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Bionomics Limited ABN 55 075 582 740 Statutory Accounts Director's Report In accordance with the Corporations Act 2001, the directors of Bionomics Limited ( Bionomics or “Company”) report on the Company and

Key Takeaway: 2023 Bionomics Limited ABN 55 075 582 740 Statutory Accounts In accordance with the Corporations Act 2001, the directors of Bionomics Limited ( Bionomics or Company ) report on the Company and the consolidated entity, being the Company and its controlled entities ( Group ),

Full Press Release Details

2023
Bionomics Limited
ABN 55 075 582 740
Statutory Accounts
In accordance with the Corporations Act 2001, the directors of Bionomics Limited ( Bionomics or Company ) report on the Company and the consolidated entity, being the Company and its controlled entities ( Group ), for the year ended 30 June 2023 ( the year or the period ).
The following persons were Directors of Bionomics Limited during the period and up to the date of this report:
-Mr Alan Fisher, Non-Executive Director from 1 July 2022 to 30 June 2023 and Non-Executive Chairman from 1 July 2023
-Dr Errol De Souza, Executive Chairman from 1 July 2022 to 31 December 2022, Non-Executive Chairman from 1 January 2023 to 30 June 2023 and Non-Executive Director from 1 July 2023
-Mr David Wilson, Non-Executive Director
-Mr Aaron Weaver, Non-Executive Director
-Dr Jane Ryan, Non-Executive Director
-Mr Miles Davies, Non-Executive Director
-Dr Spyros Papapetropoulos, President, Chief Executive Officer and Executive Director from 5 January2023
Except as noted, the above-named Directors held their current positions for the whole of the financial year and since the end of the financial year.
Principal Activities
The principal activities of the Group during the period were the development of novel drug candidates focused on the treatment of central nervous system ( CNS ) disorders.
Review of Operating Results
Cash at 30 June 2023 of $18,250,255, represents a decrease of $15,314,602 from cash at 30 June 2022 of $33,564,857. The net decrease in cash is due to the following:
-net cash used in operating activities of $21,343,368 due to payments to suppliers and employees of $28,055,945 and payments for finance costs of $29,230 offset by the receipt of a research & development tax incentive of $6,719,760 and a licence fee received of $22,047; and
-foreign exchange loss of $7,625 on US bank balances
-net cash inflows from interest income of $479,528; and
-cash inflows from financing activities of $5,556,863 due to net proceeds from share issues of $5,716,903 offset by principal element of lease payments of $160,040.
The operating loss after tax for the year ended 30 June 2023 increased to $31,846,957 compared to $21,759,358 for the year ended 30 June 2022, an increase of $10,087,599 mainly due to:
-Other income for the year decreased by $5,170,803 to $627,559 due to a decrease in eligible expenditure that qualified for the Government research and development incentive.
-Research and development expenses for the year increased by $3,614,271 to $19,613,270 due to an increase in the costs of the two clinical trials [the ATTUNE Study in post-traumatic stress disorder ( PTSD ) and the PREVAIL Study in social anxiety disorder ( SAD )], and work in relation to preparation for an End-of-Phase 2 meeting with the US Food and Drug Administration (FDA) to discuss a Phase 3 clinical program in SAD.
-Administration expenses for the year increased by $1,237,704 to $8,636,180 mainly due to:
an increase in staff and consultant expenses following the appointment of a CEO from 5 January 2023 and increased use of consultants;
an increase in investor relation fees due to an increase in investor relation activities;
an increase in Director fees due to an increase in Executive Chairman's consulting fees due to the transitional payout and bonus payable, effective 31 December 2022, as a result of the appointment of the new CEO on 5 January 2023, offset by no Director fees for the period as Non-Executive Director for the period 1 January 2023 to 30 June 2023;
an increase in staff recruitment costs due to the recruitment process for the CEO;
an increase in Board meeting costs (covering airfares, accommodation, meals etc.) due to two face-to-face Board meetings in Adelaide in the current year compared to one in the prior year;
an increase in licence fees and permits, and seminars and conferences expenses.
-a decrease in employee share-based payment expenses related to the amortisation of the fair value of share options over their vesting period; and
-a decrease in once-off expenses as in the current year there are costs associated with the preparation and filing of the shelf (F-3) and At-the-Market ( ATM )program documents for future capital raise. Whereas in the prior year there were fees paid to external consultants for the Contingent Value Rights ( CVR ) transaction that did not proceed.
