Neuphoria Therapeutics Inc 6-K, filed Mar 15, 2024
Neuphoria Therapeutics Inc. (NEUP)
About this 6-K
Neuphoria Therapeutics Inc filed this 6-K on March 15, 2024.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
OF THE SECURITIES EXCHANGE ACT OF 1934
For the month of March, 2024
(Commission File No. 001-41157)
BIONOMICS LIMITED
(Translation of registrant’s name into English)
200 Greenhill Road
Eastwood SA 5063
Tel: +618 8150 7400]
(Address of registrant’s principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101 (b) (1):
Yes ☐ No ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101 (b) (7):
Yes ☐ No ☐
Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes ☐ No ☐
INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K
On March 15 2024, Bionomics Limited (the “Company”) lodged with the Australian Securities and Investments Commission (ASIC), as required by the laws and regulations of Australia, "Bionomics Limited Half-Year Financial Report- December 31, 2023". The Report is furnished herewith as Exhibit 99.1 to this report on Form 6-K.
1
EXHIBIT INDEX
|
|
Exhibit
|
Description
|
99.1 |
Bionomics Limited - Half Year Financial Report 31 December 2023 |
|
|
2
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereto duly authorized.
|
|
|
|
Bionomics Limited |
|
|
(Registrant) |
|
|
|
|
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By: |
/s/ Spyros Papapetropoulos
|
|
Name: |
Spyros Papapetropoulos, MD Ph.D. |
|
Title: |
President & CEO |
Date: March 15, 2024
3
Exhibit 99.1
ABN 53 075 582 740
BIONOMICS LIMITED
Half-Year Report – 31 December 2023
Contents |
Page |
|
2 |
Auditor’s Independence Declaration |
8 |
Consolidated Statement of Profit or Loss and Other Comprehensive Income |
9 |
|
10 |
|
11 |
|
12 |
Notes to the Consolidated Financial Statements |
13 |
|
19 |
|
20 |
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 2023.
Page 1 of NUMPAGES 18
Exhibit 99.1
BIONOMICS LIMITED
Directors’ Report
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 2023. To comply with the provisions of the Corporations Act 2001, the Directors' report is as follows:
Directors
The names of the Directors of the Company during or since the end of the half-year:
Principal Activities
The group's principal activities during the period include developing novel drug candidates focused on treating central nervous system disorders (CNS).
Dividends
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 2023, decreased by $3,383,992 to $14,866,263 at 31 December 2023, from $18,250,255 at 30 June 2023. The decrease is due to net decrease in cash from activities during the half-year ended 31 December 2023 of $3,015,862 and a foreign exchange loss from the effects of exchange rate changes on the balance of cash held in foreign currencies at 31 December 2023 of $368,130. The net decrease in cash from activities is due to the following:
Offset by
The operating loss after tax for the half-year ended 31 December 2023 decreased to $15,368,459, compared to $16,207,967 for the half-year ended 31 December 2022, primarily as a result of:
Page 2 of NUMPAGES 18
Exhibit 99.1
Offset by:
Offset by:
Page 3 of NUMPAGES 18
Exhibit 99.1
Offset by
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 signaling in the brain. The α7 nicotinic acetylcholine ("nACh") receptor ("α7 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 α7 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 and the 2nd generation α7 receptor NAM program. The Company is seeking funding and 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 α7 receptor for the acute treatment of SAD and chronic treatment of PTSD.
In December 2022, the Company completed its Phase 2 PREVAIL Study (NCT05193409) to evaluate BNC210 for the acute treatment of SAD. The PREVAIL Study was 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 PREVAIL data will support the progression of BNC210 into Phase 3. On 13 September 2023, an End-of-Phase 2 meeting was held with the US Food and Drug Administration (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. Following what the company believes was a successful End-of-Phase 2 meeting and the written comments received by the FDA following the 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.
