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 October, 2022

(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 October 25, 2022, Bionomics Limited (the “Company”) released its Appendix 4C - Quarterly Cashflow Report for the period ended 30 September 2022 with the Australian Securities Exchange (ASX), as required by the laws and regulations of Australia. The release is furnished herewith as Exhibit 99.1 to this report on Form 6-K.

1

 

EXHIBIT INDEX

 

 

 

Exhibit

 

Description

 

99.1

Quarterly Report for the Period Ended September 2022

 

 

 

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)

 

 

 

 

By:

/s/ Errol De Souza

 

 

Name:

Errol De Souza, Ph.D.

 

Title:

Executive Chairman

Date: October 25, 2022

 

3

Exhibit 99.1

img65882896_0.jpg 

ABN 53 075 582 740

ASX ANNOUNCEMENT

25 October 2022

 

 

Quarterly Activities and Cashflow Report

Bionomics Limited (ASX: BNO, Nasdaq: BNOX), (Bionomics or the Company) 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, today released its Appendix 4C – Quarterly Cashflow Report. Highlights during the Quarter ended 30 September 2022 (Quarter) and up to the date of this announcement include:

•
On 13 July 2022, Bionomics’ Executive Chairman, Dr. Errol De Souza, participated in William Blair’s Biotech Focus Conference 2022 including the “Unmet Needs and Novel Therapies in Neuropsychiatry” panel.
•
On 20 July 2022, Bionomics announced the issue of 7.7 million unlisted options to employees under the Company’s Employee Equity Plan.
•
On 29 July 2022, Bionomics released its Appendix 4C – Quarterly Cashflow Report for the quarter ended 30 June 2022.
•
On 8 August 2022, Bionomics announced the Company had received a $2.1 million Australian Government’s Research and Development (R&D) tax incentive refund relating to the financial year ended 30 June 2021.
•
On 25 August 2022, Bionomics released its Appendix 4E and Full Year Financial Statements for the year ended 30 June 2022.
•
On 21 September 2022, Bionomics announced it would be hosting a Key Opinion Leader (“KOL”) webinar on BNC210, a proprietary, first-in-class oral therapeutic with potential to treat Social Anxiety Disorder (“SAD”) on Wednesday, 12 October 2022, 2:30 – 3:30 pm EDT.

The webinar featured anxiety disorder KOLs Murray B Stein, MD, MPH, FRCPC, and Charles T Taylor, PhD, both from the University of California San Diego, who discussed the unmet medical need and current treatment landscape for SAD patients, as well as Bionomics’ ongoing clinical development and Phase 2 PREVAIL Study paradigm.

•
On 4 October 2022, Bionomics announced that it would be attending the Cantor Neurology & Psychiatry Conference including Bionomics’ Executive Chairman, Dr. Errol De Souza’s participation in the “Emerging Broad Pipeline for Psychiatric Indications Does Not Weigh on Our Minds” panel.
•
On 6 October 2022, the Company filed its 2022 Annual Report.
•
On 6 October 2022, the Company filed its 2022 Corporate Governance Statement and Appendix 4G.
•
On 14 October 2022, Bionomics filed the Notice of Annual General Meeting and Proxy Form.

 

Bionomics Limited | 200 Greenhill Road, South Australia, +61 8 8150 7400, ABN: 53 075 582 740

 

•
On 17 October 2022, Bionomics filed the U.S. Annual Report on Form 20-F with the U.S. Securities and Exchange Commission for the financial year ended 30 June 2022.
•
On 18 October 2022, Bionomics announced the Company had received a $4.6 million Australian Government’s R&D tax incentive refund relating to the financial year ended 30 June 2022.
•
The Company’s cash balance on 30 September 2022 was $31.43 million (30 June 2022: $33.56 million).
•
Payments for research and development expenditure during the Quarter decreased to $3.50 million mainly relating to the ATTUNE and PREVAIL Study expenditures. This represents a decrease of 16.28% from the previous Quarter’s payments of $4.18 million. The ATTUNE Study is evaluating the oral tablet formulation of BNC210 compared to placebo in approximately 200 Post-Traumatic Stress Disorder (“PTSD”) patients in the U.S. The PREVAIL Study is evaluating two doses of the oral tablet formulation of BNC210 compared to placebo as an acute treatment for SAD in approximately 150 patients in the U.S.