Review of Operations
Bionomics is a clinical-stage biotechnology company developing novel, allosteric, and orthosteric ion channel modulators designed to transform the lives of patients suffering from serious CNS disorders with high unmet medical need.
Ion Channel Expertise to Drive Growth
Ion channels serve as essential mediators of physiological function in the CNS, and the modulation of ion channels influences neurotransmission that affects downstream signalling in the brain. The 7 nicotinic acetylcholine ( nACh ) receptor ( 7 receptor ) is an ion channel that plays an important role in modulating emotional responses and cognitive performance. Utilising our expertise in ion channel biology and translational medicine, we are developing orally active small molecule negative allosteric modulators ( NAMs ) and positive allosteric modulators ( PAMs ) of the 7 receptor to treat anxiety-related disorders and cognitive dysfunction disorders, respectively. Bionomics' CNS pipeline also includes preclinical assets that target Kv3.1/3.2 and Nav1.7/1.8 ion channels. The Company is seeking strategic partners to advance its preclinical assets.
BNC210 Proprietary Pipeline Expansion and Continued Development
Bionomics is advancing its lead product candidate, BNC210, an oral, proprietary selective NAM of the 7 receptor for the acute treatment of SAD and chronic treatment of PTSD.
This year the Company completed its Phase 2 PREVAIL Study (NCT05193409) to evaluate BNC210 for the acute treatment of SAD. The PREVAIL Study is a randomised, double-blind, placebo-controlled, multi-centre Phase 2 clinical trial with a single dose treatment in 151 adult patients with SAD. The PREVAIL Study topline data were reported on 19 December 2022. The Company believes that the topline data, together with post-hoc analysis results reported on 9 March 2023, support the progression of BNC210 into Phase 3. On 13 September 2023, an End-of-Phase 2 meeting was held with the US FDA to review results from the PREVAIL Study and to obtain feedback on a proposed Phase 3 registrational program that would support the submission of a new drug application ( NDA ) for BNC210 for the treatment of SAD. Contingent upon final written minutes from the FDA meeting, the Company is planning to initiate a Phase 3 study in SAD during the quarter ending 31 March 2024 contingent upon securing funds to execute on the program.
The company also recently announce the results of ATTUNE study which was a double-blind, placebo-controlled Phase 2b trial conducted in a total of 34 sites in the United States and the United Kingdom, with 212 enrolled patients, randomized 1:1 to receive either twice daily 900 mg BNC210 as a monotherapy (n=106) or placebo (n=106) for 12 weeks. The trial met its primary endpoint of change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total symptom severity score from baseline to Week 12 (p=0.048). A statistically significant change in CAPS-5score was also observed at Week 4 (p=0.016) and at Week 8 (p=0.015).
Treatment with BNC210 also showed statistically significant improvement both in clinician-administered and patient self-reporting in two of the secondary endpoints of the trial. Specifically, BNC210 led to significant improvements at Week 12 in depressive symptoms (p=0.041) and sleep (p=0.039) as measured by Montgomery- sberg Depression Rating Scale (MADRS) and Insomnia Severity Index (ISI), respectively. BNC210 also showed signals and trends across visits in the other secondary endpoints including the clinician and patient global impression - symptom severity (CGI-S, PGI-S) and the Sheehan Disability Scale (SDS).
Treatment with 900 mg twice daily BNC210 had a favorable safety and tolerability profile. The most common (>5% of subjects in each group) reported adverse events, including headache, nausea, and fatigue, which were consistent with previous studies with BNC210. A hepatic enzyme increase was observed in 14 (13.3%) patients treated with BNC210 vs 2 (0.19%) in the placebo group; the abnormal results were not associated with hepatic injury and in most cases were resolved without drug discontinuation. The Company plans to engage with the U.S. Food and Drug Administration (FDA) to discuss the registrational path for BNC210 in PTSD.
Additionally, the Company recently held what it believes was a successful, Phase 3-enabling End-of-Phase 2 meeting with the FDA for the advancement of BNC210 for the acute treatment of social anxiety disorder into registrational studies and is awaiting receipt of the formal meeting minutes.
Novel Approach in Large Market with Significant Unmet Need
There remains a significant unmet medical need for over 22 million patients in the US alone suffering from SAD and PTSD. Current pharmacological treatments include certain antidepressants and benzodiazepines, and there have been no new FDA-approved therapies in these indications in nearly two decades. These existing treatments have multiple shortcomings, such as a slow onset of action of antidepressants and significant side effects in both classes of drugs. BNC210 has been observed in clinical trials to have a fast onset of action and has demonstrated anti-anxiety and antidepressant effects but without many of the limiting side effects observed with the currently available medications.