On 27 September 2023, the company also announced 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, randomised 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-5 score 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-Åsberg 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 favourable 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
Page 4 of NUMPAGES 18
Exhibit 99.1
abnormal results were not associated with hepatic injury and in most cases were resolved without drug discontinuation. The Company plans to engage with the FDA to discuss the registrational path for BNC210 in PTSD.
The company has also identified several leads for a 2nd generation of an oral, proprietary selective NAM of the α7 receptor. The leads have the potential to offer significant advantages over BNC210 in terms of in vitro potency, in vivo efficacy and solubility with excellent selectivity. With the necessary resources, contingent upon securing funds, we anticipate nominating a development candidate within the next 12-18 months to initiate IND-enabling studies. These 2nd generation compounds, if successful, may enhance the company’s ability for life-cycle management and exclusivity of the α7 receptor program.
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 α7 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 α7 Receptor PAM targeting cognitive dysfunction associated with Alzheimer’s disease and other CNS conditions.
MSD funds all research and clinical development, and worldwide commercialisation 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 α7 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 α7 nAChR PAMs in humans. In addition to MK-4334 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 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 tumors 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
Page 5 of NUMPAGES 18
Exhibit 99.1
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.
Near-term Outlook
Bionomics remains focused on developing its ongoing clinical programs with BNC210 in SAD and PTSD. Bionomics is currently continuing 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 the program. Bionomics is also preparing for regulatory interactions to discuss next steps in the PTSD development program and plans to engage with the FDA in the upcoming months.
Financing Activities
During September 2023 and December 2023 Cantor (who act as the Company’s sales agent) sold under the US ATM Program, 2,533,739 ADSs (456,073,020 ordinary shares) raising gross proceeds of US$7,333,334 ($10,519,012). The net proceeds raised was $10,461,452 after deduction costs associated with the share issue of $965,246.
Since 31 December 2023 and up to the date of this report
The net proceeds of the share issues, along with the existing cash and cash equivalents, are primarily being used to advance BNC210 through to the initiation and completion of the planned Phase 3 study in SAD, the evaluation of next development steps of BNC210 in PTSD, and for working capital for other research and development activities and general corporate purposes. Management continues to evaluate our capital requirements based on assumed activities and forecast expenditures.
Subsequent Events
Details about subsequent events are disclosed in Note 13 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 8.
Page 6 of NUMPAGES 18
Exhibit 99.1
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
President, Chief Executive Officer and Director
Dated at Adelaide this 15 March 2024
Page 7 of NUMPAGES 18
|
Ernst & Young Adelaide SA 5000 Australia GPO Box 1271 Adelaide SA 5001 |
Tel: +61 8 8417 1600 Fax: +61 8 8417 1775 ey.com/au |
Auditor’s independence declaration to the directors of Bionomics Limited
As lead auditor for the review of the half‑year financial report of Bionomics Limited for the half‑year ended 31 December 2023, I declare to the best of my knowledge and belief, there have been:
This declaration is in respect of Bionomics Limited and the entities it controlled during the financial period.
