New Risk • Aug 26
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 (24% 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 (AU$14.7m 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). Aankondiging • 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 02
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: AU$14.7m (US$9.67m) 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 (20% 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 (AU$14.7m market cap, or US$9.67m). 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 11% growth forecast for the Biotechs industry in Australia. 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. Aankondiging • Dec 19
Bionomics Limited Reports Results in PREVAIL Phase2 Study BNC210 Bionomics Limited announced results from its Phase 2 randomised, double-blind, placebo-controlled, multi-centre, dose-ranging PREVAIL study to evaluate the safety, tolerability, and efficacy of BNC210 for the acute treatment of Social Anxiety Disorder (SAD). BNC210 has a novel mechanism of action that involves negative allosteric modulation of the 7 nicotinic acetylcholine receptor. While the primary endpoint as measured by the change from baseline to the average of the Subjective Units of Distress Scale (SUDS) scores during a 5-minute Public Speaking Challenge was not met in the BNC210-treated patients when compared to placebo, the findings do indicate a consistent trend toward improvements across primary and secondary endpoints and a favourable safety and tolerability profile consistent with previously reported results. The Company is continuing analysis of the PREVAIL dataset and is assessing next steps for the development of BNC210 in SAD. Board Change • Nov 16
High number of new and inexperienced directors There are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. 6 experienced directors. 1 highly experienced director. Executive Chairman Errol B. De Souza is the most experienced director on the board, commencing their role in 2008. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Aankondiging • Oct 14
Bionomics Limited, Annual General Meeting, Nov 16, 2022 Bionomics Limited, Annual General Meeting, Nov 16, 2022, at 09:30 Cen. Australia Standard Time. Location: Banquet Room, Adelaide Festival Centre King William Road. Adelaide SA 5000 Adelaide Australia Agenda: To receive and consider the Financial Report of the Company and the Directors' Report (including the Remuneration Report) and Auditor's Report as set out in the Company's Annual Report for the financial year ended 30 June 2022; to Adopt Remuneration Report; to consider board changes; and to consider other matters. Reported Earnings • Aug 26
Full year 2022 earnings: EPS and revenues exceed analyst expectations Full year 2022 results: AU$0.02 loss per share (down from AU$0.011 loss in FY 2021). Net loss: AU$21.8m (loss widened 150% from FY 2021). Revenue exceeded analyst estimates by 660%. Earnings per share (EPS) also surpassed analyst estimates by 99%. Over the next year, revenue is forecast to grow 58%, compared to a 33% growth forecast for the Biotechs industry in Australia. Over the last 3 years on average, earnings per share has fallen by 11% per year but the company’s share price has increased by 13% per year, which means it is well ahead of earnings. Board Change • Apr 27
High number of new and inexperienced directors There are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. 6 experienced directors. 1 highly experienced director. Executive Chairman Errol B. De Souza is the most experienced director on the board, commencing their role in 2008. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Board Change • Jan 07
High number of new and inexperienced directors There are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. 6 experienced directors. 1 highly experienced director. Executive Chairman Errol B. De Souza is the most experienced director on the board, commencing their role in 2008. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Aankondiging • Jan 06
Bionomics Limited announced that it has received $2.794495 million in funding Bionomics Limited announced that it has issued 43,794,000 shares at a price of $0.06381 for gross proceeds of $2,794,495 on January 5, 2022. Aankondiging • Jan 04
Bionomics Initiates Phase 2 Prevail Study of Bnc210 for the Acute Treatment of Social Anxiety Disorder Bionomics Limited announced that it has initiated its Phase 2 clinical trial (the PREVAIL Study) to evaluate BNC210 for the acute treatment of Social Anxiety Disorder (SAD), with topline results expected by the end of 2022. BNC210 is an oral, proprietary, selective negative allosteric modulator of the a7 nicotinic acetylcholine receptor in development for the acute treatment of SAD and chronic treatment of Post-Traumatic Stress Disorder (PTSD), with U.S. Food and Drug Administration (FDA) Fast Track designation for both clinical indications. The PREVAIL Study SAD protocol was cleared by the FDA in November 2021, and it was granted ethics approval by a central