Strong Ongoing Collaboration with MSD
The Company's expertise in ion channels and approach to developing allosteric modulators have been validated through its strategic partnership with Merck Sharpe & Dohme ( MSD , known as Merck in the US and Canada) for our 7 receptor PAM program, which targets a receptor that has garnered significant attention for treating cognitive deficits. This partnership enables Bionomics to maximise the value of its ion channel and chemistry platforms and develop transformative medicines for patients suffering from cognitive disorders such as Alzheimer's disease and other CNS conditions.
In 2014 Bionomics entered into an exclusive Research Collaboration and License Agreement with MSD to develop 7 Receptor PAM targeting cognitive dysfunction associated with Alzheimer's disease and other CNS conditions.
MSD funds all research and clinical development, and worldwide commercialization of any resulting products. This collaboration generated payments of US$20M upfront and US$10M for a Phase 1 milestone. Bionomics is eligible to receive up to US$465M in additional milestone payments for certain development and commercial milestones plus royalties on net sales of licensed drugs.
The original lead molecule BNC375, a Type I 7 nAChR PAM, showed a robust and sustained dose-dependent efficacy over a broad dose range and across multiple cognitive animal models. MSD has subsequently developed MK-4334, a novel clinical candidate, which in early preclinical studies has shown improved drug like and pharmacological properties relative to BNC375. In addition to Phase 1 safety, tolerability and clinical pharmacokinetics studies, clinical biomarker studies are ongoing to further evaluate the pharmacological response of 7 nAChR PAMs in humans. In addition to MK-4334 a second molecule that showed an improved potency profile in preclinical animal models and was advanced by MSD under this collaboration into Phase 1 clinical trials.
Leveraging the Value of Legacy Oncology Assets
Bionomics continues limited activities to maximise the value of our legacy oncology programs through external funding of clinical development and divestment/out-licensing.
The Company entered an exclusive agreement to license its BNC101 oncology drug candidate to Carina Biotech (Carina) to develop Chimeric Antigen Receptor T cell (CAR-T) therapy, which harnesses the body's immune system to fight cancer. BNC101 is a first-in-class humanised monoclonal antibody to LGR5, which is overexpressed in cancer stem cells within solid tumours 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 $118 million in clinical and 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 the
later stages of clinical development. On 24 January 2023, Carina announced that it had received an FDA Safe to Proceed Letter for a Phase 1/2a clinical trial of BNC101 CAR-T therapy for the treatment of advanced colorectal cancer. On 25 August 2023, Carina announced that patient screening for their Phase 1/2a study had commenced.
Bionomics remains focused on developing its ongoing clinical programs with BNC210 in SAD and PTSD. Bionomics will receive formal minutes from the FDA End-of-Phase 2 meeting by mid-October 2023, and is currently pursuing start-up activities for a Phase 3 study in SAD planned to commence during the quarter ending 31 March 2024 contingent upon securing funds to execute on the program.
The Directors do not propose to make any recommendation for dividends for the current financial year. There were no dividends declared in respect of the previous financial year or in the history of Bionomics.
Significant Changes in the State of Affairs
There have been no significant changes in the state of affairs of the Group during the financial year.
As from the close of trading on 28 August 2023, Bionomics delisted from the ASX and is now only listed on the NASDAQ.
On 8 May 2023, Bionomics announced the establishment of an ATM Program with Cantor, who will act as sales agent. During the month of September 2023 and up to the date of this report, Cantor sold under the ATM Program, 2,100,866 ADSs (378,155,880 ordinary shares) raising gross proceeds of US$6,715,878. Net proceeds after deducting Cantor's commission and the ADS issuance fee were US$6,409,359.
There are no other matters or circumstances that have arisen since the end of the financial year which significantly affect or may significantly affect the results of the operations of the Group.
Likely Developments and Expected Results of Operations
The Group will continue to undertake drug and clinical development and will seek to commercialise the outcomes.
Environmental Regulation
The Group is not subject to environmental regulations and other licenses in respect of its facilities in Australia.