Ernst & Young
Nigel Stevenson
Partner
15 March 2024
A member firm of Ernst & Young Global Limited
Liability limited by a scheme approved under Professional Standards Legislation
Page 8 of 21
BIONOMICS LIMITED
Consolidated Statement of Profit or Loss and Other Comprehensive Income
for the half-year ended 31 December 2023
|
|
Half-year ended |
||
|
Note |
31 Dec 2023 |
|
31 Dec 2022 |
|
|
$ |
|
$ |
|
|
|
|
|
Continuing operations |
|
|
|
|
Interest income |
|
216,346 |
|
192,270 |
Other income |
2 |
145,159 |
|
132,784 |
Other gains and (losses) |
2 |
(478,155) |
|
414,442 |
|
|
|
|
|
Expenses |
|
|
|
|
Research and development expenses |
|
(7,729,756) |
|
(10,760,153) |
Administration expenses |
|
(6,044,654) |
|
(4,081,012) |
Occupancy expenses |
|
(111,936) |
|
(111,149) |
Compliance expenses |
|
(1,454,552) |
|
(2,083,933) |
Finance expenses |
3 |
(17,546) |
|
(15,139) |
(Loss) before tax |
|
(15,475,084) |
|
(16,311,890) |
|
|
|
|
|
Income tax benefit |
|
106,625 |
|
103,933 |
|
|
|
|
|
(Loss) for the period |
|
(15,368,459) |
|
(16,207,967) |
|
|
|
|
|
Other comprehensive income, net of income tax |
|
|
|
|
Items that may be reclassified subsequently to profit or loss: |
|
|
|
|
(Loss)/Gain on exchange differences from translating foreign operations |
|
(214,434) |
|
199,913 |
|
|
|
|
|
Total comprehensive (Loss) for the period |
|
(15,582,893) |
|
(16,008,054) |
(Loss) per share from continuing operations: |
|
Cents |
|
Cents |
|
|
|
|
|
Basic (loss) per share |
|
(0.9) |
|
(1.2) |
Diluted (loss) per share |
|
(0.9) |
|
(1.2) |
The above consolidated statement of profit or loss and other comprehensive income should be read in conjunction with the accompanying notes.
Page 9 of 21
BIONOMICS LIMITED
Consolidated Statement of Financial Position
as at 31 December 2023
|
Note |
31 Dec 2023 $ |
30 June 2023 $ |
CURRENT ASSETS |
|
|
|
|
|
|
|
Cash and cash equivalents |
|
14,866,263 |
18,250,255 |
Trade and other receivables |
5(b) |
475,870 |
14,718 |
Research and development incentives receivable |
|
145,159 |
627,559 |
Prepayments |
|
1,368,711 |
1,203,214 |
TOTAL CURRENT ASSETS |
|
16,856,003 |
20,095,746 |
|
|
|
|
NON-CURRENT ASSETS |
|
|
|
|
|
|
|
Property, plant and equipment |
|
3,114 |
3,804 |
Right-of-use assets |
|
413,008 |
498,458 |
Goodwill |
|
12,948,663 |
13,084,300 |
Other intangible assets |
12 |
8,512,766 |
9,202,594 |
Other financial assets |
|
119,000 |
119,000 |
TOTAL NON-CURRENT ASSETS |
|
21,996,551 |
22,908,156 |
|
|
|
|
TOTAL ASSETS |
|
38,852,554 |
43,003,902 |
|
|
|
|
CURRENT LIABILITIES |
|
|
|
|
|
|
|
Trade and other payables |
|
2,563,168 |
3,500,487 |
Lease liabilities |
|
176,669 |
171,841 |
Other borrowings |
4 |
1,122,708 |
- |
Provisions |
|
560,588 |
457,017 |
TOTAL CURRENT LIABILITIES |
|
4,423,133 |
4,129,345 |
|
|
|
|
NON-CURRENT LIABILITIES |
|
|
|
|
|
|
|
Lease liabilities |
|
272,139 |
361,742 |
Provisions |
|
1,872 |
22,398 |
Deferred tax liabilities |
|
1,516,630 |
1,655,369 |
Contingent consideration |
11 |
3,605,699 |
3,687,189 |
TOTAL NON-CURRENT LIABILITIES |
|
5,396,340 |
5,726,698 |
|
|
|
|
TOTAL LIABILITIES |
|
9,819,473 |
9,856,043 |
|
|
|
|
NET ASSETS |
|
29,033,081 |
33,147,859 |
|
|
|
|
EQUITY |
|
|
|
|
|
|
|
Issued capital |
5(a) |
233,823,665 |
223,412,662 |
Reserves |
|
13,835,261 |
14,505,746 |
Accumulated losses |
|
(218,625,845) |
(204,770,549) |
Total equity |
|
29,033,081 |
33,147,859 |
|
|
|
|
The above consolidated statement of financial position should be read in conjunction with the accompanying notes.
