work with prominent dermatology pharmaceutical companies.Dr Walker completed her medical degree and dermatology residency training at the University of Iowa College of Medicine. She also completed a prestigious research fellowship at the National Institute of Health's Dermatology Branch. Dr Walker put her experience to work teaching the next generation of dermatologists as a member of the Clinical Faculty, Department of Dermatology, University of California, Irvine. Dr Walker has shown a great passion for the oversight of research and new product development all stages from discovery to global market approvals. She is also experienced in securing corporate financing, product licenses, joint development efforts and initial public offerings. Major Estimate Revision • Jul 30
Consensus revenue estimates decrease by 22% The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast fell from AU$5.75m to AU$4.47m. EPS estimate unchanged from -AU$0.035 per share at last update. Pharmaceuticals industry in Australia expected to see average net income decline 57% next year. Consensus price target down from AU$1.25 to AU$0.90. Share price fell 2.9% to AU$0.17 over the past week. New Risk • Jul 08
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 18% 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: Minor Risks Share price has been volatile over the past 3 months (18% average weekly change). Revenue is less than US$5m (AU$2.1m revenue, or US$1.4m). Announcement • Jun 10
Botanix Pharmaceuticals Limited announced that it expects to receive AUD 48 million in funding from Kreos Capital VII (Uk) Limited Botanix Pharmaceuticals Limited announced that it has entered into a documentation with Kreos Capital VII (UK) Limited and its related entity Kreos Capital for a loan facility of A$48 million on June 10, 2025. The Facility provides for an initial tranche of ~A$31 million, available upon closing and anticipated to be drawn down today (Tranche A) and a further ~A$15.5 million (Tranche B) available to be drawn down up to and including 1 October 2026 subject to draw down conditions. The company will issue warrants to acquire shares each with an exercise price of A$0.33 and with an expiry date five years from the date of issue, subject to the terms of the Warrant instrument. 3,030,303 Warrants will be issued on the Tranche A drawdown of the Facility and a further 1,515,151 Warrants will be issued on satisfaction of the Tranche B drawdown conditions. Breakeven Date Change • Jun 04
Forecast breakeven date pushed back to 2027 The analyst covering Botanix Pharmaceuticals previously expected the company to break even in 2026. New forecast suggests the company will make a profit of AU$66.8m in 2027. Average annual earnings growth of 110% is required to achieve expected profit on schedule. Announcement • Apr 24
Botanix Pharmaceuticals Limited has completed a Follow-on Equity Offering in the amount of AUD 40 million. Botanix Pharmaceuticals Limited has completed a Follow-on Equity Offering in the amount of AUD 40 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 121,212,122
Price\Range: AUD 0.33
Discount Per Security: AUD 0.0165
Transaction Features: Subsequent Direct Listing Announcement • Apr 15
Botanix Pharmaceuticals Limited has filed a Follow-on Equity Offering in the amount of AUD 40 million. Botanix Pharmaceuticals Limited has filed a Follow-on Equity Offering in the amount of AUD 40 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 121,212,122
Price\Range: AUD 0.33
Discount Per Security: AUD 0.0165
Transaction Features: Subsequent Direct Listing Major Estimate Revision • Mar 19
Consensus revenue estimates decrease by 16%, EPS upgraded The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast fell from AU$24.3m to AU$20.4m. EPS estimate increased from -AU$0.003 to -AU$0.0003 per share. Pharmaceuticals industry in Australia expected to see average net income decline 34% next year. Consensus price target of AU$0.65 unchanged from last update. Share price was steady at AU$0.41 over the past week. Breakeven Date Change • Mar 12
Forecast breakeven date pushed back to 2026 The analyst covering Botanix Pharmaceuticals previously expected the company to break even in 2025. New forecast suggests the company will make a profit of AU$34.3m in 2026. Average annual earnings growth of 121% is required to achieve expected profit on schedule. Recent Insider Transactions • Jan 18
MD & Executive Chairman recently sold AU$1.7m worth of stock On the 15th of January, Vincent Ippolito sold around 4m shares on-market at roughly AU$0.44 per share. This transaction amounted to 20% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was Vincent's only on-market trade for the last 12 months. Announcement • Oct 03
Botanix Pharmaceuticals Limited Announces Management Appointments Botanix Pharmaceuticals Limited announced the appointment of Kevin Wojciechowski Head of HCP Marketing and Sales Training Mr. Wojciechowski joins the company from Avalere Health after being the Executive Director of Marketing and Sales Training at Journey Medical Corporation as well as Senior Product Marketing Manager with Medicis, amongst other senior sales training and field operations management roles with Stryker, Cephalon and J&J. Darin Van Arsdalen Director of Sales Operations Mr. Van Arsdalen comes to the company with previous experience at Incyte, Strata Skin Sciences, Encore Dermatology and Graceway Pharmaceuticals where he held senior sales operations and planning roles responsible for forecasting, field operations, alignments and data management. With more than 20 years specialised experience in sales force optimisation, Mr. Van Arsdalen will be heavily involved in development of tools for reporting around the commercialisation of Sofdra. Announcement • Sep 10