U.S. Institutional Review Board (IRB) in December 2021. With these approvals in place, as well as site-level approvals, clinical sites in the U.S. are now activated and open to screening for potential study participants aged 18 to 65 years old with marked to severe SAD. Study participants will need to have a score of at least 70 on the Liebowitz Social Anxiety Scale, which is a scale that assesses a patient's reported level of social phobia in a range of social and performance situations. It is anticipated that 15 to 20 clinical sites in the U.S. will be involved in recruiting patients for this study. In this randomised, double-blind, placebo-controlled trial, BNC210 will be evaluated as an acute, or single-dose, treatment for patients with SAD. Study participants will be randomly assigned to one of three treatment groups, 225 mg BNC210, 675 mg BNC210 or placebo, with approximately 50 participants in each group. They will be orally administered a single dose of their assigned treatment approximately one hour prior to taking part in an anxiety-provoking behavioral task involving a speaking challenge. The primary objective of the study is to compare each dose level of BNC210 to placebo on self-reported anxiety levels using the Subjective Units of Distress Scale (SUDS). Secondary objectives include two other scales measuring participants' anxiety levels (State-Trait Anxiety Inventory and Self-Statements During Public Speaking), as well as an evaluation of the safety and tolerability of BNC210 in this population. Board Change • Dec 31
High number of new directors Member of Clinical Advisory Board Srini Rao was the last director to join the board, commencing their role in 2021. Aankondiging • Dec 03
U.S. Food and Drug Administration Grants Bionomics Fast Track Designation to Bnc210 for the Acute Treatment of Social Anxiety Disorder and Other Anxiety Related Disorders Bionomics Limited announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the BNC210 development program for the acute treatment of Social Anxiety Disorder (SAD) and other anxiety-related disorders. In November 2019, the FDA granted Fast Track designation to the BNC210 development program for the treatment of Post-Traumatic Stress Disorder (PTSD) and other trauma-related and stressor-related disorders. Fast Track designation is a FDA program intended to facilitate and expedite development and review of new drugs that demonstrate the potential to address unmet medical need in the treatment of a serious or life-threatening disease or condition. A drug that receives Fast Track designation is eligible for some, or all, of the following: more frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval; more frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers; eligibility for priority review and accelerated approval, if relevant criteria are met; and possible review of the New Drug Application (NDA) on a rolling basis. NDA review usually does not begin until a company has submitted the entire drug application to the FDA. When an NDA is eligible for rolling review, FDA begins reviewing completed sections of an NDA before the entire NDA is submitted. BNC210 is an oral proprietary selective negative allosteric modulator of the 7 nicotinic acetylcholine receptor in development for the acute treatment of SAD and chronic treatment of PTSD. Following encouraging results in a previous Phase 2a study in Generalised Anxiety Disorder (GAD) patients where a single oral dose administration of BNC210 showed significantly reduced threat-avoidance behaviour and significantly reduced connectivity between the amygdala and the anterior cingulate cortex, a network involved in regulating anxious responses to aversive stimuli, BNC210 will be evaluated as an acute, or single-dose, treatment for patients with SAD in a planned Phase 2 clinical trial named the PREVAIL Study that we expect to initiate by the end of 2021. Aankondiging • Sep 21
Bionomics Prepares BNC210 for Start of Phase 2 Acute Treatment of Social Anxiety Disorder Trial Bionomics Limited announced that as part of its broader pipeline expansion strategy and based on anti-anxiety signals in Generalised Anxiety Disorder (GAD) patients, it has decided to proceed with evaluating its lead clinical compound, BNC210, for acute treatment of Social Anxiety Disorder (SAD) with a planned commencement of a clinical trial by the end of this year. BNC210 is an oral proprietary selective negative allosteric modulator of the a7 nicotinic acetylcholine receptor in development for the treatment of anxiety and trauma- and stressor-related disorders. A previous in-clinic Phase 2a study in GAD patients demonstrated that single dose administration of the liquid suspension formulation of BNC210 showed significant anti-anxiety signals as measured in brain imaging and behavioural studies, but without evidence of sedation or addictive potential. However, the slow absorption of the liquid suspension formulation of BNC210 and the requirement for it to be taken with food for optimal absorption, would limit