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ABN 53 075 582 740 BIONOMICS LIMITED ASX half-year information – 31 December 2022 Lodged with the ASX under Listing Rule 4.2A Contents Page Results for Announcement to the Market 2 Announcement 3 Half-year Report

Key Takeaway: Bionomics Limited reported its half-year results for FY2023, indicating an increased net loss and decreased cash reserves compared to the previous year. Despite challenges, including missing a primary endpoint in the PREVAIL Study for Social Anxiety Disorder, the company noted progress in pipeline development and ongoing partnerships. Additionally, Bionomics is advancing its research in Alzheimer's disease with Merck & Co. and has upcoming topline results expected for the ATTUNE study in mid-2023. The leadership team has also seen a change with the appointment of a new CEO.

Market Sentiment Analysis

POSITIVE FACTORS

  • Bionomics made progress in advancing its pipeline, including a Phase 2 study.
  • The company is implementing strategic corporate initiatives for long-term shareholder value.
  • Safety review of ongoing studies has not reported any concerns.

CONCERNS & RISKS

  • Net loss increased significantly from $13,154,741 to $16,207,967.
  • Cash and cash equivalents decreased by 8.5% during the half-year.
  • Net financing cash inflows dropped substantially by 75.8%.
  • The primary endpoint of the PREVAIL Study was not met, indicating challenges in drug efficacy.