Botanix Pharmaceuticals Limited, Annual General Meeting, Nov 04, 2024 Botanix Pharmaceuticals Limited, Annual General Meeting, Nov 04, 2024. Location: at the offices of bdo, level 9, mia yellagonga tower 2, 5 spring street, perth, western australia. Australia Reported Earnings • Aug 31
Full year 2024 earnings: EPS exceeds analyst expectations while revenues lag behind Full year 2024 results: AU$0.009 loss per share (further deteriorated from AU$0.008 loss in FY 2023). Net loss: AU$13.9m (loss widened 52% from FY 2023). Revenue missed analyst estimates by 25%. Earnings per share (EPS) exceeded analyst estimates by 8.0%. Revenue is forecast to grow 108% p.a. on average during the next 2 years, compared to a 42% growth forecast for the Pharmaceuticals industry in Australia. Over the last 3 years on average, earnings per share has remained flat but the company’s share price has increased by 72% per year, which means it is well ahead of earnings. Announcement • Jun 28
Botanix Pharmaceuticals Limited has completed a Follow-on Equity Offering in the amount of AUD 70 million. Botanix Pharmaceuticals Limited has completed a Follow-on Equity Offering in the amount of AUD 70 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 233,333,334
Price\Range: AUD 0.3
Discount Per Security: AUD 0.015
Transaction Features: Subsequent Direct Listing New Risk • May 23
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$27m 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$27m free cash flow). Revenue is less than US$1m (AU$437k revenue, or US$290k). Minor Risk Shareholders have been diluted in the past year (20% increase in shares outstanding). New Risk • Feb 29
New minor risk - Financial position The company has less than a year of cash runway based on its current free cash flow. Free cash flow: -AU$27m This is considered a minor 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 Risk Revenue is less than US$1m (AU$460k revenue, or US$299k). Minor Risks Less than 1 year of cash runway based on current free cash flow (-AU$27m). Shareholders have been diluted in the past year (32% increase in shares outstanding). Announcement • Jan 30
Botanix Pharmaceuticals Limited, Annual General Meeting, Mar 01, 2024 Botanix Pharmaceuticals Limited, Annual General Meeting, Mar 01, 2024, at 10:00 W. Australia Standard Time. Location: BDO, Level 9, Mia Yellagonga Tower 2, 5 Spring Street Perth Western Australia Australia Agenda: To consider ratification of issue of Placement Shares to sophisticated and professional investors; to consider ratification of issue of Fee Options to Euroz Hartleys Limited (or its nominee(s)); and to discuss other matters. Announcement • Nov 29
Botanix Pharmaceuticals Limited has filed a Follow-on Equity Offering in the amount of AUD 13.5 million. Botanix Pharmaceuticals Limited has filed a Follow-on Equity Offering in the amount of AUD 13.5 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 103,846,154
Price\Range: AUD 0.13
Discount Per Security: AUD 0.0078
Transaction Features: Subsequent Direct Listing Reported Earnings • Oct 03
Full year 2023 earnings released: AU$0.008 loss per share (vs AU$0.014 loss in FY 2022) Full year 2023 results: AU$0.008 loss per share (improved from AU$0.014 loss in FY 2022). Revenue: AU$3.77m (up 37% from FY 2022). Net loss: AU$9.15m (loss narrowed 31% from FY 2022). Over the last 3 years on average, earnings per share has increased by 6% per year whereas the company’s share price has increased by 11% per year. Announcement • Aug 31
Botanix Pharmaceuticals Limited, Annual General Meeting, Nov 08, 2023 Botanix Pharmaceuticals Limited, Annual General Meeting, Nov 08, 2023, at 09:00 W. Australia Standard Time. Location: the offices of BDO, Level 9, Mia Yellagonga Tower 2, 5 Spring Street, Perth Western Australia Australia Agenda: To consider the re-election of directors. New Risk • Aug 31
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 Risk Less than 1 year of cash runway based on free cash flow trend (-AU$20m free cash flow). Minor Risks Latest financial reports are more than 6 months old (reported December 2022 fiscal period end). Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (45% increase in shares outstanding). Revenue is less than US$5m (AU$6.8m revenue, or US$4.4m). Announcement • Aug 25
Botanix Pharmaceuticals Limited Appoints Howie Mckibbon as Chief Executive Officer Botanix Pharmaceuticals Limited announced that Dr. Howie McKibbon has been appointed as Chief Executive Officer of the Company, following his promotion from Chief Operating Officer. No changes to the Board have been made as a result of this appointment and the appointment is effective 24 August 2023 (Arizona time). Dr. McKibbon was also previously the Chief Commercial Officer for Botanix, and this new promotion reflects both his extensive 25 year experience in the pharmaceutical industry, as well as his development under the guidance of Executive Chairman Vince Ippolito, at Botanix and previous successful dermatology companies, such as Dermavant Sciences, Anacor and Medicis. Dr. McKibbon is based in Phoenix, Arizona, where Botanix has recently expanded its commercial operations. Prior to his roles with Botanix, Dr. McKibbon held the role of Senior Vice-President, Worldwide Commercial Operations at Dermavant Science, where he transitioned Dermavant from a subsidiary, to a fully functioning independent dermatology