Share Options Granted to Directors and Other Key Management Personnel ( KMP )
During and since the end of the financial year, an aggregate of 44,567,015 options over fully paid ordinary shares were granted by Bionomics Limited to the following directors and KMPs. Information about these share options, their vesting conditions and how the share options were valued are set out in Note 20 to the financial statements.:
Name Number of options granted
Dr Spyros Papapetropoulos 27,067,015
Dr Errol De Souza (i) 10,000,000
Mr Adrian Hinton 2,000,000
Mr Connor Bernstein(ii) 3,500,000
Ms Liz Doolin 2,000,000
(i) 1,666,666 of these share options were cancelled as at the date of issue of the share options as the vesting condition, the data readout for Phase2 trial for BNC210 in SAD had been announced and was deemed not successful and 1,666,666 vested on issue as the vesting condition had been met (appointment of a CEO).
(ii) As Mr Connors consultancy agreement was not renewed on 30 June 2023 these share options were forfeited on 30 June 2023.
Information relating to shares under option or warrants is set out in Note 20 to the financial statements. The total number of shares under option as at 30 June 2023 was 117,211,315 under the Employee Equity Plan ( EEP ),
Employee Share Option Plan ( ESOP ) and other offers. The total number of shares under warrants as at 30 June 2023 was 142,000,000.
The holders of these options or warrants do not have the right, by virtue of the option, to participate in any share issue, dividend or voting of members of the Company.
Since the end of the year and up to the date of this report: 25,000 share options lapsed and 142,000 warrants lapsed.
Shares Issued on the Exercise of Options and Warrants
During the year ended 30 June 2023 or up to the date of this report, no ordinary shares of Bionomics were issued on the exercise of options granted under the Company's equity incentive plans or on the exercise of warrants.
Insurance of Directors and Officers
During the financial year, the Company paid a premium to insure the D&O of the Company. Under the terms of this policy, the premium paid by the Company is not permitted to be disclosed.
The liabilities insured are legal costs that may be incurred in defending civil or criminal proceedings that may be brought against the D&O in their capacity as D&O of the Company, and any other payments arising from liabilities incurred by the D&O in connection with such proceedings, other than where such liabilities arise out of conduct involving a willful breach of duty by the D&O or the improper use by the D&O of their position or of information to gain advantage for themselves or someone else or to cause detriment to the Company.
It is not possible to apportion the premium between amounts relating to the insurance against legal costs and those relating to other liabilities.
The Company has not otherwise, during or since the end of the financial year, except to the extent permitted by law, indemnified or agreed to indemnify an officer or auditor of the Company or of any related body corporate against a liability incurred as such an officer or auditor.
The Company may decide to employ the external auditor on assignments additional to their statutory audit duties where the external auditor's expertise and experience with the Group are important. Details of the amounts paid to the external auditor for audit and non-audit services provided during the year are set out in Note 25 to the financial statements. The Board has considered the position and, in accordance with the advice received from the Audit and Risk Management Committee, is satisfied that the provision of the non-audit services is compatible with the general standard of independence for external auditors imposed by the Corporations Act 2001.
Auditor's Independence Declaration
The auditor's independence declaration as required under section 307C of the Corporations Act 2001 is included after this report.
Information on Directors
Mr Alan Fisher BCom, FCA, MAICD
Non-Executive Chairman from 1 July 2023.
Non-Executive Director appointed 1 September 2016.
Experience and Expertise
Mr Fisher is an experienced corporate advisor and public company director. He has a proven track record for implementing strategies that enhance shareholder value. His main areas of expertise include mergers and acquisitions, public and private equity raisings, business restructurings and strategic advice.
Current Directorships (in addition to Bionomics Limited)
Non-Executive Director of Centrepoint Alliance Limited (ASX:CAF) from 12 November 2015 and will resign from the Board effective 30 September 2023; Non-Executive Director and Chair of the Audit and Risk Committee of Thorney Technologies Limited (ASX:TEK) from 29 August 2014 to present.
Former Listed Directorships in Last Three Years
IDT Australia Limited (ASX:IDT) from 10 June 2015 to 31 December 2022
Simavita Limited (formerly ASX:SVA) 22 July 2019 to 21 December 2021.
Special Responsibilities
Member of the Nomination and Remuneration Committee
Chair of the Audit and Risk Management Committee
Interests in Shares and Options at Date of Report
100,000 ordinary shares in Bionomics Limited (as shares or as ADSs traded on NASDAQ)
400,000 unlisted options over ordinary shares in Bionomics Limited
Last updated: Sep 29, 2023