 

For the purpose of Listing Rule 4.7C.3, the Executive Chairman was paid during the Quarter $200,000 for consulting fees, $8,000 for reimbursement of health benefit insurance and a $450,000 bonus relating to FY22, in accordance with the consulting agreement, and the other Directors were paid fees of $82,000 during the Quarter.

 

Activity Report

During the quarter, Bionomics continued to closely manage both of its ongoing ATTUNE and PREVAIL clinical studies including over-seeing the recurring Independent Safety Review Committee meetings for the ATTUNE Study and working with the Contract Research Organization (“CRO”) to maximize the ongoing study enrollments. Topline results for the PREVAIL Study are anticipated by year-end 2022, consistent with the Company’s prior guidance.

In anticipation of this, the Company continued to manage its Chemistry Manufacturing and Controls (“CMC”) and toxicology activities related to development of BNC210 for future planned studies.

The Company also remained focused on engaging in a variety of Investor Relations activities including the conferences and KOL webinar highlighted over the Quarter. Furthermore, Bionomics used its KOL webinar to communicate the findings from a U.S. Commercial Market Analysis conducted by Bluestar BioAdvisors for BNC210’s potential in SAD upon reaching commercialization.

Finally, while the Company has sufficient cash runway to complete the ATTUNE and PREVAIL Studies, the Company continues to monitor its expenditures while taking several measures to preserve its cash on hand given the current capital markets landscape.

 

Upcoming Milestones

•
2022 Annual General Meeting on 16 November 2022
•
Topline data for BNC210 PREVAIL study in SAD expected YE’22
•
Topline data for BNC210 ATTUNE study in PTSD expected Mid’23

 

Released on authority of the Board.

 

 

 

 

 

 

 

 

Bionomics Limited | 200 Greenhill Road, South Australia, +61 8 8150 7400, ABN: 53 075 582 740

 

 

 

 

FOR FURTHER INFORMATION PLEASE CONTACT:

 

General:

Ms Suzanne Irwin

Company Secretary

+61 8 8150 7400

CoSec@bionomics.com.au

Investor Relations:

Mr Connor Bernstein

Vice President, Strategy and Corporate Development

+1 (831) 246-3642

cbernstein@bionomics.com.au

 

 

 

 

About Bionomics Limited

Bionomics Limited (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 α7 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.

www.bionomics.com.au

 

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.

 

Bionomics Limited | 200 Greenhill Road, South Australia, +61 8 8150 7400, ABN: 53 075 582 740

 

Rule 4.7B

Appendix 4C

Quarterly cash flow report for entities
subject to Listing Rule 4.7B

Name of entity

Bionomics Limited

ABN

 

Quarter ended (“current quarter”)

53 075 582 740

 

30 September 2022

 

1

Consolidated statement of cash flows

Current quarter

$A’000

Year to date

(3 months)
$A’000

1.

Cash flows from operating activities

 

 

1.1

Receipts from customers

-

-

1.2

Payments for

 

 

 

(a) research and development

(3,502)

(3,502)

 

(b) product manufacturing and operating costs

-

-

 

(c) advertising and marketing

-

-

 

(d) leased assets

-

-

 

(e) staff costs

(391)

(391)

 

(f) administration and corporate costs

(1,494)

(1,494)

1.3

Dividends received (see note 3)

-

-

1.4

Interest received

66

66

1.5

Interest and other costs of finance paid

(7)

(7)

1.6

Income taxes paid

-

-

1.7

Government grants and tax incentives

2,086

2,086

1.8

Other (provide details if material)

-

-

1.9

Net cash from / (used in) operating activities

(3,242)

(3,242)

 

ASX Listing Rules Appendix 4C (17/07/20) Page 1

+ See chapter 19 of the ASX Listing Rules for defined terms.

Appendix 4C

Quarterly cash flow report for entities subject to Listing Rule 4.7B

 

 

 

 

 

1

Consolidated statement of cash flows (continued)

Current quarter

$A’000

Year to date

(3 months)
$A’000

2.