company and was integral in the acquisition of the product. Before that as Senior Vice President, Sales & Marketing, he built the commercial organization, led the cross-functional launch teams and sat on the clinical development team at Anacor Pharmaceuticals, a dermatology-focused biopharmaceutical company acquired by Pfizer for USD 5.2 billion in 2016. Prior to Anacor, Dr. McKibbon was Vice-President, Dermatology and Immunology at Medicis Pharmaceuticals and helped grow Medicis to be the largest independent dermatology company in the world, when it was acquired by Bausch Health for USD 2.6 billion in 2012. His background also includes cross-functional leadership positions across portfolios of neuroscience and oncology brands, at Cephalon and Wyeth Pharmaceuticals. Over the course of his career, Dr. McKibbon has launched more than 15 branded products, managed over thirty dermatology products, and played a significant role in two of the largest dermatology acquisitions with combined valuations of USD 7.8 billion. He holds a B.A. in History from the University of South Florida, an MBA from Mercer University's Stetson School of Business and Economics, and a Doctor of Pharmacy from Mercer University's Southern School of Pharmacy. Announcement • Aug 18
Botanix Pharmaceuticals Limited, Annual General Meeting, Sep 18, 2023 Botanix Pharmaceuticals Limited, Annual General Meeting, Sep 18, 2023, at 09:00 W. Australia Standard Time. Location: offices of Gilbert + Tobin, Level 16, Brookfield Place Tower 2, 123 St Georges Terrace Perth Western Australia Australia Agenda: To consider ratification of issue of April Placement Shares to institutional and sophisticated investors; to ratify issue of July Placement Shares to institutional and sophisticated investors; and to ratify issue of Fee Options. New Risk • Aug 04
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 Less than 1 year of cash runway based on free cash flow trend (-AU$20m free cash flow). Minor Risks Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (45% increase in shares outstanding). Revenue is less than US$5m (AU$6.8m revenue, or US$4.5m). Announcement • Dec 08
Botanix Pharmaceuticals Limited Announces Confirmation Sofpironium Bromide Nda Formally Under Review Botanix Pharmaceuticals Limited advised that it has successfully received confirmation from FDA in writing that the Sofpironium Bromide New Drug Application (NDA) is now formally under review. FDA's communication confirmed that there were no filing review issues identified and that the NDA was sufficiently complete to permit substantive review. FDA also confirmed that they do not believe that an advisory committee meeting is required to discuss the application. Advisory committee meetings are sometimes convened by FDA to assist in FDA's review of complex applications, or where the opinion of independent experts or the public is viewed as important to the FDA decision making progress. With the formal filing of the Sofpironium Bromide NDA now accepted by FDA and a standard review period confirmed, a mid-cycle review remains on track for First Quarter 2023 which is an important next milestone for Botanix. The mid-cycle review provides FDA management and review teams with an opportunity to discuss the review status, key findings, timelines and any other issues relating to the NDA review which will be communicated to Botanix and will allow to align commercialization plans accordingly. Board Change • Nov 16
Less than half of directors are independent Following the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 4 non-independent directors. Independent Non-Executive Director Stewart Washer was the last independent director to join the board, commencing their role in 2019. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Announcement • Oct 21
Botanix Pharmaceuticals Limited Promotes Howie Mckibbon to Chief Operating Officer Botanix Pharmaceuticals Limited announced the promotion of Dr. Howie McKibbon to Chief Operating Officer, from his current position as Chief Commercial Officer. Mr. Vince Ippolito remains Executive Chairman along with executive directors Mr. Matt Callahan and Dr. Bill Bosch, and non-executive directors Mr. Danny Sharp and Dr. Stewart Washer make up the balance of the Board. Dr. McKibbon has more than 20 years of leadership experience in the pharmaceutical industry and has served as the Senior Vice-President, Worldwide Commercial Operations at Dermavant Science, where he was responsible for all Commercial activity and a played a major role in building the company and acquiring the psoriasis product VTAMA®. Prior to that, he was the Senior Vice President, Sales and Marketing at Anacor Pharmaceuticals and Vice-President, Dermatology and Immunology at Medicis Pharmaceuticals. Dr. McKibbon has launched more than 15 products and has played a significant role in two of the larger dermatology acquisitions in the industry, with combined valuations of $7.8 billion. He holds a B.A. in History from the University of South Florida, an MBA from Mercer University's Stetson School of Business and Economics and a Doctor of Pharmacy from Mercer University's Southern School of Pharmacy. Dr. McKibbon's promotion is accompanied by some other internal restructuring, which will see the Company's broader consultant team being reduced and refocused on supporting Sofprionium Bromide approval activities, as well as planning for the next stage of development of the Company's rosacea and acne clinical programs. Announcement • Oct 13
