Full Press Release Details
ASX half-year information
Lodged with the ASX under Listing Rule 4.2A
| Contents | Page |
| Results for Announcement to the Market | 2 |
| Announcement | 3 |
| Half-year Report | 6 |
Half-year ended 31 December 2021
(Previous corresponding period: Half-year ended 31 December 2020)
Results for announcement to the market
| A$ | ||||
| Cash and cash equivalents at 31 December 2021 from 30 June 2021 | increased by | 41.6% | to | 40,351,584 |
| Net operating cash outflows for the period | increased by | 887.2% | to | 12,839,159 |
| Net investing cash inflows for the period | increased by | 1,052.0% | to | 614,315 |
| Net financing cash inflows for the period | increased by | 907.4% | to | 24,575,866 |
| Loss for the half-year before income tax from continuing operations | increased by | 11,959.8% | to | 13,148,561 |
| Loss for the half-year after tax | increased by | 102,400.7% | to | 13,053,471 |
Explanation of cash and cash equivalents position as at 31 December 2021
Closing cash and cash equivalents is in line with expectations, with net funds raised through share issues and used to continue to progress the BNC210 development and pay operating expenditure.
Explanation of operating outflows
Net cash outflows from operating activities increased during the period due to;
-not receiving the research and development incentives for the year ended 30 June 2021, as the Company has not lodged the claim for the year ended 30 June 2021 due to discussion with AusIndustry to enable our expenditure for the current PTSD clinical trial to be approved as eligible expenditure; and
-an increase in payments to suppliers and employees, due to increased activities and a decrease in interest paid as a result of repaying the bank and equipment loans during April 2021.
Explanation of net investment inflows
Net cash inflows from investing activities increased during the period as a result of an increase in proceeds from other financial assets (term deposits) and sale of plant and equipment.
Explanation of net financing inflows
Net cash inflows from financing activities increased during the period as a result of net proceeds from share issues received and a decrease in borrowing and principal elements of leases repayments.
Explanation of net loss from ordinary activities after tax
The increase in half-year loss principally reflects the reduction in other income (decrease in research and development incentive), other (losses) and gains (decrease in the change in fair value of contingent consideration and unfavourable movement in foreign exchange rates), increase in research and development expenses, administration expenses and offset by a reduction in occupancy expenses.
Dividends / distributions
Bionomics Limited does not propose to pay any dividends for the half-year ended 31 December 2021.
| Half-year | ||
| 31 December 2021 | 31 December 2020 | |
| Net tangible asset backing per ordinary share | 2.90 cents | (0.85) cents |
BIONOMICS' HALF-YEAR REPORT
Adelaide, Australia: Bionomics Limited (ASX: BNO, Nasdaq: BNOX), today announced its half-year report for the half-year ended 31 December 2021. The half-year ending 31 December 2021 represented a transformational period for Bionomics in which the Company made great strides on multiple fronts including the areas of pipeline progress and advancements, capital raising and implementation of corporate strategic initiatives getting the Company back on a renewed value-driving trajectory to create long-term shareholder value.
In the area of internal pipeline progress and advancements, in July 2021 the Company announced that it had initiated a Phase 2b trial (the ATTUNE Study) to evaluate the tablet formulation of BNC210 in patients with Post-Traumatic Stress Disorder (PTSD) with topline results expected in CY1H 2023. The ATTUNE Study is a randomised, double-blind, placebo-controlled, multi-centre Phase 2b clinical trial with a 12-week treatment period conducted at around 25 clinical sites in the U.S., recruiting approximately 200 patients with PTSD.
In September 2021, the Company announced that, as part of its broader pipeline expansion strategy and based on anti-anxiety signals in Generalised Anxiety Disorder patients, it had started preparing for initiation of a study by year end to evaluate its lead clinical compound, BNC210, as an acute treatment for Social Anxiety Disorder (SAD). In November 2021, the Company received U.S. Food and Drug Administration (FDA) clearance to proceed with evaluating BNC210 for the acute treatment of SAD in a Phase 2 clinical trial (the PREVAIL Study) and in December 2021, the U.S. FDA granted Fast Track designation to the program for the acute treatment of SAD and other anxiety-related disorders.
In early January 2022, the Company announced that it had initiated its Phase 2 PREVAIL Study to evaluate BNC210 for the acute treatment of SAD, with topline results expected by the end of 2022. The PREVAIL Study is a randomised, double-blind, placebo-controlled, multi-centre Phase 2 clinical trial with a single dose treatment, conducted at around 15 to 20 clinical sites in the U.S. and recruiting approximately 150 patients with SAD.
