10-Q

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 10-Q

(Mark One)


☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2024


☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from _________________ to _________________

Commission File Number: 001-41157

BIONOMICS LIMITED

(Exact Name of Registrant as Specified in its Charter)


Australia		N/A
(State or other jurisdiction of		(I.R.S. Employer
incorporation or organization)		Identification No.)
200 Greenhill Road
Eastwood, SA
Australia		5063
(Address of principal executive offices)		(Zip Code)
+61 8 8150 7400
(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

    Title of each class

    Trading
Symbol(s)

    Name of each exchange on which registered

    American Depositary Shares

    BNOX

    The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.


Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☐	Smaller reporting company	☒
		Emerging growth company	☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court. Yes ☒ No ☐

The American Depositary Shares represent the registrant’s ordinary shares trading on The Nasdaq Global Market, with each ADS representing 180 Ordinary Shares. As of October 31, 2024, the registrant had 3,514,922,864 ordinary shares, no par value per share, issued and outstanding.

Table of Contents


		Page
	Basis of Presentation	ii
	Cautionary Note Regarding Forward-Looking Statements	iii

PART I.	FINANCIAL INFORMATION	1

Item 1.	Financial Statements (Unaudited)	1
	Condensed Consolidated Balance Sheets	1
	Condensed Consolidated Statements of Operations and Other Comprehensive Income (Loss)	2
	Condensed Consolidated Statement of Changes in Shareholders' Equity	3
	Condensed Consolidated Statements of Cash Flows	4
	Notes to Unaudited Condensed Consolidated Financial Statements	5
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	13
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	19
Item 4.	Controls and Procedures	19

PART II.	OTHER INFORMATION	20

Item 1.	Legal Proceedings	20
Item 1A.	Risk Factors	20
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	21
Item 3.	Defaults Upon Senior Securities	21
Item 4.	Mine Safety Disclosures	21
Item 5.	Other Information	21
Item 6.	Exhibits	22
Signatures		24

Basis of Presentation

Bionomics Limited (“Bionomics”) is an Australian company that was incorporated in 1996 and, until June 30, 2024, qualified as a “foreign private issuer” (as defined in Rule 405 under the U.S. Securities Act of 1933). On July 1, 2024, Bionomics began reporting as a domestic issuer under the U.S. Securities Exchange Act of 1934, including the preparation of an annual report on Form 10-K and quarterly reports on Form 10-Q.

Unless otherwise indicated or the context implies otherwise:

•

“we,” “us,” or “our” refers to Bionomics Limited, an Australian corporation, and its consolidated subsidiaries;

•

“shares” or “ordinary shares” refers to our ordinary shares;

•

“ADSs” refers to American Depositary Shares, each of which represents 180 ordinary shares; and

•

“ADRs” refers to American Depositary Receipts, which evidence the ADSs.

We use our registered and unregistered trademarks, including Bionomics™, in this this Quarterly Report on Form 10-Q (the “Quarterly Report”). This Quarterly Report also includes trademarks, tradenames and service marks that are the property of other organizations. Solely for convenience, trademarks and tradenames referred to in this Quarterly Report appear without the ® and ™ symbols, but those references are not intended to indicate in any way that we will not assert, to the fullest extent under applicable law, our rights or that the applicable owner will not assert its rights, to these trademarks and tradenames.

Our reporting and functional currency is currently the U.S. dollar and was previously the Australian dollar. All references to “$” and “US$” in this Quarterly Report mean U.S. dollars. All references to “A$” in this Quarterly Report mean Australian dollars.

Our fiscal year end is June 30. References to a particular “fiscal year” are to our fiscal year ended June 30 of that calendar year.

Unless otherwise indicated, the condensed consolidated financial statements and related notes incorporated by reference in this Quarterly Report have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) and are presented in U.S. dollars.

Certain monetary amounts, percentages and other figures included herein have been subject to rounding adjustments. Accordingly, figures shown as totals in certain tables and charts may not be the arithmetic aggregation of the figures that precede them, and figures expressed as percentages in the text may not total 100% or, as applicable, when aggregated may not be the arithmetic aggregation of the percentages that precede them.