Botanix Pharmaceuticals Limited Announces Positive Data from its BTX 1702 Phase 1B/2 Papulopustular Rosacea Clinical Study Botanix Pharmaceuticals Limited announced positive data from its BTX 1702 Phase 1b/2 papulopustular rosacea clinical study ("the Study"). The BTX 1702 10% gel dose of the study achieved statistical significance in the FDA designated endpoint of reduction in inflammatory lesions (absolute reduction, p=0.02 and percentage reduction, p=0.03) and also approached statistical significance for the investigator's global assessment "IGA for papules and pustules" (grade of 0 or 1 at day 57, p=0.059 and 2 grade improvement from baseline, p=0.059). The BTX 1702 10% gel dose was also found to be very safe and well tolerated when compared to Permetrex vehicle (control) gel. The BTX 1702 20% dose was not superior to the 10% dose, but was safe and well tolerated and provides a significant safety margin for the target 10% dose. Efficacy of both the 10% and 20% BTX 1702 doses increased at each time point measured during the 8-week Study. The BTX 1702 Phase 1b/2 clinical study was a randomised, double blind, vehicle-controlled study in patients with moderate to severe papulopustular rosacea. The Study was designed to investigate the safety and tolerability of BTX 1702 in adults over an 8-week treatment period, with two different concentrations of BTX 1702 tested along with a vehicle (control) arm. The Study enrolled 133 patients in 16 dermatology clinical sites across Australia and New Zealand. Patients were randomised into 3 separate treatment groups consisting of BTX 1702 10% gel (n=45) applied twice daily, BTX 1702 20% gel (n = 45) applied twice daily and vehicle gel (control n= 43) applied twice daily. Patients aged 18 to 65 years old with moderate to severe papulopustular rosacea that met the relevant eligibility and inclusion criteria were enrolled in the Study with 84% of the patient population comprising females and 16% males. The primary endpoints for the Study were safety and tolerability. Additionally, several exploratory efficacy endpoints were evaluated, including: absolute reduction and percent change, from baseline in inflammatory lesions; the proportion of patients achieving at least clear or almost clear, and a 2- grade improvement from baseline on the 5-grade Investigator's Global Assessment (IGA) scale and the change in the Clinician's Erythema Assessment (CEA) scale. Endpoints were assessed at baseline and completion of the 8-week treatment period (day 57) and for some endpoints, also at days 15 and 29 of the Study. Study results There were no serious adverse events observed during the Study and all arms (vehicle gel, 10% and 20% BTX 1702 gel) were safe and well tolerated. There were no serious adverse events and most adverse events that did occur, were localised and mild in nature. Patients enrolled in the 10% BTX 1702 arm experienced no burning and stinging, while patients enrolled in the vehicle and 20% BTX 1702 arms experienced some minor burning and stinging (less than 5%). For the exploratory efficacy endpoints, both doses of BTX 1702 showed clinically positive results, with the 10% showing greater results, being statistically significant compared to vehicle, for reductions in inflammatory lesion counts and improvement in investigator's global assessment (IGA) endpoints. As outlined in the attached presentation, improvements were seen at each time point measured in the Study of the efficacy endpoints. Based on the results from the Study, the Company believes that the 10% BTX 1702 dose is the superior formulation with the most attractive safety and efficacy profile to take into further clinical development and has the potential to be the best-in-class treatment for papulopustular rosacea. The higher 20% BTX 1702 dose produced some safety and tolerability issues not seen in the 10% dose and the efficacy observed was not superior to the 10% BTX 1702 dose. Available data from competitive products that have published efficacy outcomes after 8 weeks of treatment, suggests that 10% BTX 1702 is comparable in lesion reduction and IGA improvement at the same point in time, with a possible improvement in safety and tolerability. Separately, the reduction in redness, as measured by the CEA outcome compares very favourably with products designed to reduce redness. Announcement • Sep 26
Botanix Pharmaceuticals Limited Submits FDA New Drug Application for Sofpironium Bromide Botanix Pharmaceuticals Limited announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of Sofpironium Bromide for patients with severe primary axillary hyperhidrosis. The submission follows the successful results from the Cardigan (Phase 3 clinical trials), which demonstrated highly statistically significant clinical efficacy and excellent safety. Sofpironium Bromide is a topically applied gel which has successfully completed Phase 3 studies with very high statistical significance for the treatment of primary axillary hyperhidrosis (a medical condition which causes excessive underarm sweating). Positive results from the Phase 3 Cardigan I and II clinical studies demonstrated very high statistical significance on both co-primary and all key secondary endpoints. More than 700 patients were enrolled in the two Phase 3 studies and approximately 300 patients participated in a separate 48-week safety study of Sofpironium Bromide. There were no treatment related serious adverse events in any of the studies and adverse events were transient and mild to moderate in nature. Based on these studies, the Company believes that Sofpironium Bromide has the potential to be the best-in-class treatment for axillary hyperhidrosis. In