its use in "real world" situations for the acute treatment of anxiety. A new solid dose tablet formulation of BNC210 has been developed showing much improved and rapid absorption and plan to use the tablet formulation for the Phase 2 acute treatment clinical trial in SAD patients. The Phase 2 SAD trial protocol has been developed with input from Bionomics' Clinical Advisory Board members and will compare BNC210 to placebo on anxiety levels using the Subjective Units of Distress Scale (SUDS) during an anxiety-provoking behavioural task following a single dose treatment with the study drug. Drug product has already been manufactured and study start-up activities are underway. It is anticipated that approximately 15 sites in the U.S. will be involved in the trial, recruiting approximately 150 patients suffering with SAD. Reported Earnings • Aug 26
Full year 2021 earnings released: AU$0.01 loss per share (vs AU$0.011 loss in FY 2020) Full year 2021 results: Net loss: AU$8.70m (loss widened 50% from FY 2020). Over the last 3 years on average, earnings per share has increased by 80% per year but the company’s share price has fallen by 27% per year, which means it is significantly lagging earnings. Aankondiging • Jul 06
Bionomics Initiates Phase 2B ATTUNE Study of BNC210 in PTSD Bionomics Limited announced that it has initiated a Phase 2b trial (the ATTUNE Study) to evaluate the tablet formulation of BNC210 in patients with Post-Traumatic Stress Disorder (PTSD) with top line results expected in 1H 2023. BNC210 is a novel, first-in-class, negative allosteric modulator of the 7 nicotinic acetylcholine receptor in development for the treatment of anxiety and stressor-related disorders and has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of PTSD and other trauma- and stressor-related disorders, recognising the high unmet medical need in the treatment of such serious conditions. The ATTUNE Study is a randomised, double-blind, placebo-controlled, multi-centre Phase 2b clinical trial with a 12-week treatment period. The primary objective is to compare BNC210 to placebo on the improvement in PTSD symptom severity as measured by the Clinician Administered PTSD scale for DSM-5 (CAPS-5) following 12 weeks of treatment. In addition to the clinician evaluation of PTSD symptom severity, there are a number of secondary objectives to measure patient-reported symptoms of PTSD, changes in anxiety and depression symptoms, and global and social functioning in the study participants. An oral tablet formulation of BNC210, showing much improved absorption over the previous liquid suspension formulation, will be evaluated in this study. The dose of BNC210 (900 mg twice daily) was selected based on achieving exposure levels that are predicted from a pharmacometric blood exposure-CAPS-5 response model, built on a previous BNC210 trial data set (RESTORE), as necessary to meet the primary endpoints for effectiveness for treating PTSD patients in clinical trials. Premier Research, Global Contract Research Organisation (CRO) headquartered in the U.S., is contracted to manage the ATTUNE Study which will be conducted at around 25 clinical sites in the U.S., recruiting approximately 200 patients with PTSD. Premier Research is recognized as a leading CRO supporting industry-sponsored PTSD studies. Dr. Frank Weathers, author of the CAPS-5, is delivering a comprehensive training program to clinical site raters in the use of the CAPS-5 assessment scale ensuring collection of robust and reliable study data for the primary endpoint measure. The trial protocol was submitted to the U.S. FDA at the end of May 2021 and on 22 June 2021 was granted ethics approval by a central human ethics Institutional Review Board (IRB). Clinical sites are activated and open to screen for potential study participants. Aankondiging • May 11
Bionomics BNC210 Expansion into Social Anxiety Disorder Bionomics Limited announced that as part of its broader pipeline expansion strategy and based on anti-anxiety efficacy signals in Generalised Anxiety Disorder (GAD) patients, it has decided to proceed with evaluating its lead clinical compound, BNC210, for acute treatment of Social Anxiety Disorder (SAD) while progressing toward the start of its planned Phase 2b trial in Post-Traumatic Stress Disorder (PTSD) in the middle of this year. BNC210 is a novel, negative allosteric modulator of the a7 nicotinic acetylcholine receptor in development for the treatment of anxiety and stressor-related disorders, and in November 2019 was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of PTSD. In addition to PTSD, a previous successful Phase 2a study in GAD patients demonstrated that acute administration of the liquid suspension formulation of BNC210 had significant anti-anxiety effects as measured in brain imaging and behavioural studies similar to benzodiazepines such as lorazepam but without evidence for sedation or addictive potential. The slow absorption of the liquid suspension formulation of BNC210 and the requirement for it to be taken with food