Cautionary Note Regarding Forward-Looking Statements

This report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions intended to identify statements about the future. These statements speak only as of the date of filing this report with the Securities and Exchange Commission (the “SEC”) and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These forward-looking statements include, without limitation, statements about the following:

•

our ability to regain and maintain compliance with the continued listing requirements of The Nasdaq Stock Market LLC (“Nasdaq”);

•

our lack of operating history and need for additional capital;

•

the ability of our clinical trials to demonstrate safety and efficacy of our product candidates and other positive results;

•

the timing and focus of our clinical trials and preclinical studies, and the reporting of data from those trials and studies;

•

our plans relating to commercializing any product candidates, including the geographic areas of focus and sales strategy;

•

the market opportunity and competitive landscape for our product candidates, including our estimates of the number of patients who suffer from the conditions we are targeting;

•

the success of competing therapies that are or may become available;

•

our estimates of the number of patients that we will enroll in our clinical trials;

•

the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates;

•

the timing of initiation and completion, and the progress of our drug discovery and research programs;

•

the timing or likelihood of regulatory filings and approvals for our product candidates for various diseases;

•

our ability to obtain and maintain regulatory approval of our product candidates;

•

our plans relating to the development of our product candidates, including additional indications we may pursue;

•

existing regulations and regulatory developments in the United States, Australia, Europe and other jurisdictions;

•

risks associated with any pandemic that could adversely impact our preclinical studies and clinical trials;

•

our plans and ability to obtain, maintain, protect and enforce our intellectual property rights and our proprietary technologies, including extensions of existing patent terms where available;

•

our continued reliance on third parties to conduct additional clinical trials of our product candidates, and for the manufacture of our product candidates for preclinical studies and clinical trials;

•

our plans regarding any collaboration, licensing or other arrangements that may be necessary or desirable to develop, manufacture or commercialize our product candidates;

•

the need to hire additional personnel and our ability to attract and retain such personnel;

•

our estimates regarding expenses, future revenue, capital requirements, and the impact of a fluctuating currency exchange on these estimates;

•

our financial performance;

•

the period over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure requirements;

•

our anticipated use of our existing resources;

•

cybersecurity risks and any failure to maintain the confidentiality, integrity and availability of our computer hardware, software and internet applications and related tools and functions; and

•

other risks and uncertainties, including those listed under “Risk Factors.”

iii

Other risks and uncertainties are discussed more fully under the caption “Risk Factors” in our filings with the SEC, including in Part I, Item 1A. “Risk Factors” of our Annual Report on Form 10-K for the year ended June 30, 2024 and in Part II, Item 1A. “Risk Factors” of this Quarterly Report on Form 10-Q. Accordingly, you should not place undue reliance on forward-looking statements. To the extent permitted by applicable law, we expressly disclaim any intent or obligation to update any forward-looking statements to reflect subsequent events or circumstances. We operate in an evolving environment and new risk factors and uncertainties may emerge from time to time. As a result of these factors, we cannot assure you that the forward-looking statements in this report will prove to be accurate.

The forward-looking statements contained in this Quarterly Report on Form 10-Q are based on our current expectations and beliefs concerning future developments and their potential effects on us. There can be no assurance that future developments affecting us will be those that we have anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. You should review the factors and risks and other information we describe in the reports we will file from time to time with the SEC. Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respect from those projected in these forward-looking statements. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Although we undertake no obligation to revise or update any forward-looking statements in this Quarterly Report, whether as a result of new information, future events or otherwise, you are advised to consult any additional disclosures that we may make directly to you or through reports that we may file in the future with the SEC, including Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K.

PART I—FINANCIAL INFORMATION

Item 1. Condensed Consolidated Financial Statements.