Cash flows from investing activities

 

 

2.1

Payments to acquire or for:

 

 

 

(a) entities

-

-

 

(b) businesses

-

-

 

(c) property, plant and equipment

-

-

 

(d) investments

-

-

 

(e) intellectual property

-

-

 

(f) other non-current assets

-

-

2.2

Proceeds from disposal of:

 

 

 

(a) entities

-

-

 

(b) businesses

-

-

 

(b) property, plant and equipment

-

-

 

(d) investments

-

-

 

(e) intellectual property

-

-

 

(f) other non-current assets

-

-

2.3

Cash flows from loans to other entities

-

-

2.4

Dividends received (see note 3)

-

-

2.5

Other (provide details if material)

-

-

2.6

Net cash from / (used in) investing activities

-

-

 

 

 

 

 

ASX Listing Rules Appendix 4C (17/07/20) Page 2

+ See chapter 19 of the ASX Listing Rules for defined terms.

Appendix 4C

Quarterly cash flow report for entities subject to Listing Rule 4.7B

 

 

1

Consolidated statement of cash flows (continued)

Current quarter

$A’000

Year to date

(3 months)
$A’000

3

Cash flows from financing activities

 

 

3.1

Proceeds from issues of equity securities (excluding convertible debt securities)

-

-

3.2

Proceeds from issue of convertible debt securities

-

-

3.3

Proceeds from exercise of options

-

-

3.4

Transaction costs related to issues of equity securities or convertible debt securities

-

-

3.5

Proceeds from borrowings

-

-

3.6

Principal element of lease payments

(39)

(39)

3.7

Transaction costs related to loans and borrowings

-

-

3.8

Dividends paid

-

-

3.9

Other (provide details if material)

-

-

3.10

Net cash from / (used in) financing activities

(39)

(39)

 

4

Net increase / (decrease) in cash and cash equivalents for the period

 

 

4.1

Cash and cash equivalents at beginning of period

33,565

33,565

4.2

Net cash from / (used in) operating activities (item 1.9 above)

(3.242)

(3,242)

4.3

Net cash from / (used in) investing activities (item 2.6 above)

-

-

4.4

Net cash from / (used in) financing activities (item 3.10 above)

(39)

(39)

4.5

Effect of movement in exchange rates on cash held

1,147

1,147

4.6

Cash and cash equivalents at end of period

31,431

31,431

 

 

 

 

 

ASX Listing Rules Appendix 4C (17/07/20) Page 3

+ See chapter 19 of the ASX Listing Rules for defined terms.

Appendix 4C

Quarterly cash flow report for entities subject to Listing Rule 4.7B

 

5

Reconciliation of cash and cash equivalents
at the end of the quarter (as shown in the consolidated statement of cash flows) to the related items in the accounts

Current quarter
$A’000

Previous quarter
$A’000

5.1

Bank balances

31,431

33,565

5.2

Call deposits

-

-

5.3

Bank overdrafts

-

-

5.4

Other (provide details)

-

-

5.5

Cash and cash equivalents at end of quarter (should equal item 4.6 above)

31,431

35,565

 

6

Payments to related parties of the entity and their associates

Current quarter
$A'000

6.1(a)

Aggregate amount of payments to related parties and their associates included in item 1 (Director fees)

82

6.1(b)

Aggregate amount of payments to related parties and their associates included in item 1 (Executive chairman consulting fee and reimbursement of medical benefit insurance and bonus for the year ended 30 June 2022, as per the Employment Agreement with the Executive Chairman)

658

6.2

Aggregate amount of payments to related parties and their associates included in item 2

-

Note: if any amounts are shown in items 6.1 or 6.2, your quarterly activity report must include a description of, and an explanation for, such payments.

 

 

 

 

 

 

 

7

Financing facilities
Note: the term “facility’ includes all forms of financing arrangements available to the entity.

Add notes as necessary for an understanding of the sources of finance available to the entity.

Total facility amount at quarter end
$A’000

Amount drawn at

quarter end
$A’000

7.1

Loan facilities

-

-

7.2

Credit standby arrangements

-

-

7.3

Other (please specify)

-

-

7.4

Total financing facilities

-

-

 

 

 

7.5

Unused financing facilities available at quarter end

-

7.6

Include in the box below a description of each facility above, including the lender, interest rate, maturity date and whether it is secured or unsecured. If any additional financing facilities have been entered into or are proposed to be entered into after quarter end, include a note providing details of those facilities as well.