Page 10 of 21
BIONOMICS LIMITED
Consolidated Statement of Changes in Equity
for the half-year ended 31 December 2023
|
Issued Capital |
Foreign currency translation reserve |
Share- based payments reserve |
Accumulated losses |
Total |
|
$ |
$ |
$ |
$ |
$ |
Balance 1 July 2022 |
217,695,759 |
6,186,333 |
6,337,264 |
(173,306,503) |
56,912,853 |
Loss for the period |
- |
- |
- |
(16,207,967) |
(16,207,967) |
Gain on exchange differences from translating foreign operations |
- |
199,913 |
- |
- |
199,913 |
Total comprehensive income for the period |
- |
199,913 |
- |
(16,207,967) |
(16,008,054) |
Share placement as reuslt of US F-1 |
7,419,235 |
- |
- |
- |
7,419,235 |
Cost associated with share issue |
(1,613,067) |
- |
- |
- |
(1,613,067) |
Recognition of share-based payments |
- |
- |
1,008,431 |
- |
1,008,431 |
Transfer of lapsed share options and warrants |
- |
- |
(285,695) |
285,695 |
- |
Balance at 31 December 2022 |
223,501,927 |
6,386,246 |
7,060,000 |
(189,228,775) |
47,719,398 |
|
|
|
|
|
|
|
|
|
|
|
|
Balance at 1 July 2023 |
223,412,662 |
6,646,840 |
7,858,906 |
(204,770,549) |
33,147,859 |
Loss for the period |
- |
- |
- |
(15,368,459) |
(15,368,459) |
Gain on exchange differences from translating foreign operations |
- |
(214,434) |
- |
- |
(214,434) |
Total comprehensive income for the period |
- |
(214,434) |
- |
(15,368,459) |
(15,582,893) |
Share issues as result of US ATM |
11,426,698 |
- |
- |
- |
11,426,698 |
Cost associated with share issues |
(1,105,695) |
- |
- |
- |
(1,015,695) |
Recognition of share-based payments |
- |
- |
1,057,112 |
- |
1,057,112 |
Transfer of lapsed share options and warrants |
- |
- |
(1,513,163) |
1,513,163 |
- |
Balance at 31 December 2023 |
233,823,665 |
6,432,406 |
7,402,855 |
(218,625,845) |
29,033,081 |
The above consolidated statement of changes in equity should be read in conjunction with the accompanying notes.
Page 11 of 21
BIONOMICS LIMITED
Consolidated Statement of Cash Flows
for the half-year ended 31 December 2023
|
|
Half-year ended |
|
|||
|
|
31 Dec 2023 |
|
|
31 Dec 2022 |
|
|
Note |
$ |
|
|
$ |
|
|
|
|
|
|
|
|
Cash flows from operating activities |
|
|
|
|
|
|
Research and development incentives received |
|
627,559 |
|
|
6,719,761 |
|
Receipts from customers |
|
- |
|
|
- |
|
Payments to suppliers and employees |
|
(14,920,162 |
) |
|
15,713,558 |
) |
Finance costs paid |
|
(14,159 |
) |
|
(15,139 |
) |
|
|
|
|
|
|
|
Net cash (used in) operating activities |
|
(14,306,762 |
) |
|
(9,008,936 |
) |
|
|
|
|
|
|
|
Cash flows from investing activities Interest received |
|
213,827 |
|
|
191,100 |
|
|
|
|
|
|
|
|
Net cash generated by investing activities |
|
213,827 |
|
|
191,100 |
|
|
|
|
|
|
|
|
Cash flows from financing activities |
|
|
|
|
|
|
Proceeds from share issues |
|
10,957,315 |
|
|
7,419,235 |
|
Proceeds from other borrowings |
|
1,141,815 |
|
|
- |
|
Payments for share issue costs |
|
(937,282 |
) |
|
(1,385,746 |
) |
Principal elements of lease payments |
|
(84,775 |
) |
|
(79,077 |
) |
|
|
|
|
|
|
|
Net cash generated by financing activities |
|
11,077,073 |
|
|
5,954,412 |
|
|
|
|
|
|
|
|
Net (decrease) in cash and cash equivalents |
|
(3,015,862 |
) |
|
(2,863,424 |
) |
|
|
|
|
|
|
|
Cash and cash equivalents at the beginning of the half-year |
|
18,250,255 |
|
|
33,564,857 |
|
Effects of exchange rate changes on the balance of cash held in foreign currencies |
|
(368,130 |
) |
|
(3,071 |
) |
Cash and cash equivalents at the end of the half-year |
10 |
14,866,263 |
|
|
30,698,362 |
|
The above consolidated statement of cash flows should be read in conjunction with the accompanying notes.