Bionomics Limited

Condensed Consolidated Balance Sheets (Unaudited)


	September 30,			June 30,
	2024			2024
Assets
Current assets:
Cash and cash equivalents	$	8,082,410		$	12,608,109
Accounts receivable, non-trade		115,960			126,884
Prepaid insurance expense		231,108			458,765
Total current assets		8,429,478			13,193,758
Property and equipment, net		1,964			1,994
Intangible assets, net		5,301,839			5,467,522
Operating lease right-of-use assets		197,447			216,975
Restricted cash		82,491			78,826
Goodwill		8,903,988			8,690,018
Total assets	$	22,917,207		$	27,649,093

Liabilities and Shareholders’ Equity
Current liabilities:
Accounts payable	$	1,325,994		$	2,243,662
Accrued expenses and other current liabilities		1,095,838			1,463,421
Operating lease liability		129,881			121,990
Total current liabilities		2,551,713			3,829,073
Operating lease liability, net of current portion		89,469			117,628
Contingent consideration		679,313			587,762
Deferred tax liability		831,324			963,540
Accompanying warrants liability		1,691,587			4,657,832
Other non-current liabilities		3,437			2,886
Total liabilities		5,846,843			10,158,721
Commitments and contingencies (Note 16)
Shareholders’ equity:
Ordinary shares, no par value; 3,117,662,864 and 2,384,539,964 shares issued and outstanding at September 30, 2024 and June 30, 2024, respectively		-			-
Additional paid-in capital		198,280,436			198,481,038
Accumulated other comprehensive loss, net of tax		(2,428,214	)		(3,013,595	)
Accumulated deficit		(178,781,858	)		(177,977,071	)
Total shareholders’ equity		17,070,364			17,490,372
Total liabilities and shareholders’ equity	$	22,917,207		$	27,649,093

The accompanying notes are an integral part of the unaudited condensed consolidated financial statements.

Bionomics Limited

Condensed Consolidated Statements of Operations and Other Comprehensive Income (Loss) (Unaudited)


	For the three months ended September 30,
	2024			2023
Operating expenses:
Research and development	$	1,900,903		$	3,088,229
General and administrative		1,666,824			2,379,378
Total operating expenses		3,567,727			5,467,607
Loss from operations		(3,567,727	)		(5,467,607	)
Other income (loss):
Interest income, net		36,096			86,439
(Loss) gain on foreign currency translation		(280,037	)		(1,635	)
Gain (loss) on fair value adjustments		2,874,694			(124,558	)
Total other income (loss)		2,630,753			(39,754	)
Loss before income tax expense		(936,974	)		(5,507,361	)
Income tax benefit		132,187			34,793
Net loss		(804,787	)		(5,472,568	)
Other comprehensive loss:
Unrealized gain (loss) on foreign currency translation		585,381			(63,469	)
Total other comprehensive loss:		585,381			(63,469	)
Comprehensive loss	$	(219,406	)	$	(5,536,037	)

Net loss per share —basic and diluted	$	(0.00	)	$	(0.00	)
Weighted-average common shares outstanding—basic and diluted		2,808,140,743			1,495,995,035

The accompanying notes are an integral part of the unaudited condensed consolidated financial statements.

Bionomics Limited

Condensed Consolidated Statement of Changes in Shareholders' Equity (Unaudited)


					Stock			Additional			Accumulated Other						Total
	Ordinary Shares				Subscription			Paid-In			Comprehensive			Accumulated			Shareholders'
	Shares		Amount		Receivable			Capital			Loss			Deficit			Equity
Balance at June 30, 2024		2,384,539,964	$	-	$	-		$	198,481,038		$	(3,013,595	)	$	(177,977,071	)	$	17,490,372
Exercise of pre-funded ADS warrants		733,122,900		-		-			409			-			-			409
Share issue costs		-		-		-			(227,747	)		-			-			(227,747	)
Share-based compensation		-		-		-			26,736			-			-			26,736
Other comprehensive income		-		-		-			-			585,381			-			585,381
Net loss		-		-		-			-			-			(804,787	)		(804,787	)
Balance at September 30, 2024		3,117,662,864	$	-	$	-		$	198,280,436		$	(2,428,214	)	$	(178,781,858	)	$	17,070,364

Balance at June 30, 2023		1,468,735,424	$	-	$	-		$	187,554,251		$	(3,058,783	)	$	(162,484,905	)	$	22,010,563
Issuance of ADS shares, net of issuance costs of $0.5 million		378,155,880		-		(5,648,976	)		6,261,514			-			-			612,538
Share-based compensation		-		-		-			140,448			-			-			140,448
Other comprehensive loss		-		-		-			-			(63,469	)		-			(63,469	)
Net loss		-		-		-			-			-			(5,472,568	)		(5,472,568	)
Balance at September 30, 2023		1,846,891,304	$	-	$	(5,648,976	)	$	193,956,213		$	(3,122,252	)	$	(167,957,473	)	$	17,227,512

The accompanying notes are an integral part of the unaudited condensed consolidated financial statements.