Whilst the internal focus and current research and development spend is restricted to CNS programmes, Bionomics continues limited activities to maximise the value of its legacy oncology programs through divestment and/or out-licensing of both BNC101 and BNC105. Of the non-core legacy oncology assets, the exclusive license agreement of BNC101 to Carina Biotech continued to make advancements and is expected to move forward into clinical development in late 2022. The Memorandum of Understanding the Company entered into in February 2021 with EmpathBio for exploring a potential combination of BNC210 and EMP-01 (an MDMA derivative) for the treatment of PTSD continued to progress in animal feasibility studies.
Bionomics also continued to see progress in its continuing partnership with Merck & Co (known as MSD outside the United States and Canada) to develop 7 receptor positive allosteric modulators (PAMs) targeting cognitive impairment in Alzheimer's disease with two compounds undergoing Phase 1 safety and biomarker clinical trials.
The Company has also achieved several important capital raising and corporate strategic initiative milestones over the six-month period.
In August 2021, the Company announced that it planned to conduct an initial public offering in the United States (the Offering) of American Depositary Shares (ADSs) and concurrent listing of ADSs on Nasdaq. In December 2021, the Company announced the pricing and close of its the Offering of 1,622,000 ADSs, each representing 180 ordinary shares of Bionomics, at an initial public offering price of US$12.35 per ADS.
The gross proceeds from the Offering were US$20 million, before deducting underwriting discounts and commissions, and other offering expenses payable by Bionomics. The amount raised after deducting underwriting discounts and commissions, and other offering expenses was A$22.2 million. The ADSs began trading on the Nasdaq Global Market on 16 December 2021 under the ticker symbol BNOX . The Company granted the underwriters a 30-day option to purchase up to an additional 243,300 ADSs at the public offering price per ADS, less underwriting discounts.
On 6 January 2022, the underwriters exercised in full the underwriters' option to purchase additional ADSs and 243,300 ADSs were issued at US$12.35 per ADS raising gross proceeds of US$3.0 million. The net proceeds received were US$2.8 million after deducting underwriting discounts and commissions.
The total gross proceeds from the Offering were US$23.04 million, before deducting underwriting discounts and commissions and other offering expenses payable by Bionomics.
Following the closing of the Offering, Bionomics participated virtually in the Nasdaq Stock Market Closing Bell virtual ceremony in celebration of its ADSs trading on the Nasdaq Global Market under the ticker symbol BNOX .
The Board of Directors underwent several changes over the half-year ended 31 December 2021. In July 2021, the Company announced the appointment of Mr Miles Davies as a Non-Executive Director to the Board of Bionomics Limited, replacing Dr. Srinivas Rao as the second Board nominee of Apeiron Investment Group Ltd (Apeiron) under the Subscription Agreement dated 1 June 2020 between the Company and Apeiron.
On 31 December 2021, the Company announced the resignation of Mr Mitchell Kaye as a Non-Executive Director of the Board of Bionomics Limited effective 31 December 2021. Mr Kaye resigned under the terms of the agreement through which he was appointed in November 2018, as nominee of BVF Partners LP under the Placement Agreement dated 9 November 2018.
The Company's cash balance at 31 December 2021 was A$40.35 million (30 June 2021: A$28.50 million).
FOR FURTHER INFORMATION, PLEASE CONTACT:
| Bionomics Limited | Bionomics Limited | ||
| Adrian Hinton | Ms Suzanne Irwin | ||
| Acting Chief Financial Officer | Company Secretary | ||
| +61 8 8150 7400 | +61 8 8150 7400 | ||
| ahinton@bionomics.com.au | CoSec@bionomics.com.au |
About Bionomics Limited
Bionomics (ASX:BNO, NASDAQ:BNOX) is a clinical-stage biopharmaceutical company developing novel, allosteric ion channel modulators designed to transform the lives of patients suffering from serious central nervous system (CNS) disorders with high unmet medical need. Bionomics is advancing its lead drug candidate, BNC210, an oral, proprietary, selective negative allosteric modulator of the 7 nicotinic acetylcholine receptor, for the acute treatment of Social Anxiety Disorder (SAD) and chronic treatment of Post-Traumatic Stress Disorder (PTSD). Beyond BNC210, Bionomics has a strategic partnership with Merck & Co, Inc (known as MSD outside the United States and Canada) with two drugs in early-stage clinical trials for the treatment of cognitive deficits in Alzheimer's disease and other central nervous system conditions.
Factors Affecting Future Performance
This announcement contains forward-looking statements within the meaning of the U.S. federal securities laws. Any statements contained in this announcement that relate to prospective events or developments, including, without limitation, statements related to the Offering are deemed to be forward-looking statements. Words such as believes, anticipates, plans, expects, projects, forecasts, will and similar expressions are intended to identify forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by these forward-looking statements. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Actual results could differ materially from those discussed in this ASX announcement.