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 5
Half-year ended 31 December 2022
(Previous corresponding period: Half-year ended 31 December 2021)
Results for announcement to the market
$
Cash and cash equivalents at 31 December 2022 from 30 June 2022 decreased by $2,866,495 (8.5%) to 30,698,362
Net operating cash outflows for the period decreased by $3,830,223 (29.8%) to 9,008,936
Net investing cash inflows for the period decreased by $423,215 (68.9%) to 191,100
Net financing cash inflows for the period decreased by $18,620,454 (75.8%) to 5,954,412
Loss for the half-year before income tax from continuing operations increased by $3,163,329 (24.1%) to 16,311,890
Loss for the half-year after tax increased by $3,154,226 (24.2%) to 16,207,967
Explanation of cash and cash equivalents position as of 31 December 2022
Closing cash and cash equivalents are in line with expectations, with net funds raised through share issues used to continue to progress the BNC210 development and pay the operating expenditure.
Explanation of operating outflows
Net cash outflows from operating activities decreased during the period due to receiving research and development incentives for the years ended 30 June 2021, and 2022, during the half-year that ended 31 December 2022, as the Company lodged the claim for the year ended 30 June 2021, during June 2022 and the claim for the year ended 30 June 2022, during September 2022, offset by an increase in payments to suppliers and employees, due to increased activities.
Explanation of net investment inflows
Net cash inflows from investing activities decreased during the period due to a decrease in proceeds from other financial assets (term deposits) and the sale of plant and equipment offset by an increase in interest received.
Explanation of net financing inflows
Net cash inflows from financing activities decreased during the period as a result of a decrease in net proceeds from share issues received offset by a decrease in principal element of lease repayments.
Explanation of net loss from ordinary activities after tax
The increase in half-year loss principally reflects an increase in research and development expenses, and compliance expenses, offset by an increase in realised and unrealised foreign exchange gain and a decrease in administrative expenses.
Dividends/distributions
Bionomics Limited does not propose to pay any dividends for the half-year ended 31 December 2022.
Half-year
31 December 2022 31 December 2021
Net tangible asset backing per ordinary share 2.02 cents 2.90 cents
BIONOMICS' HALF-YEAR REPORT
Adelaide, Australia: Bionomics Limited (ASX: BNO, NASDAQ: BNOX), today announced its FY2023 report for the half-year ended 31 December 2022. This period represented a transformational time for Bionomics in which the Company made great strides on multiple fronts, including progress on advancing the pipeline, raising capital, and implementing strategic corporate initiatives designed to create long-term shareholder value.
The Company recently completed its Phase 2 PREVAIL Study to evaluate BNC210 for the acute treatment of Social Anxiety Disorder (SAD). The PREVAIL Study, initiated in January 2022, was a randomised, double-blind, placebo-controlled, multi-center Phase 2 clinical trial with a single dose treatment conducted at 15 sites in the US and recruited approximately 150 patients with SAD. The PREVAIL Study completed recruitment, and topline data were reported on 19 December 2022. The Company announced that 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 did 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 its analysis of the PREVAIL dataset and is assessing the next steps for the development of BNC210 in SAD.
The Company continues to progress evaluation of BNC210 in patients with Post-Traumatic Stress Disorder (PTSD) in a randomised, double-blind, placebo-controlled, multi-center Phase 2b clinical trial with a 12-week treatment period recruiting approximately 200 patients. The ATTUNE study has been ongoing in the US, and new sites were recently opened for recruitment in the United Kingdom. The independent Safety Review Committee meets approximately every three months to monitor participant safety and to date, no safety concerns precluding continuation of the trial have been reported; topline results are expected in mid-2023.
Bionomics also continued to see progress in its 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.
While the internal focus and current research and development spending are restricted to CNS programs, Bionomics continues limited activities to maximise the value of its legacy oncology programs through divestment and/or out-licensing both BNC101 and BNC105. Of the non-core legacy oncology assets, the development program established under the exclusive license agreement of BNC101 to Carina Biotech continued to advance and is projected by Carina to move into the clinic in 1H2023. There is also a Memorandum of Understanding that 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.
In November 2022, the Company issued 614,026 American Depositary Shares ( ADS ) in the United States at a price of US$7.80 per ADS, raising gross proceeds of US$5,000,000 ($7,419,235). The offering price of US$7.80 per ADS ($0.0641 per ordinary share) represented a 1.63% discount to the 15-day volume weighted average price. Each ADS represents 180 fully paid Bionomic ordinary shares and resulted in 115,384,680 fully paid shares being issued. The net proceeds raised were $5,806,168.
In December 2022, the Company announced a critical milestone for the leadership team with the appointment of Dr. Spyridon Spyros Papapetropoulos starting in January 2023 as Bionomics' President, Chief Executive Officer, and Director. In conjunction with this development, it was announced that Dr. Errol De Souza, who had been serving as Bionomics' Executive Chairman since November 2018, would be stepping back from the role and, in 1 January 2023 resumed the role of Non-Executive Chairman of the Board of Directors.
The Company's cash balance as of 31 December 2022 was $30,698,362 (30 June 2022: $35,564,857).
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 2022
Contents Page
Directors' Report 6
Auditor's Independence Declaration 11
Consolidated Statement of Profit or Loss and Other Comprehensive Income 12
Consolidated Statement of Financial Position 13
Consolidated Statement of Changes in Equity 14
Consolidated Statement of Cash Flows 15
Notes to the Consolidated Financial Statements 16
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 2022.
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 that ended 31 December 2022. 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. Alan Fisher, Non-Executive Director
-Mr. David Wilson, Non-Executive Director
-Dr. Jane Ryan, Non-Executive Director
-Mr. Aaron Weaver, Non-Executive Director
-Dr. Miles Davies, Non-Executive Director
-Dr. Spyridon Papapetropoulos, President and Chief Executive Officer
With the appointment of Dr. Spyridon Papapetropoulos on 5 January 2023, as President, Chief Executive Officer and Director, Dr. Errol De Souza resumed the role of non-Executive Chairman from 1 January 2023, previously being the Executive Chairman.
Principal Activities
The group's principal activities during the period include developing novel drug candidates focused on treating central nervous system disorders (CNS).
The Directors do not propose any recommendation for dividends for the current financial year.
REVIEW OF OPERATING RESULTS