for optimal absorption limited its use for the acute treatment of anxiety in patients with SAD. A new solid dose tablet formulation of BNC210 has been successfully developed, showing much improved and rapid absorption over the previous liquid suspension formulation, and will be used for the Phase 2 efficacy clinical trials in SAD and PTSD. The Phase 2b PTSD trial protocol has been developed with input from Bionomics' Clinical Advisory Board members and will compare BNC210 (900 mg twice daily) to placebo on the improvement in PTSD symptom severity as measured by the Clinician Administered PTSD scale for DSM-5 (CAPS-5) following 12 weeks of treatment. The dose of BNC210 has been selected based on achieving exposure levels that are predicted from a pharmacometric model, built on a previous BNC210 trial data set (RESTORE), as necessary to meet the primary endpoints for effectiveness for treating PTSD patients in clinical trials. Manufacturing of the drug supply for the trial is progressing well, and tablets for both BNC210 and placebo will soon be undergoing final testing, packaging, and labelling. Premier Research has been selected to manage the Phase 2b PTSD trial. Premier Research will work in partnership with Dr. Frank Weathers, author of the CAPS-5, to deliver the training program to clinical site raters in the use of the CAPS-5 assessment in Bionomics' Phase 2b clinical trial, ensuring collection of robust and reliable study data for the primary endpoint measure. Study start-up activities are underway including clinical site identification and selection. It is anticipated that around 25 sites in the U.S. will be involved in the trial, recruiting approximately 200 PTSD patients. The trial protocol will soon be submitted to the U.S. FDA and a central human ethics Institutional Review Board (IRB), in time for the commencement of the study in the middle of this year. Executive Departure • Mar 25
Legal Counsel & Company Secretary has left the company On the 23rd of March, Jack Moschakis' tenure as Legal Counsel & Company Secretary ended after 5.9 years in the role. As of December 2020, Jack personally held only 35.52k shares (AU$5.2k worth at the time). A total of 2 executives have left over the last 12 months. Aankondiging • Mar 04
Bionomics Limited has completed a Follow-on Equity Offering in the amount of AUD 15.991634 million. Bionomics Limited has completed a Follow-on Equity Offering in the amount of AUD 15.991634 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 110,287,132
Price\Range: AUD 0.145
Transaction Features: Subsequent Direct Listing Is New 90 Day High Low • Feb 26
New 90-day high: AU$0.39 The company is up 200% from its price of AU$0.13 on 27 November 2020. The Australian market is up 5.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 11% over the same period. Aankondiging • Feb 22
Bionomics Limited Announces Positive BNC210 PK Results for Solid Dose Formulation Bionomics Limited announced positive pharmacokinetic (PK) results from a 7- day dosing study in healthy volunteers using the newly developed solid dose oral tablet formulation of BNC210. BNC210 is a novel, negative allosteric modulator of the alpha 7 nicotinic acetylcholine receptor in development for the treatment of anxiety and stressor-related disorders, and in November 2019 was granted Fast Track designation by the US Food and Drug Administration (FDA) for the treatment of Post-Traumatic Stress Disorder (PTSD). The 7-day dosing PK study in ten healthy volunteers (females and males) demonstrated that at a dose of 900 mg given twice daily, the tablet formulation of BNC210 had steady-state 12-hourly exposure levels ranging from 33-57 mg.h/L which exceed the 12-hourly blood exposure of 25 mg.h/L predicted as necessary to meet the primary endpoints for effectiveness for treating PTSD patients in future clinical trials. A pharmacometric analysis of data from the first Phase 2 PTSD trial (RESTORE) that read out in October 2018, modelled an exposure-response relationship between BNC210 blood levels and CAPS-5 scores (the primary endpoint measure in PTSD trials), and the potential for BNC210 to treat PTSD symptoms provided that adequate blood exposure could be achieved. The tablet formulation of BNC210 replaces the liquid suspension formulation used in RESTORE which did not provide sufficient blood exposure for efficacy in that Study. The BNC210 tablet will be easier for the PTSD trial participants to administer and, unlike the liquid suspension formulation, is not dependent on food intake for maximal absorption and is therefore expected to result in substantially less variable exposure in the patients in the next Phase 2b PTSD study. Furthermore, the recent PK results show that there is no gender-based difference in exposure and that BNC210 continues to be well-tolerated, even at the higher exposure levels achieved after 7 days of dosing in the healthy volunteers. Aankondiging • Feb 18