the US alone, there are approximately 7.3 million subjects who suffer from severe primary axillary hyperhidrosis, which is the patient population in which the successful Phase 3 studies were conducted. Of those subjects, approximately 3.7 million subjects are actively seeking treatment. With the FDA filing of the Sofpironium Bromide NDA, Botanix is accelerating its transition to a commercial dermatology company that can be revenue generating following FDA approval, which is expected to be received 12 months after filing. Botanix has begun building its commercial capability and will be preparing for the important mid-cycle review from FDA which occurs 6 months after filing of the NDA. The Company will continue to look for other opportunities to bolster its pipeline with additional late stage or revenue producing dermatology products, that can be acquired for modest cost and which contribute to profitability and value. Announcement • Sep 12
Botanix Pharmaceuticals Limited, Annual General Meeting, Nov 03, 2022 Botanix Pharmaceuticals Limited, Annual General Meeting, Nov 03, 2022. Agenda: to consider re-election of directors. Reported Earnings • Sep 02
Full year 2022 earnings released: AU$0.013 loss per share (vs AU$0.003 loss in FY 2021) Full year 2022 results: AU$0.013 loss per share (down from AU$0.003 loss in FY 2021). Revenue: AU$2.75m (down 60% from FY 2021). Net loss: AU$13.2m (loss widened 295% from FY 2021). 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 31% per year, which means it is significantly lagging earnings. Recent Insider Transactions Derivative • Jul 10
MD, President & Executive Chairman exercised options to buy AU$370k worth of stock. On the 7th of July, Vincent Ippolito exercised options to buy 5m shares at a strike price of around AU$0.055, costing a total of AU$291k. As of today, Vincent currently holds no shares directly. Company insiders have collectively bought AU$327k more than they sold, via options and on-market transactions, in the last 12 months. Board Change • Apr 27
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. 4 non-independent directors. Independent Non-Executive Director Stewart Washer was the last independent director to join the board, commencing their role in 2019. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Announcement • Apr 01
Botanix Pharmaceuticals Limited Appoints Howie Mckibbon as Chief Commercial Officer and Patricia Walker as Chief Medical Adviser Botanix Pharmaceuticals Limited announced that experienced dermatology executives Howie McKibbon and Dr Patricia Walker have joined Botanix. Mr. McKibbon joins as Chief Commercial Officer and Dr Walker joins as Chief Medical Adviser.Howie has more than 20 years of leadership experience in the pharmaceutical industry and mostrecently served as the Senior Vice-President, Worldwide Commercial Operations at DermavantScience, where he was responsible for all Commercial activity and played a major role in building thecompany and acquiring the flagship psoriasis product tapinarof.Dr Walker is a board-certified dermatologist specializing in medical and aesthetic dermatology. She isan industry expert and has served in various leadership roles, including President and head of R&D forBrickell Biotech, Chief Medical Officer for Kythera Biopharmaceuticals Inc., Executive Vice Presidentand Chief Scientific Officer for Allergan Medical Aesthetics and Vice President and DermatologyTherapeutic Area Head at Allergan. Reported Earnings • Feb 24
First half 2022 earnings: EPS in line with analyst expectations despite revenue beat First half 2022 results: AU$0.007 loss per share (down from AU$0.001 profit in 1H 2021). Net loss: AU$6.51m (down AU$7.17m from profit in 1H 2021). Revenue exceeded analyst estimates by 1.9%. Earnings per share (EPS) were mostly in line with analyst estimates. Over the last 3 years on average, earnings per share has increased by 42% per year but the company’s share price has fallen by 22% per year, which means it is significantly lagging earnings. Announcement • Oct 01
Botanix Pharmaceuticals Limited Announces Launch of Canine Atopic Dermatitis Program Botanix Pharmaceuticals Limited provided a development update on its BTX 1204A study in canines with atopic dermatitis, as well as a general update on its dermatology focused clinical and business development activities. BTX 1204A canine study now underway: Botanix announced its BTX 1204A POC study in canines with atopic dermatitis is now underway with receipt of ethics approval and initiation of sites in Australia and New Zealand. The updated study design now plans to enrol 45 canines across 3 dermatology sites which will evaluate two formulations of BTX 1204A (high dose and low dose) and a vehicle arm (15 dogs each). Each subject will be treated twice daily with topically applied BTX 1204A over a 28-day period. The study objective will be to evaluate treatment effectiveness, using the Enhanced Pruritus Score (EPS) and Canine Atopic Dermatitis Extent and Severity Index (CADESI-04). Atopic dermatitis in canines and humans is clinically and immunologically very similar. Successful outcomes from the BTX 1204A POC study will drive licensing programs for animal health and also support progression to a late-stage Phase 2b clinical study in humans with atopic dermatitis. The potential benefit of BTX 1204A in canine and human atopic dermatitis is supported by studies that indicate synthetic CBD addresses multiple factors of disease pathology, inhibits itch and repairs skin barrier dysfunction, is a potent antimicrobial against Staph Aureus bacteria, and