Cash during the half-year to 31 December 2022, decreased by $2,866,495 to $30,698,362 at 31 December 2022, from $33,564,857 at 30 June 2022. The decrease is due to net decrease in cash from activities during the half-year ended 31 December 2022 of $2,863,424 and a foreign exchange loss from the effects of exchange rate changes on the balance of cash held in foreign currencies at 31 December 2022 of $3,071. The net decrease in cash from activities is due to the following:
-net cash used in operating activities of $9,008,936, due to payments to suppliers and employees of $15,713,558 and payments for finance costs of $15,139, offset by the receipt of research & development tax incentive of $6,719,761.
-net cash inflows from investing activities of $191,100 due to interest income received; and
-cash inflows from financing activities of $5,954,411, due to net proceeds from share issues of $6,033,489 offset by principal element of lease payments of $79,077.
The operating loss after tax for the half-year ended 31 December 2022 increased to $16,207,967, compared to $13,053,471 for the half-year ended 31 December 2021, primarily as a result of:
-Other income for the half-year increased by $148,062 to $325,054, compared to $176,992 for the previous half-year. The increase is primarily due to an increase in interest income, offset by a decrease in the Australian Government research and development tax incentive income.
-Other gains and (losses) for the half-year increased by $1,081,167 to a net gain of $414,442, compared to a net loss of $666,725 for the previous half-year. The increase is primarily due to favorable movement in foreign exchange rates over the half-year ended 31 December 2022 resulting in a net realised and unrealised foreign currency gain.
-Research and development expenses for the half-year increased by $3,804,879 to $10,760,153, compared to $6,955,274 for the previous half-year, as a result of the ATTUNE Phase 2b PTSD and PREVAIL Phase 2a clinical trials. For the current half-year, there have been two clinical trials compared to one during the previous half-year.
-Administrative expenses for the half-year decreased by $555,728 to $4,081,012, compared to $4,636,740 for the previous half-year, primarily due to:
oa decrease in once-off expenses in the half-year. For the current period, there are none, whereas in the previous period, there were:
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.
oA decrease in the share-based payment expense from amortisation of share options over their vesting period; and
oa decrease in staff and consultant expenses.
oan increase in Executive Chairman's consulting fees due to the transitional payout and bonus payable as a result of the appointment of the new CEO;
oa new expense relating to obtaining assistance with the preparation of our 20F (legal and DFIN (program used to do the 20F)) for lodgment with the SEC in the United States as a result of listing on NASDAQ;
oan increase in staff recruitment expenses; and
oan increase in investor fees.
-Compliance expenses increased by $1,209,902 to $2,083,933 compared to $874,031 for the previous half-year, primarily due to an increase in D&O insurance (as a result of listing on NASDAQ).
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 essential 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 stress- and 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).
The Company recently completed its Phase 2 PREVAIL Study to evaluate BNC210 for the acute treatment of SAD. The PREVAIL Study, initiated in January 2022, was a randomised, double-blind, placebo-controlled, multi-center Phase 2 clinical trial with a single dose treatment conducted at 15 sites in the US and recruited approximately 150 patients with SAD. The PREVAIL Study completed recruitment, and topline data were reported on 19 December 2022. The Company announced that 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 did 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 its analysis of the PREVAIL dataset and is assessing the next steps for the development of BNC210 in SAD.
The Company continues to progress the evaluation of BNC210 in patients with Post-Traumatic Stress Disorder (PTSD) in a randomised, double-blind, placebo-controlled, multi-center Phase 2b clinical trial with a 12-week treatment period recruiting approximately 200 patients. The ATTUNE study has been ongoing in the US, and new sites were recently opened for recruitment in the United Kingdom. The independent Safety Review Committee meets approximately every three months to monitor participant safety with no safety concerns reported precluding continuation of the trial, and topline results are expected in mid-2023.
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$465 million in development and commercialisation milestone payments in addition to royalties from sales of the product(s) which range from mid-single digit to low double digit royalties.
The MSD collaboration currently includes two candidates 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 the 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 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 $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 and plans to commence patient enrollment during the first half of 2023.
Financing Activities
In November 2022 the Company filed a Form F-1 Registration Statement containing a Prospectus for an Offering of American Depositary Shares ( ADS ) in the United States with the Security and Exchange Commission. The Company subsequently issued 614,026 ADS in the United States at a price of US$7.80 per ADS, raising gross proceeds of US$5,000,000 ($7,418,235). The offering price of US$7.80 per ADS ($0.0641 per ordinary share) represented a 1.63% discount to the volume weighted average price for the 15 days ending on 16 November 2022 on which trades of the Company's shares were recorded on the ASX. Each ADS represents 180 fully paid Bionomic ordinary shares and resulted in 115,384,680 fully paid shares being issued. The net proceeds raised were $5,806,168.
The net proceeds of the Offering, along with the existing cash and cash equivalents, are primarily being used to advance BNC210 through to the completion of the ongoing Phase 2b ATTUNE clinical trial, evaluating the next steps for the development of BNC210 in SAD, and for working capital and other research and development and general corporate purposes. Management continues to evaluate our capital requirements based on assumed activities and forecast expenditures.
Details about subsequent events are disclosed in Note 11 to the Half-year Report
auditor's independence declaration
A copy of the auditor's independence declaration, as required under section 307C of the Corporations Act 2001, is set out on page 11.
Signed in accordance with a resolution of the directors made pursuant to section 306(3) of the Corporations Act 2001.
On behalf of the directors
Spyridon Spyros Papapetropoulos

Frequently Asked Questions

What was Bionomics' cash balance at December 31, 2022?

Bionomics' cash balance as of December 31, 2022, was $30,698,362.

Did Bionomics declare a dividend for the half-year ended December 2022?

No, Bionomics did not propose to pay any dividends for the half-year ended December 2022.

What trial did Bionomics complete in December 2022?

Bionomics completed its Phase 2 PREVAIL Study for BNC210 in December 2022.

What was the loss after tax for Bionomics in the half-year?

The loss after tax for Bionomics for the half-year increased to $16,207,967.

Who was appointed CEO of Bionomics in January 2023?

Dr. Spyridon Spyros Papapetropoulos was appointed CEO of Bionomics in January 2023.

Last updated: Feb 23, 2023