Page 12 of 21
BIONOMICS LIMITED
Notes to the Consolidated Financial Statements
for the half-year ended 31 December 2023
NOTE 1: Summary of significant accounting policies
The half-year financial report is a general-purpose financial report prepared in accordance with the Corporations Act 2001and AASB 134 ‘Interim Financial Reporting’. Compliance with AASB 134 ensures compliance with International Financial Reporting Standard IAS 34 ‘Interim Financial Reporting’. The half-year report does not include notes of the type normally included in an annual financial report and should be read in conjunction with the most recent annual financial report.
The consolidated financial statements have been prepared on the basis of historical cost, except for the contingent consideration liability which is measured at fair value at the end of each reporting period (Note 11). Cost is based on the fair values of the consideration given in exchange for assets. All amounts are presented in Australian dollars, unless otherwise noted.
The accounting policies and methods of computation adopted in the preparation of the half-year financial report are consistent with those adopted and disclosed in the Company’s annual financial report for the financial year ended 30 June 2023 except for the impact of the Standards and Interpretations described below. These accounting policies are consistent with Australian Accounting Standards (AAS) and with International Financial Reporting Standards (IFRS).
The Group has adopted all the new and revised Standards and Interpretations issued by the Australian Accounting Standards Board (the AASB) that are relevant to its operations and effective for an accounting period that begins on or after 1 July 2023. The adoption of all the new and revised Standards and Interpretations has not resulted in any significant changes to the Group’s accounting policies and has no material effect on the amounts reported for the current or prior half-years..
NOTE 2: other income and other gains and losses
|
Half-year ended |
|
|
31 Dec 2023 |
31 Dec 2022 |
Other income from continuing operations |
$ |
$ |
Government Research and Development Incentives (i) |
145,159 |
132,784 |
|
Half-year ended |
|
|
31 Dec 2023 |
31 Dec 2022 |
Other gains and (losses) from continuing operations |
$ |
$ |
Net gain/(loss) arising on changes in fair value of contingent consideration (Note 11) |
81,490 |
(39,507) |
Net realised and unrealised foreign currency gain/(loss) |
(559,645) |
453,949 |
|
(478,155) |
414,442 |
Page 13 of 21
BIONOMICS LIMITED
Notes to the Consolidated Financial Statements
for the half-year ended 31 December 2023
NOTE 3: Finance Expense
|
Half-year ended |
|
|
31 Dec 2023 |
31 Dec 2022 |
|
$ |
$ |
Interest expense on lease liabilities |
8,606 |
11.335 |
Interest expenses on other borrowings |
3,377 |
- |
Bank fees |
5,553 |
3,804 |
|
17,536 |
15,139 |
NOTE 4: Other borrowings
During December 2023, the Company entered into an agreement with the Company’s insurance broker for the D&O insurance premium that will be paid over a 10-month period at an interest rate of 6.88%.
The amount financed is US$764,758 ($1,141,815) and the monthly repayment is US$78,911, with the first payment commencing during the month of January 2024.