has broad anti-inflammatory properties. There is significant unmet need for an effective, safe and topically applied therapeutic to treat atopic dermatitis. In the US alone, approximately 31 million people have a form of the disease, with 1 in 10 people in the general population developing symptoms during their lifetime. BTX 1702 rosacea study progressing well: Botanix advised that recruitment for its BTX 1702 Phase 1b rosacea study is progressing to plan, despite COVID-19 restrictions in some of the areas where clinic sites have been selected. Recruitment for clinical studies is considered "essential work" under the respective States' guidelines and additional sites have been screened to maintain recruitment momentum if required in future. The BTX 1702 Phase 1b rosacea study is a randomised, double blind, vehicle-controlled study in patients with moderate to severe papulopustular rosacea. The study is investigating the safety and tolerability of two different concentrations of BTX 1702 and a vehicle (placebo) arm in adults, over an 8-week treatment period. The study plans to enrol approximately 120 patients in dermatology clinical sites across Australia and New Zealand. Reported Earnings • Aug 27
Full year 2021 earnings released: AU$0.003 loss per share (vs AU$0.018 loss in FY 2020) The company reported a decent full year result with reduced losses and improved control over expenses, although revenues were weaker. Full year 2021 results: Revenue: AU$6.99m (down 7.6% from FY 2020). Net loss: AU$3.33m (loss narrowed 80% from FY 2020). Over the last 3 years on average, earnings per share has increased by 35% per year but the company’s share price has fallen by 11% per year, which means it is significantly lagging earnings. Announcement • May 17
Botanix Pharmaceuticals Limited Announces Results from BTX 1204A Pilot Study Botanix Pharmaceuticals Limited announced the results from a small pilot study of BTX 1204A in canines with atopic dermatitis (`the BTX 1204A Pilot Study'). The BTX 1204A Pilot Study was conducted in canines with atopic dermatitis which were treated topically with BTX 1204A over a 28-day period. The study objective was to evaluate treatment effectiveness, using the Enhanced Pruritus Score (ESP) and Canine Atopic Dermatitis Extent and Severity Index (CADESI-04). BTX 1204A is based on a new higher dose formulation of synthetic cannabidiol (CBD) in a novel PermetrexTM formulation. This new formulation was utilised in the recent successful BTX 1801 Phase 2a study, which showed excellent efficacy in killing bacteria and separation between drug active and vehicle arms. Effectiveness of the BTX 1204A treatment was evaluated at Day 0, Day 14 and Day 28 (for ESP) and Day 0 and Day 28 (for CADESI-04). The study was conducted in 4 dogs in Australia who were screened for moderate to severe dermatitis with visible lesions. Data generated in the BTX 1204A Pilot Study, undertaken by Botanix, demonstrated that a new higher dose formulation of synthetic CBD showed significant reductions on average in both the ESP and CADESI-04 scores over the 28-day treatment period. BTX 1204A showed a decrease in pruritus over a 28-day treatment period, resulting in an average pruritus rating on the Enhanced Pruritus Score (ESP) system of Very Mild post-treatment (from pre-treatment rating of Moderate). In addition, BTX 1204A had a positive effect and showed a decrease in pruritus over a 28-day treatment period, resulting in a 57.3% reduction from baseline in the Canine Atopic Dermatitis Extent and Severity Index (CADESI-04) scale. The results achieved in the BTX 1204A Pilot Study are encouraging and given the limited subjects enrolled, supports further exploration and investigation of the atopic dermatitis indication. Atopic dermatitis is the chronic inflammation of the skin resulting in itchy, red, swollen and cracked skin. Symptoms of the disease are made worse by scratching the affected area, and those affected have an increased risk of skin infections. The potential benefit of BTX 1204A in canines and humans is supported by studies that indicate synthetic CBD addresses multiple factors of disease pathology, inhibits itch and repairs skin barrier dysfunction, is a potent antimicrobial against Staph Aureus bacteria vi and broad anti-inflammatory properties. A significant unmet need remains for a safe, topically applied therapeutic to treat atopic dermatitis. In the US, 31.6 million people have a form of the disease with 1 in 10 people developing symptoms during their lifetime. While a relatively small study, the results of the BTX 1204 Pilot Study are encouraging and warrant expansion of the program into a larger proof of concept canine study planned to commence in second quarter of 2021. Successful outcomes from this larger BTX 1204A proof of concept canine study will support both partnering opportunities for the animal health application of the product and also progression of BTX 1204A into a Phase 2b clinical study in humans with atopic dermatitis which could commence as early as second quarter of 2022. Reported Earnings • Mar 03
First half 2021 earnings released: EPS AU$0.001 (vs AU$0.008 loss in 1H 2020) The company reported a decent first half result with improved earnings and profit margins, although revenues were weaker. First half 2021 results: Revenue: AU$6.89m (down 8.9% from 1H 2020). Net income: AU$664.1k (up AU$7.66m from 1H 2020). Profit margin: 9.6% (up from net loss in 1H 2020). The move to profitability was driven by lower expenses. Over the last 3 years on average, earnings per share has increased by 6% per year whereas the company’s share price has increased by 1% per year. Announcement • Mar 01