 

 

ASX Listing Rules Appendix 4C (17/07/20) Page 4

+ See chapter 19 of the ASX Listing Rules for defined terms.

Appendix 4C

Quarterly cash flow report for entities subject to Listing Rule 4.7B

 

 

8

Estimated cash available for future operating activities

$A’000

8.1

Net cash from / (used in) operating activities (item 1.9)

(3,242)

 

Adjustment for R&D incentive received

(2,086)

 

Adjusted net cash from / (used in) operating activities

(5,328)

8.2

Cash and cash equivalents at quarter end (item 4.6)

31,431

8.3

Unused finance facilities available at quarter end (item 7.5)

-

8.4

Total available funding (item 8.2 + item 8.3)

31,431

 

 

 

 

8.5

Estimated quarters of funding available (item 8.4 divided by item 8.1)

5.9

Note: if the entity has reported positive net operating cash flows in item 1.9, answer item 8.5 as “N/A”. Otherwise, a figure for the estimated quarters of funding available must be included in item 8.5.

8.6

If item 8.5 is less than 2 quarters, please provide answers to the following questions:

 

8.6.1

Does the entity expect that it will continue to have the current level of net operating cash flows for the time being and, if not, why not?

 

Answer:

 

 

 

8.6.2

Has the entity taken any steps, or does it propose to take any steps, to raise further cash to fund its operations and, if so, what are those steps and how likely does it believe that they will be successful?

 

Answer:

 

 

 

8.6.3

Does the entity expect to be able to continue its operations and to meet its business objectives and, if so, on what basis?

 

Answer:

 

 

 

Note: where item 8.5 is less than 2 quarters, all of questions 8.6.1, 8.6.2 and 8.6.3 above must be answered.

 

Compliance statement

1 This statement has been prepared in accordance with accounting standards and policies which comply with Listing Rule 19.11A.

2 This statement gives a true and fair view of the matters disclosed.

 

 

Date: 25 October 2022

 

Authorised by: The Board

(Name of body or officer authorising release – see note 4)

 

 

ASX Listing Rules Appendix 4C (17/07/20) Page 5

+ See chapter 19 of the ASX Listing Rules for defined terms.

Appendix 4C

Quarterly cash flow report for entities subject to Listing Rule 4.7B

 

Notes

1. This quarterly cash flow report and the accompanying activity report provide a basis for informing the market about the entity’s activities for the past quarter, how they have been financed and the effect this has had on its cash position. An entity that wishes to disclose additional information over and above the minimum required under the Listing Rules is encouraged to do so.

2. If this quarterly cash flow report has been prepared in accordance with Australian Accounting Standards, the definitions in, and provisions of, AASB 107: Statement of Cash Flows apply to this report. If this quarterly cash flow report has been prepared in accordance with other accounting standards agreed by ASX pursuant to Listing Rule 19.11A, the corresponding equivalent standard applies to this report.

3. Dividends received may be classified either as cash flows from operating activities or cash flows from investing activities, depending on the accounting policy of the entity.

4. If this report has been authorised for release to the market by your board of directors, you can insert here: “By the board”. If it has been authorised for release to the market by a committee of your board of directors, you can insert here: “By the [name of board committee – eg Audit and Risk Committee]”. If it has been authorised for release to the market by a disclosure committee, you can insert here: “By the Disclosure Committee”.

5. If this report has been authorised for release to the market by your board of directors and you wish to hold yourself out as complying with recommendation 4.2 of the ASX Corporate Governance Council’s Corporate Governance Principles and Recommendations, the board should have received a declaration from its CEO and CFO that, in their opinion, the financial records of the entity have been properly maintained, that this report complies with the appropriate accounting standards and gives a true and fair view of the cash flows of the entity, and that their opinion has been formed on the basis of a sound system of risk management and internal control which is operating effectively.

 

ASX Listing Rules Appendix 4C (17/07/20) Page 6

+ See chapter 19 of the ASX Listing Rules for defined terms.