Bionomics Limited

Condensed Consolidated Statements of Cash Flows (Unaudited)


	Three Months Ended September 30,
	2024			2023
Cash flows from operating activities:
Net loss	$	(804,787	)	$	(5,472,568	)
Adjustments to reconcile net loss to net cash used in operating activities:
Share-based compensation		26,736			132,739
Depreciation and amortization expense		165,713			165,909
Non-cash rent expense		19,528			36,166
Change in fair value of accompanying warrant liability		(2,966,245	)		-
Change in fair value of contingent consideration		91,551			124,558
Effect of foreign currency remeasurement		233,044			67,319
Changes in assets and liabilities:
Accounts receivable, non-trade		10,924			(16,252	)
Prepaid insurance expense		227,657			427,316
Accounts payable		(917,668	)		880,613
Accrued expenses and other current liabilities		(367,583	)		(704,745	)
Operating lease liabilities		(20,268	)		(36,393	)
Deferred tax liability		(132,216	)		(34,793	)
Other non-current liabilities		551			331
Net cash used in operating activities		(4,433,063	)		(4,429,800	)
Cash flows from financing activities:
Issue costs associated with ADS shares and ADS pre-funded warrants		(227,747	)		-
Proceeds from the exercise of pre-funded ADS warrants		409			-
Proceeds from the sale of ADS shares, net		-			6,261,514
Stock issued pursuant to a subscription receivable		-			(5,648,976	)
Net cash (used in) provided by financing activities		(227,338	)		612,538
Effect of exchange rate on changes on cash, cash equivalents, and restricted cash		138,367			(152,773	)
Net decrease in cash, cash equivalents, and restricted cash		(4,660,401	)		(3,817,262	)
Cash, cash equivalents, and restricted cash, beginning of period		12,686,935			12,181,944
Cash, cash equivalents, and restricted cash, end of period	$	8,164,901		$	8,211,909

Reconciliation of cash, cash equivalents, and restricted cash:
Cash and cash equivalents	$	8,082,410		$	8,135,059
Restricted cash		82,491			76,850
Total cash, cash equivalents, and restricted cash	$	8,164,901		$	8,211,909

The accompanying notes are an integral part of the unaudited condensed consolidated financial statements.

Bionomics Limited

Notes to Condensed Consolidated Financial Statements

(Unaudited)

Note 1. The Company and Basis of Presentation

Bionomics Limited (“the Company”) is a public company incorporated in Australia. The principal activities of the Company and its controlled entities during the period include the development of novel drug candidates focused on the treatment of serious central nervous system disorders.

Details of the Company’s entity structure at the end of the reporting period are as follows:


Name	Entity	Country of Incorporation
Bionomics Limited	Parent	Australia
Bionomics, Inc.	Subsidiary	United States

Liquidity and Going Concern

As of September 30, 2024, the Company had working capital of $5.9 million, an accumulated deficit of $178.8 million, and cash and cash equivalents of $8.1 million. The Company has not generated any product revenues and has not achieved profitable operations. There is no assurance that profitable operations will ever be achieved, and, if achieved, could be sustained on a continuing basis. In addition, development activities, clinical and non-clinical testing, and commercialization of the Company’s products will require significant additional financing.

The Company is subject to a number of risks similar to other life science companies, including, but not limited to, risks related to the successful discovery, development, and commercialization of product candidates, raising additional capital, development of competing drugs and therapies, protection of proprietary technology, and market acceptance of the Company’s products. As a result of these and other factors and the related uncertainties, there can be no assurance of the Company’s future success.

In accordance with ASC 205-40, Going Concern, the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date these condensed consolidated financial statements are issued. The Company incurred net losses of $0.8 million for the three months ended September 30, 2024 and $15.5 million for the year ended June 30, 2024. The Company also used $4.4 million of cash for operating activities during the three months ended Septembe

SEC Form 10-Q filed by Bionomics Limited