NOTE 5(a): Equity Securities Issued
|
Half-year ended |
|
Half-year ended |
||||||
|
31 Dec 2023 |
|
31 Dec 2022 |
|
31 Dec 2023 |
|
31 Dec 2022 |
||
|
Number of shares |
|
Number of shares |
|
$ |
|
$ |
||
Ordinary shares |
|
|
|
|
|
|
|
||
Balance at the beginning of the half-year |
1,468,735,424 |
|
1,353,350,744 |
|
223,412,662 |
|
217,695,759 |
||
Issue of shares under the US ATM |
456,073,020 |
|
- |
|
11,426,698 |
|
- |
||
Issue of shares US F-1 |
- |
|
115,384,680 |
|
- |
|
7,419,235 |
||
Costs associated with share issues |
- |
|
- |
|
(1,015,695) |
|
(1,613,067) |
||
Total Issued Capital |
1,924,808,444 |
|
1,468,735,424 |
|
233,823,665 |
|
223,501,927 |
||
During the half-year ended 31 December 2023 the following shares were issued under the US ATM programme in which Cantor acted as the sales agent:
Month |
Number of ADSs |
Number of shares |
Proceeds $ |
September 2023 |
2,100,866 |
378,155,880 |
10,519,013 |
December 2023 |
432,873 |
77,917,140 |
907,685 |
|
2,533,739 |
456,073,020 |
11,426,698 |
The proceeds for the last share issue in December, which occurred on 28 December 2023, $469,383 (US$320,766), was received on 2 January 2024. After deduction of commission of $14,081 (US$9,623) the net proceeds received was $455,301 (USD 311,143). As at 31 December 2023 the
Page 14 of 21
BIONOMICS LIMITED
Notes to the Consolidated Financial Statements
for the half-year ended 31 December 2023
net proceeds is included in trade and other receivables in the Consolidated Statement of Financial Position, see Note 5(b), below.
NOTE 5(b): TRADE AND OTHER RECEIVABLES
|
Half-year ended |
|
|
31 Dec 2023 |
31 Dec 2022 |
|
$ |
$ |
Net proceeds receivable from share issue, see Note 5(a) |
455,301 |
- |
GST receivables |
20,569 |
14,718 |
|
475,870 |
14,718 |
NOTE 6: share options and Warrants
During the half-year ended 31 December 2023, no share options or warrants were exercised.
During the half-year ended 31 December 2023, 6,447,385 share options lapsed or cancelled, details are set out below:
Number of share options |
Exercise price |
5,000,000 |
$0.0520 |
839,385 |
$0.0965 |
4,000 |
$0.2327 |
200,000 |
$0.2349 |
200,000 |
$0.2866 |
5,000 |
$0.3556 |
15,000 |
$0.4077 |
10,000 |
$0.4136 |
5,000 |
$0.4311 |
50,000 |
$0.4838 |
100,000 |
$0.5125 |
15,000 |
$0.5750 |
4,000 |
$0.6611 |
6,447,385 |
|
During the half-year ended 31 December 2023, warrants outstanding as at 30 June 2023 (142,000,000) with an exercise price of $0.06 lapsed.
NOTE 7: Change in Accounting Estimates
There has been no material changes in the basis of accounting estimates since the last annual reporting date.
NOTE 8: Contingencies and Commitments
There has been no change in contingent liabilities and commitments since the last annual reporting date.
