New Risk • Aug 27
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended December 2022. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (80% average weekly change). Earnings are forecast to decline by an average of 36% per year for the foreseeable future. Market cap is less than US$10m (€8.72m market cap, or US$9.42m). Minor Risks Latest financial reports are more than 6 months old (reported December 2022 fiscal period end). Currently unprofitable and not forecast to become profitable over next 2 years (AU$49m net loss in 2 years). Shareholders have been diluted in the past year (8.5% increase in shares outstanding). Revenue is less than US$5m (AU$6.0m revenue, or US$3.9m). お知らせ • Aug 24
Bionomics Completes Last Patient Last Visit in the Phase 2B Attune Study for Post-Traumatic Stress Disorder Bionomics Limited announced that the last patient last visit has been completed in its Phase 2 ATTUNE study in PTSD, and disclosed timing of the End of Phase 2 (EoPh2) meeting to review advancing BNC210 into Phase 3 program in patients with SAD. The Phase 2b ATTUNE study (NCT04951076) is a double-blind, placebo-controlled, randomized study of twice daily BNC210 as monotherapy treatment for PTSD. The primary endpoint is change in a Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total symptom severity scores from baseline to week 12 compared to placebo. Secondary endpoints include change from baseline to week 12 compared to placebo on the PTSD-checklist (PCL-5), anxiety (Hamilton Anxiety Rating Scale, HAM-A), depression (Montgomery-Asberg Depression Rating Scale, MADRS), Clinician Global Impression (CGI), Patient Global Impression (PGI), sleep (Insomnia Severity Index, ISI) and disability (Sheehan Disability Scale, SDS) scales. Approximately 200 participants have been enrolled at 27 sites in the United States and 7 sites in the United Kingdom, and topline results are anticipated by the end of September 2023. The EoPh2 meeting to discuss advancing BNC210 into Phase 3 development as an acute treatment for SAD has been scheduled for mid-September 2023. At this meeting, Bionomics will discuss with the FDA its plans for a Phase 3 program that would support the submission of a new drug application for BNC210 for the treatment of SAD. The Company believes that the results from Phase 2 PREVAIL study support the progression of BNC210 into Phase 3 and plans to provide an update by the end of 2023 following the receipt of formal meeting minutes from the FDA. New Risk • Aug 01
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: €8.85m (US$9.71m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (72% average weekly change). Earnings are forecast to decline by an average of 36% per year for the foreseeable future. Market cap is less than US$10m (€8.85m market cap, or US$9.71m). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (AU$49m net loss in 2 years). Shareholders have been diluted in the past year (8.5% increase in shares outstanding). Revenue is less than US$5m (AU$6.0m revenue, or US$4.0m). Reported Earnings • Feb 24
First half 2023 earnings released: AU$0.012 loss per share (vs AU$0.013 loss in 1H 2022) First half 2023 results: AU$0.012 loss per share. Net loss: AU$16.2m (loss widened 24% from 1H 2022). Revenue is forecast to grow 6.9% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in Europe. Board Change • Feb 01
High number of new directors There are 5 new directors who have joined the board in the last 3 years. CEO, President & Director Spyros Papapetropoulos was the last director to join the board, commencing their role in 2023. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model.