Bionomics Limited and EmpathBio Inc Joint Feasibility Assessment Bionomics Limited announced that it has entered into a Memorandum of Understanding with EmpathBio Inc. (EmpathBio) atai Life Sciences (atai). Under the Memorandum of Understanding, Bionomics and EmpathBio propose to collectively explore a combination drug treatment regimen with Bionomics' BNC210 and EmpathBio's 3,4-Methylenedioxymethamphetamine (MDMA) derivative EMP-01. The parties will explore whether the different mechanisms of action of EMP-01 and BNC210 may offer the potential for developing an improved treatment regimen for the treatment of Post-Traumatic Stress Disorder (PTSD). BNC210 is Bionomics' lead drug candidate, which has been granted Fast Track designation by the US Food and Drug Administration (FDA) for the treatment of PTSD and other trauma-related and stress-related disorders. A new solid dose formulation of BNC210 has recently been developed and will be used in a Phase 2 study in PTSD, projected to commence in the middle of 2021. MDMA-assisted psychotherapy (two to three treatment sessions) has demonstrated significant symptom improvement in PTSD patients which continued at least 12 months post-treatment (Jerome et al., Psychopharmacology 237: 2485-2497, 2020). The FDA has granted a Breakthrough Therapy designation to MDMA-assisted psychotherapy, which is currently in Phase 3 trials being conducted by US not-for-profit organisation, the Multidisciplinary Association for Psychedelic Studies (MAPS). EmpathBio's EMP-01 is one of 11 programs in atai's pipeline. EmpathBio specifically focuses on developing MDMA derivatives that EmpathBio believes may permit the entactogenic effects of MDMA to be separated from some of the known adverse effects. If successful, such an approach could help minimise some of the transient physiological changes caused by MDMA, potentially expanding the pool of PTSD patients who will be medically eligible for the therapy. Aankondiging • Feb 11
Bionomics Limited announced that it expects to receive AUD 15.991634 million in funding Bionomics Limited (ASX:BNO) announced that it has entered into placement agreements with a number of North American and European institutional and sophisticated investors including specialist life sciences investment funds for private placement of 110,287,130 shares at a price of AUD 0.145 per share for gross proceeds of AUD 15,991,633.85 on February 10, 2021. Completion of the placement is anticipated to be on February 26, 2021. The company will pay AUD 50,000 as legal and admin expenses. Is New 90 Day High Low • Feb 05
New 90-day high: AU$0.22 The company is up 100% from its price of AU$0.11 on 06 November 2020. The Australian market is up 11% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 8.0% over the same period. Aankondiging • Jan 20
Bionomics Limited Completes Treatment Phase in the MODULATE Clinical Trial Bionomics Limited announced that all patients have completed their treatment phase in the MODULATE clinical trial, an experimental Phase 2 trial of BNC105 in combination with Bristol Myers Squibb's nivolumab (OPDIVO®) in patients with metastatic colorectal cancer. The trial Sponsor, the Australasian Gastro-Intestinal Trials Group (AGITG), is expecting that results will be ready in the second quarter 2021 which is ahead of the previously announced timeline for topline data of early 2023. The AGITG (www.gicancer.org.au) is conducting the MODULATE trial to evaluate new experimental approaches to immunotherapy treatment in colorectal cancer patients. In one arm of the trial, it is investigating whether Bionomics' BNC105, a vascular disrupting agent, combined with nivolumab, a PD-1 (programmed death-1) immune checkpoint inhibitor, can be used to treat advanced colorectal cancer patients who have exhausted other treatment options. A second group of patients are receiving nivolumab in combination with a Signal Transduction Activator of Transcription (STAT3) inhibitor. Aankondiging • Jan 19
Bionomics Limited Announces Publication of Positive BNC210 Phase 2a Data in Gad Patients Bionomics Limited company announced the online publication of their paper entitled Cholinergic Modulation of Disorder-Relevant Human Defensive Behaviour in Generalised Anxiety Disorder authored by Perkins et. al. in the peer-reviewed journal Translational Psychiatry 11:13 (2021). Using a computerised test of human threat-avoidance or defensive behaviour called the Joystick Operated Runway Task, BNC210 significantly reduced Flight Intensity relative to placebo in 21 female GAD patients. The same patients also reported significantly reduced levels of anxiety following administration of BNC210 compared to placebo, providing a behavioural-emotional link that suggests BNC210 has general promise as a drug to treat anxiety. Additional data from the same study were published last year (Wise et. al., Cholinergic Modulation of Disorder-Relevant Neural Circuits in Generalized Anxiety Disorder, Biological Psychiatry 87:908-915, 2020) and showed, with functional magnetic resonance imaging (fMRI) of the brain, that BNC210 treatment significantly reduced amygdala reactivity to "fearful