Page 15 of 21
BIONOMICS LIMITED
Notes to the Consolidated Financial Statements
for the half-year ended 31 December 2023
NOTE 9: related PARTY TRANSACTIONS
The following options were cancelled:
Number of share options |
Vesting date |
Exercise price |
5,000,000 |
30-Jun 24 |
$0.0520 |
839,385 |
31-Dec-25 |
$0.0965 |
The vesting date of the following options were changed:
Number of share options |
Previous Vesting date |
New vesting date |
Exercise price |
Expiry date |
2,986,663 |
31-Mar-24 |
30-Sep-23 |
$0.2014 |
31-Mar-24 |
2,986,663 |
30-Jun-24 |
30-Sep-23 |
$0.2014 |
30-Jun-24 |
2,986,663 |
30-Sep-24 |
30-Sep-23 |
$0.2014 |
30-Jun-24 |
2,986,663 |
31-Dec-24 |
30-Sep-23 |
$0.2014 |
31-Dec-29 |
2,986,663 |
31-Mar-25 |
30-Sep-23 |
$0.2014 |
31-Mar-30 |
2,986,663 |
30-Jun-25 |
30-Sep-23 |
$0.2014 |
30-Jun-30 |
839,385 |
31-Mar-24 |
30-Sep-23 |
$0.965 |
31-Mar-29 |
839,385 |
30-Jun-24 |
30-Sep-23 |
$0.965 |
30-Jun-29 |
839,385 |
30-Sep-24 |
30-Sep-23 |
$0.965 |
30-Sep-29 |
839,385 |
31-Dec-24 |
30-Sep-23 |
$0.965 |
31-Dec-29 |
839,385 |
31-Mar-25 |
30-Sep-23 |
$0.965 |
31-Mar-30 |
839,385 |
30-Jun-25 |
30-Sep-23 |
$0.965 |
30-Jun-30 |
839,385 |
30-Sep-25 |
30-Sep-23 |
$0.965 |
30-Sep-30 |
NOTE 10: CASH FLOW INFORMATION
Cash and cash equivalents
Page 16 of 21
BIONOMICS LIMITED
Notes to the Consolidated Financial Statements
for the half-year ended 31 December 2023
|
Half-year ended |
|
|
31 Dec 2023 |
31 Dec 2022 |
|
$ |
$ |
Cash and bank balances |
14,866,263 |
30,698,362 |
NOTE 11: FAIR VALUE OF FINANCIAL INSTRUMENTS
The Group has no financial assets that are measured at fair value and the only financial liability that is measured at fair value is Contingent Consideration. The following table gives information about how the fair value of this financial liability is determined:
|
Fair Value as at |
|
|
|
|
|
Financial Liabilities |
31 December 2023 $ |
30 June 2023 $ |
Fair value hierarchy |
Valuation technique |
Significant unobservable inputs |
Relationship of unobservable inputs to fair value |
Contingent consideration |
3,605,699 |
3,687,189 |
Level 3 |
Discounted cash flow |
Discount rate of 25% (pre-tax) applied to milestone and royalty projections, probability adjusted revenue projections. |
The higher the discount rate, the lower the value. The higher the possible revenue, the higher value. |
The carrying value of all other financial assets and liabilities approximate their fair value.
Contingent Consideration
During the year ended 30 June 2013, the Company acquired Eclipse Therapeutics, Inc (Eclipse) into its wholly owned subsidiary Bionomics, Inc. Part of the consideration are potential cash earn-outs to Eclipse security holders based on achieving late-stage development success or partnering outcomes of the Eclipse asset that was acquired. This liability is recorded at fair value; information about the calculation of the fair value is set out above. Due to changes in the projected inputs, being the timing and quantum of expected cash outflow at 31 December 2023 the liability has decreased by $81,490 from the 30 June 2023 balance.
Reconciliation of Level 3 Fair Value Measurements
|
Half-year ended |
|
|
Contingent consideration |
|
|
31 Dec 2023 |
31 Dec 2022 |
|
$ |
$ |
Opening balance |
3,687,189 |
2,699,010 |
Total (gain)/loss recognised under “other gains or (losses)” in the Statement of Profit or Loss and Other Comprehensive Income |
(81,490) |
39,507 |
Page 17 of 21
BIONOMICS LIMITED
Notes to the Consolidated Financial Statements
for the half-year ended 31 December 2023
Closing balance |
3,605,699 |
2,738,517 |
NOTE 12: OTHER INTANGIBLE ASSETS
For the year ended 30 June 2023 “other intangible assets” included MultiCore technology, KV1.3 and VDA compounds which were fully amortised (resulting in a nil value for each of these intangible assets). As at 31 December 2023 these intangible assets have been derecognised as no future economic benefits are expected from their use or disposal.