Half-Year Report 31 December 2021
| Contents | Page |
| Directors' Report | 7 |
| Auditor's Independence Declaration | 12 |
| Consolidated Statement of Profit or Loss and Other Comprehensive Income | 13 |
| Consolidated Statement of Financial Position | 14 |
| Consolidated Statement of Changes in Equity | 15 |
| Consolidated Statement of Cash Flows | 16 |
| Notes to the Consolidated Financial Statements | 17 |
| Directors' Declaration | 24 |
| Independent Auditor's Review Report to the Members | 25 |
This interim financial report does not include all the notes of the type normally included in an annual financial report. Accordingly, this report is to be read in conjunction with the annual report for the year ended 30 June 2021.
Directors present their report on the consolidated entity (the Group) consisting of Bionomics Limited (the Company) and the entities it controlled at the end of, or during, the half-year ended 31 December 2021. In order to comply with the provisions of the Corporations Act 2001, the Directors report as follows:
The names of the Directors of the Company during or since the end of the half-year:
-Dr Errol De Souza, Executive Chairman
-Mr David Wilson, Non-Executive Director
-Mr Alan Fisher, Non-Executive Director
-Mr Aaron Weaver, Non-Executive Director
-Dr Jane Ryan, Non-Executive Director
-Dr Miles Davies, Non-Executive Director, appointed 1 July 2021
-Mr Mitchell Kaye, Non-Executive Director, resigned on 31 December 2021
Principal Activities
The principal activities of the Group during the period include the development of novel drug candidates focused on the treatment of central nervous system disorders (CNS).
The Directors do not propose to make any recommendation for dividends for the current financial year.
REVIEW OF OPERATING RESULTS
Cash during the half-year to 31 December 2021 increased by A$11,852,135 to A$40,351,584 at 31 December 2021 from A$28,499,449 at 30 June 2021. The increase is due to net increase in cash from activities during the half-year ended 31 December 2021 of A$12,350,022 offset by a foreign exchange loss from the effects of exchange rate changes on the balance of cash held in foreign currencies at 31 December 2021 of A$497,887. The net increase in cash from activities is due to the following:
-net cash inflows from investing activities of A$614,315, primarily due to proceeds from other financial assets (term deposits) of A$435,640 and sale of plant and equipment of A$175,091; and
-cash inflows from financing activities of A$24,574,866, due to net proceeds from share issues of A$24,673,768 offset by principal element of lease payments of A$98,902.
-net cash used in operating activities of A$12,839,159, primarily due to payments to suppliers and employees of A$12,820,515.
The operating loss after tax for the half-year ended 31 December 2021 increased to A$13,053,471, compared to A$12,735 for the half-year ended 31 December 2020, mainly as a result of:
-Other income for the half-year decreased by A$704,995 to A$176,992, compared to A$881,987 for the previous half-year. The decrease is principally due to a decrease in eligible expenditure that qualified for the Government research and development incentive.
-Other (losses) and gains for the half-year decreased by A$5,932,277 to a net loss of A$666,725, compared to a net gain of A$5,265,552 for the previous half-year. The change is due to changes in fair value of contingent consideration and an unfavourable movement in foreign exchange rates over the half-year ended 31 December 2021.
-Research and development expenses for the half-year increased by A$4,901,688 to A$6,955,274, compared to A$2,053,586 for the previous half-year, as a result of starting the ATTUNE Phase 2b PTSD clinical trial in the United States during July 2021.
-Administrative expenses for the half-year increased by A$2,543,957 to A$4,636,740, compared to A$2,092,783 for the previous half-year, mainly due to:
oan increase in employee share-based payment expenses due to the issue of share options to the Executive Chairman;
oan increase in staff and consultant expenses;
oan increase in Directors fees and consultant fees due to the new employment contract with the Executive Chairman; and
oone-off expenses in the half-year resulting from:
fees paid to external consultants for the Contingent Value Rights (CVR) transaction that did not proceed; and
Initial public offering (IPO) audit costs, that are not permitted to be recorded in issued capital and must be expensed.
-Occupancy expenses for the half-year decreased by A$510,422 to A$166,798, compared to A$677,220 for the previous half-year as a result of the Company moving to new premises in June 2021.
-Finance expenses for the half-year decreased by A$669,388 to A$25,985 compared to A$695,373 for the previous half-year due to the bank and equipment loans being fully repaid during April 2021.
REVIEW OF OPERATIONS
Bionomics is a clinical stage biopharmaceutical company developing novel, allosteric 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 important mediators of physiological function in the CNS and the modulation of ion channels influences neurotransmission that leads to downstream signaling in the brain. The a7 nicotinic acetylcholine (ACh) receptor (a7 receptor) is an ion channel that plays an important role in driving emotional responses and cognitive performance. Utilising our ion channel and chemistry platforms, coupled with our allosteric modulation approach, we are developing orally active small molecule negative allosteric modulators (NAMs) and positive allosteric modulators (PAMs) of the a7 receptor to treat anxiety related and cognitive disorders, respectively.