Botanix Pharmaceuticals Limited Expands Management Team Botanix Pharmaceuticals Limited (Botanix or the Company) announced the expansion of its management team with three new key hires in the US to drive its antimicrobial and dermatology programs. Dr. Clarence Young joins Botanix as Chief Medical Officer, Anthony Robinson joins as Vice President of Development and Lynda Berne joins as Head of Commercial. Dr. Young was recently Chief Medical Officer at Velicept Therapeutics and Senior Vice-President and Chief Medical Officer at Iroko Pharmaceuticals, where he provided clinical and medical leadership for three NDA filings and approvals. He also has held executive leadership positions for Novartis and one of its acquisitions, Protez Pharmaceuticals, where he served as Vice President, Drug Development and Chief Medical Officer. Dr. Young began his pharmaceutical career at GlaxoSmithKline, where he was Vice President and Global Head, Anti-Infectives Clinical Development. Dr. Young is a Fellow of the Infectious Diseases Society of America and served on the White House Working Group on Antimicrobial Resistance. He is a graduate of Williams College and Harvard Medical School and the author of numerous peer reviewed articles, reviews and scientific presentations. Anthony Robinson was recently Vice President, Head of Clinical Operations, Program Management and Regulatory Affairs at Advicenne and previously held similar positions at Aquestive Therapeutics and Intrommune Therapeutics, and developed extensive expertise in drug development, clinical operations and regulatory affairs at Shire Pharmaceuticals (acquired by Takeda) and global contract research organisation, Covance. Anthony holds multiple qualifications including an MBA from Penn State University, a Master of Science from Drexel University and a Bachelor of Science from Cornell University. Announcement • Feb 03
Botanix Pharmaceuticals Limited Announces Positive Top-Line Data from BTX 1801 Phase 2A Nasal Decolonisation Proof of Concept Study Botanix Pharmaceuticals Limited announced positive top-line data from its BTX 1801 Phase 2a nasal decolonisation proof of concept study ("1801 Study"). The top-line data shows that two different BTX 1801 formulations (ointment and gel) were safe, well tolerated and successful at eradicating Staphylococcus aureus ("Staph") bacteria from the nose of healthy participants nasally colonised 1 with Staph. Summary of 1801 Study design and endpoints: The 1801 Study was a randomised, vehicle-controlled, double-blind, Phase 2a study conducted at a single site due to constraints associated with COVID-19. The primary objectives focused on evaluating safety and tolerability, as well as evaluating the effectiveness of two different candidate formulations of BTX 1801 (ointment or gel containing synthetic cannabidiol), compared to their respective vehicle or placebo formulations (the ointment or gel without synthetic cannabidiol). Each formulation was applied twice daily for 5 consecutive days to the anterior nares (the inner surface of the nose) of healthy participants intranasally colonised with Staph. Male and female healthy volunteers aged 18- 65 were eligible to enroll in the 1801 Study. Safety and tolerability were evaluated at prespecified timepoints during treatment (Days 1 to 5) and following treatment at Day 7 (2 days after the end of treatment), Day 12 (7 days following the end of treatment) and at Day 28 (23 days after the end of treatment). Efficacy was evaluated at Day 7, Day 12 and Day 28. No prospective calculations of statistical power were made for this exploratory study. Summary of 1801 Study results: Results of the BTX 1801 Study show the two formulations of BTX 1801 met the Study endpoints. Firstly, BTX 1801 was safe and well tolerated, with all 66 enrolled participants successfully completing the 1801 Study with each group (ointment, gel and vehicle) consisting of 22 participants. The incidence of adverse events was low, mild in severity and occurred at similar rates across the different treatment groups with no severe events reported. Secondly, efficacy of both ointment and gel formulations at the primary endpoint of Day 12 was demonstrated. At Day 7, one of the secondary endpoints (2 days after the end of the treatment period), Staph eradication was demonstrated in 76.2% and 68.8% of the participants in the BTX 1801 ointment and gel groups respectively, compared with 27.8% of participants in the combined vehicle groups. At Day 12 (7 days after the end of the treatment period), the primary endpoint, BTX 1801 demonstrated Staph eradication in 38.1% of participants in the ointment group and 25.0% in the gel group, compared to 16.7% for the combined vehicle groups. Despite no treatment since Day 5 of the study, by Day 28, the other secondary endpoint, (23 days after the end of the treatment period), Staph eradication rates of both formulations of BTX 1801 only declined slightly from Day 12, to 23.8% and 18.8% for the BTX 1801 ointment and gel groups respectively, compared with 12.5% for participants in the combined vehicle groups. Announcement • Jan 22