NOTE 13: SUBSEQUENT EVENTS
Since 31 December 2023 and up to the date of this report
NOTE 14: Segment Information
The Group operates in one segment being “drug development” in Australia. This is the basis on which its internal reports are reviewed and used by the Board of Directors (the “chief operating decision maker”) in monitoring, assessing performance and in determining the allocation of resources.
The results, assets and liabilities from this segment are equivalent to the consolidated financial statements.
Page 18 of 21
BIONOMICS LIMITED
Directors’ Declaration
In accordance with a resolution of the Directors of Bionomics Limited, I state that:
In the opinion of the Directors:
and of its performance for the half-year ended on that date; and
On behalf of the Directors
Spyridon “Spyros” Papapetropoulos |
|
President, Chief Executive Officer and Director |
|
Adelaide, 15 March 2024
Page 19 of 21
|
Ernst & Young 121 King William Street Adelaide SA 5000 Australia GPO Box 1271 Adelaide SA 5001 |
Tel: +61 8 8417 1600 Fax: +61 8 8417 1775 ey.com/au |
Independent auditor’s review report to the members of Bionomics Limited
Report on the half‑year financial report
Conclusion
We have reviewed the accompanying half‑year financial report of Bionomics Limited (the Company) and its subsidiaries (collectively the Group), which comprises the consolidated statement of financial position as at 31 December 2023, the consolidated statement of profit or loss and other comprehensive income, consolidated statement of changes in equity and consolidated statement of cash flows for the half‑year ended on that date, notes comprising a summary of significant accounting policies and other explanatory information, and the directors’ declaration.
Based on our review, which is not an audit, nothing has come to our attention that causes us to believe that the half‑year financial report of the Group is not in accordance with the Corporations Act 2001, including:
Basis for conclusion
We conducted our review in accordance with ASRE 2410 Review of a Financial Report Performed by the Independent Auditor of the Entity (ASRE 2410). Our responsibilities are further described in the Auditor’s responsibilities for the review of the half-year financial report section of our report. We are independent of the Group in accordance with the auditor independence requirements of the Corporations Act 2001 and the ethical requirements of the Accounting Professional and Ethical Standards Board’s APES 110 Code of Ethics for Professional Accountants (including Independence Standards) (the Code) that are relevant to our audit of the annual financial report in Australia. We have also fulfilled our other ethical responsibilities in accordance with the Code.
Directors’ responsibilities for the half‑year financial report
The directors of the Company are responsible for the preparation of the half‑year financial report that gives a true and fair view in accordance with Australian Accounting Standards and the Corporations Act 2001 and for such internal control as the directors determine is necessary to enable the preparation of the half‑year financial report that is free from material misstatement, whether due to fraud or error.
Auditor’s responsibilities for the review of the half-year financial report
Our responsibility is to express a conclusion on the half-year financial report based on our review. ASRE 2410 requires us to conclude whether we have become aware of any matter that makes us believe that the half-year financial report is not in accordance with the Corporations Act 2001
A member firm of Ernst & Young Global Limited
Liability limited by a scheme approved under Professional Standards Legislation
Page 20 of 21
|
|
|
including giving a true and fair view of the Group’s financial position as at 31 December 2022 and its performance for the half-year ended on that date, and complying with Accounting Standard AASB 134 Interim Financial Reporting and the Corporations Regulations 2001.
A review of a half‑year financial report consists of making enquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review is substantially less in scope than an audit conducted in accordance with Australian Auditing Standards and consequently does not enable us to obtain assurance that we would become aware of all significant matters that might be identified in an audit. Accordingly, we do not express an audit
opinion.
Ernst & Young
Nigel Stevenson
Partner
15 March 2024
Page 21 of 21