BNC210 Pipeline Expansion and Continued Advancement
Bionomics is advancing its lead product candidate, BNC210, an oral, proprietary selective NAM of the a7 receptor, for the acute treatment of Social Anxiety Disorder (SAD) and chronic treatment of Post-Traumatic Stress Disorder (PTSD).
In September 2021, Bionomics announced that as part of its broader pipeline expansion strategy and based on anti-anxiety signals in Generalised Anxiety Disorder patients, it would proceed with evaluating BNC210 as an acute treatment in SAD patients. In November 2021, the Company received U.S. Food and Drug Administration (FDA) clearance to proceed with evaluating BNC210 for the acute treatment of SAD in a Phase 2 clinical trial named the PREVAIL Study, and in December 2021, the U.S. FDA granted Fast Track designation to the program for the acute treatment of SAD
and other anxiety-related disorders. In early January 2022, the Company announced that it had initiated the PREVAIL Study, with topline results expected by the end of 2022.
Additionally, Bionomics continued to make advancements in the ongoing development of BNC210 in PTSD patients with the start of its planned Phase 2b ATTUNE Study. The ATTUNE study follows an earlier announcement of positive pharmacokinetic results from a 7-day dosing study in healthy volunteers using the newly developed solid dose oral tablet formulation of BNC210.
In July 2021, Bionomics initiated its Phase 2b ATTUNE trial, a randomised, placebo-controlled study to evaluate BNC210 for the treatment of PTSD and it expects to have topline data in the first half of 2023. An independent Safety Review Committee established to monitor participant safety throughout the study met on 2 February 2022 and having reviewed all the safety information available at that time concluded that the study should continue as planned.
The Company's expertise and approach have been validated through its strategic partnership with MSD (known as Merck in the United States and Canada) for our a7 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.
Novel Approach in Large Market Opportunity with Significant Unmet Need
There remains a significant unmet medical need for the over 22 million patients in the United States 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 of 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 current standards of care for SAD and PTSD.
Strong Ongoing Collaboration with MSD
Bionomics' collaboration with MSD for therapeutic candidates for the treatment of cognitive dysfunction in Alzheimer's disease and other conditions continues to progress through clinical development.
In June 2014, the Company entered into a research collaboration and license agreement with MSD to develop a7 receptor PAMs targeting cognitive impairment in conditions such as Alzheimer's disease, Parkinson's disease, schizophrenia and attention deficit hyperactivity disorder (ADHD). Under the 2014 agreement, MSD is funding all research and development activities, including clinical development and worldwide commercialisation of any products developed from the collaboration. The Company received an upfront payment of US$20 million at the inception of the collaboration, and another US$10 million in February 2017 when the first compound from the collaboration entered into Phase 1 clinical trials and may receive up to an additional US$465million in development and commercialisation milestone payments in addition to royalties from sales of the product(s).
The MSD collaboration currently includes two candidates that are in early-stage Phase 1 safety and biomarker clinical trials for treating cognitive impairment. The first compound has completed Phase 1 safety clinical trials in healthy subjects and there are ongoing plans for further biomarker studies. In 2020, a second molecule that showed an improved potency profile in preclinical animal models was advanced by MSD under this collaboration into Phase 1 clinical trials.
Leveraging Value of Legacy Oncology Assets
Bionomics continued limited activities to maximise the value of our legacy oncology programs BNC101 and BNC105 through external funding of clinical development and divestment/out-licensing.
The Company entered into an exclusive agreement to license its 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 humanised monoclonal antibody to LGR5, which is overexpressed in cancer stem cells within solid tumours 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 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 later stages of clinical development. In September 2021, Carina announced that it plans to initiate a clinical trial of BNC101 CAR-T therapy for the treatment of advanced colorectal cancer in late 2022.
An experimental Phase 2 clinical trial of Bionomics' cancer drug candidate, BNC105, in combination with Bristol-Myers Squibb's nivolumab (OPDIVO ) completed recruitment of patients with metastatic colorectal cancer. The trial, MODULATE, was sponsored by the Australasian Gastro-Intestinal Trials Group and supported by Bristol-Myers Squibb. It was conducted at 16 clinical oncology sites around Australia. Data communicated to Bionomics from the Sponsor suggest that the combination treatment of BNC105 and nivolumab was well-tolerated and demonstrated some anti-tumour activity with encouraging increases in Overall Survival but did not meet the high hurdle of the anticipated Response Rate in this small cohort of patients. Ongoing ex-vivo studies are examining the impact of the treatment combination on the tumour microenvironment.
Financing Activities