Botanix Pharmaceuticals Limited Publishes Antimicrobial Data in Peer-Reviewed Research Journal Botanix Pharmaceuticals Limited announced the publication of research data from its antimicrobial platform in Nature Research's peer-reviewed journal, Communications Biology. The research article entitled "The antimicrobial potential of cannabidiol" has been released via open access. The lead author is Dr Mark Blaskovich, Director of the University of Queensland's Centre for Superbug Solutions in the Institute for Molecular Science and Botanix Directors Matt Callahan and Dr Michael Thurn are co-authors. The research represents the culmination of research collaborations involving leading antimicrobial researchers across the world and all research data generated is fully-owned by Botanix and is the subject of several patent applications. The research article provides detailed descriptions of the antimicrobial activity of cannabidiol, some of which has recently been released by the Company 2 and separately presented by Dr Mark Blaskovich at international antimicrobial congresses on the Company's behalf. Importantly, the research article details for the first-time that cannabidiol can selectively kill a subset of Gram-negative bacteria that includes the `urgent threat' pathogen Neisseria gonorrhoeae which causes gonorrhea, as well as the bacteria that cause meningitis and legionnaires disease. N. gonorrhoeae for example, is a key pathogen on both World Health Organization and Centers for Disease Control and Prevention lists and is responsible for sexually transmitted gonorrhea, which is the second most commonly reported notifiable disease in the United States, with almost 1 million new infections each year in the US alone (~550k drug-resistant), and an estimated 78m cases globally. The article also describes Botanix's foundational work for generating novel synthetic analogs of cannabinoids and their tested antimicrobial activity. The results illustrate the potential to advance these analogs as a much-needed new class of antimicrobials to fight the growing global threat of resistance to antibiotics. Notably, design variations tested by Botanix, show that there is potential to develop targeting agents that are not only selective for particular target Gram-positive and Gram-negative bacteria, but also spare the natural microbiome by not killing beneficial bacteria on the skin, in the digestive tract or throughout the body. This could potentially provide a significant advantage to novel synthetic cannabinoids over other classes of antimicrobial compounds currently approved or in development. BTX 1801 Phase 2a antimicrobial study is completed and awaiting data Botanix is also pleased to confirm that the Company's BTX 1801 antimicrobial clinical study is completed and on track to announce data in early first Quarter of calendar year 2021. The study aims to test the ability of the nasally applied BTX 1801 ointment to eradicate Staphylococcus aureus (Staph) and methicillin-resistant Staphylococcus aureus (MRSA) from the nose of individuals known to carry these bacteria in their nasal cavity. Nasal "carriage" of Staph and/or MRSA greatly increases the risks of serious and sometimes life-threatening infections following surgery, as patients essentially infect themselves. Nasal decolonisation is a commonly used method for preventing SSIs, but overuse of the widely available antibiotic BactrobanTM (also known as mupirocin) has led to a significant increase in the development of bacterial resistance to antibiotics. The double-blind, vehicle controlled BTX 1801 Phase 2a clinical study has been designed to evaluate the safety and local tolerability of two formulations of BTX 1801 to decolonise Staph and MRSA (or `Golden Staph') from the nose of healthy adults. Announcement • Dec 15
Botanix Pharmaceuticals Limited Provides Update on BTX 1801 Phase 2A Clinical Study Botanix Pharmaceuticals Limited announced that all participants have successfully completed the BTX 1801 antimicrobial Phase 2a clinical study. Finalisation of data collection is now underway to support database lock, data analysis and generation of top-line data very early in First Quarter CY2021. In April this year Botanix announced that the United States Food and Drug Administration Office of Antimicrobial Products had granted BTX 1801 Qualified Infectious Disease Product (QIDP) status for the prevention of post-surgical infections. The BTX 1801 Phase 2a clinical study was designed to test the ability of 2 different formulations of BTX 1801 to eradicate or `decolonise' nasal carriage of Staphylococcus aureus (Staph) and methicillin-resistant Staphylococcus aureus (MRSA) from the nasal cavity of healthy participants. Remarkably, 80% of all post-surgical infections are caused by the patient infecting themselves through spreading Staph and MRSA resident in their own nasal cavity. Research has shown that worldwide 1 in 3 people carry Staph and/or MRSA in their nose. Nasal decolonisation is a commonly used method for preventing SSIs, but overuse of the widely available antibiotic BactrobanTM (mupirocin) has led to significant increase in the development of bacterial resistance to antibiotics. In November 2020, Botanix successful completed a Pre-Investigational New Drug (Pre-IND) meeting with the FDA for its BTX 1801 synthetic CBD antimicrobial product. The Pre-IND meeting provided Botanix an opportunity to seek advice and clarification from the FDA on the development plan and data package required to initiate clinical studies for BTX 1801 in the US. It also enabled Botanix to gain feedback from the FDA on the drug development plan required for BTX 1801 to support a Fast-Track designation and New Drug Application in light of its existing Qualified Infectious Disease Product designation. Announcement • Sep 21
Botanix Pharmaceuticals Limited(ASX:BOT) dropped from S&P/ASX Emerging Companies Index Botanix Pharmaceuticals Limited(ASX:BOT) dropped from S&P/ASX Emerging Companies Index 