faces" relative to placebo and reduced connectivity between the amygdala and the anterior cingulate cortex network in GAD patients. fMRI studies have previously shown that GAD is associated with hyperactivity and connectivity in the amygdala-anterior cingulate cortex networks in the brain, and the normalisation of this irregular activity is thought to be critical for successful anxiety treatment. BNC210, Bionomics' proprietary compound, is a novel, negative allosteric modulator (NAM) of the alpha 7 nicotinic acetylcholine receptor (7 nAChR) in development for the treatment of anxiety and stressor-related disorders. It has been granted Fast Track designation by the US Food and Drug Administration (FDA) for the treatment of Post-Traumatic Stress Disorder (PTSD) and other trauma-related and stress-related disorders. Aankondiging • Jan 04
Bionomics Limited Initiates 7-Day Dosing Pharmacokinetic Study of BNC210 Bionomics Limited announced the initiation of a 7-day dosing pharmacokinetic (PK) study in healthy volunteers using the newly developed solid dose tablet formulation of Bionomics' lead drug candidate, BNC210. BNC210 has been granted Fast Track designation by the US Food and Drug Administration (FDA) for the treatment of Post-Traumatic Stress Disorder (PTSD) and other trauma-related and stress- related disorders. The new solid dose formulation of BNC210 has been developed to overcome the failure of the liquid suspension formulation (which has a requirement to be taken with food) to provide sufficient blood exposure for efficacy in the first BNC210 Phase 2 PTSD trial, RESTORE, that read out in October 2018. Pharmacometric analysis of data from the RESTORE trial modelled an exposure-response relationship (between BNC210 blood levels and the primary endpoint measure in PTSD clinical trials, CAPS-5 severity scores), and the potential for BNC210 to treat PTSD symptoms provided that adequate blood levels can be achieved. Pharmacokinetic data from the earlier single dose PK studies demonstrated that the tablet formulation does not have a requirement to be given with food and can reach blood levels required to achieve exposures predicted by pharmacometric modelling to give clinically meaningful and statistically significant results in PTSD patients. The results from this 7-day, twice daily dosing PK clinical trial in healthy subjects with the tablet formulation of BNC210 will be used to determine the dosing regimen of BNC210 that will be given to PTSD patients in a second Phase 2 clinical trial. Aankondiging • Nov 19
Bionomics Limited Licenses Drug Candidate BNC101 to Carina Biotech Bionomics Limited announced that it has entered into an exclusive Agreement to license Bionomics' BNC101 oncology drug candidate to Carina Biotech (Carina), for the development of Chimeric Antigen Receptor T cell (CAR-T) therapy, which harnesses the body's immune system to fight cancer. BNC101 is a First-in-Class Humanized Monoclonal Antibody to LGR5, which is overexpressed in cancer stem cells within solid tumors including colorectal, breast, pancreatic, ovarian, lung, liver and gastric cancers and has the potential to guide CAR-T therapeutic development. Under the worldwide, exclusive License Agreement, Carina will fund all research and development activities. Bionomics is eligible to receive up to A$118 million in clinical & development milestones plus royalty payments if Carina fully develops and markets the new therapy. In the event that Carina sub-licenses the CAR-T treatment, Bionomics is eligible to share in the sub-licensing revenues in early clinical development and receive a substantial double-digit portion of the revenues in later stages of clinical development. Aankondiging • Sep 24
Bionomics Limited Announces Director Changes Bionomics Limited announced that Dr. Srinivas Rao and Dr. Jane Ryan have been appointed Non-Executive Directors to the Board of Bionomics Limited from 1 October 2020. Dr. Rao is the Chief Scientific Officer at ATAI Life Sciences AG. Dr. Ryan will replace Mr. Peter Turner who has decided not to stand for re-election at the November 2020 AGM. Under the corporations Act 2001, the Company must have at least two Directors who ordinarily reside in Australia. Dr. Ryan has over 30 years of international experience in the pharmaceutical and biotechnology industries having worked in Australia, US and UK. She has held senior executive roles in management of research and development programs as well as business development and alliance management. Aankondiging • Sep 22
Bionomics Limited announced that it has received AUD 5.43332 million in funding from Apeiron Investment Group Ltd. and other investors On September 21, 2020, Bionomics Limited (ASX:BNO) closed the transaction. The company issued 54,333,000 shares for gross proceeds of AUD 2,173,320 in its second tranche and included participation from Apeiron Investment Group Ltd. and four exempt investors nominated by Apeiron Investment Group Ltd. The company issued 135,833,000 shares for gross proceeds of AUD 5,433,320 in the transaction.