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VECTUS BIOSYSTEMS LIMITED Interim / Quarterly Report 2021

Apr 28, 2021

65993_rns_2021-04-28_797ab330-29fe-46d9-9bcd-583fab498928.pdf

Interim / Quarterly Report

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29 April 2021

Company Announcements Office Australian Securities Exchange

QUARTERLY ACTIVITIES REPORT AND APPENDIX 4C

In accordance with ASX Listing Rule 4.7B, Vectus Biosystems Limited (Vectus or the Company) presents its March 2021 Quarterly Activities Report and Quarterly Cash Flow Report – Appendix 4C.

Overview

  • Investigator Brochure, trial protocol, as well as various consent forms, submitted for ethics approval in relation to Phase I clinical trial for VB0004.

  • Contract signed with PCI Pharma Services covering clinical manufacturing and packaging of VB0004 capsules and matched placebo capsules for Phase I clinical trial.

  • Notices of allowance / intention to grant from Australia, Europe and the USA for patents covering both compositions and methods of use for VB0002, VB0003 and VB0005.

  • World demand for anti-fibrotic compounds is expected to accelerate in order to treat longer-term effects on certain COVID-19 patients, so-called “long COVID syndrome”.

Commentary on Activities for March 2021 Quarter

Vectus’ technical programmes and Good Manufacturing Practice (GMP) production progressed positively during the third quarter of the 2020-21 financial year (quarter). The Company has engaged PCI Pharma Services in Melbourne to undertake the clinical manufacturing and packaging of the VB0004 capsules and matched placebo capsules for the Phase I clinical trial. PCI Pharma Services (formerly Pharmaceutical Packaging Professionals) is an industry leader in clinical manufacturing for early phase clinical trials, and is able to provide formulation, packaging, analytical services and appropriate storage facilities for GMP products such as VB0004.

The final revised versions of the Investigator Brochure, trial protocol, as well as the various consent forms, have been submitted for consideration by the Human Research Ethics Committee. Currently, the indicative feedback from the trial site, Nucleus Network (Alfred Hospital, Melbourne), on timelines remains that the Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) components of the Phase I Clinical Trial are likely to be completed in mid to late Quarter 4 of the 2021 calendar year.

Patents

During the quarter there was an increase in the number of allowed / granted patents. Vectus has received notices of allowance / intention to grant from Australia, Europe and the USA for the patents covering both compositions and methods of use for VB0002, VB0003 and VB0005. The patents also cover the associated libraries for each of these compounds; in total, more than 700 unique compounds are included. These compounds can now be investigated for potential application in other fibrotic franchises such as retinal (eye) fibrosis, keloid (scars), osteoarthritis and post-surgical adhesions. The patent covering the Company’s D compounds, encompassing the treatment of pulmonary fibrosis, has been granted in Russia.

VECTUS BIOSYSTEMS LIMITED ABN 54 117 526 137

3-11 Primrose Avenue, Rosebery, NSW 2018 Telephone: +61 2 9662 4144 Facsimile: +61 2 9697 0933 Website: www.vectusbiosystems.com.au

Vectus Quarterly Report

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Finance and Corporate

The funds expended during the quarter were largely in connection with the preparatory work for the Phase I clinical trials for VB0004, to advance the library of Vectus’ other drugs and for general working capital. Payments for research, patents, staff costs and Directors’ fees for the quarter amounted to $441,000. Payments to related parties during the quarter were the Chief Executive Officer’s salary of $53,000, Non-Executive Directors’ fees of $33,000 and interest of $19,000 on the $957,000 loan from Non-Executive Director Maurie Stang. During the quarter, fees of $42,000 for corporate services, in line with budget, were paid to Regional Healthcare Group Pty Ltd and Aeris Environmental Ltd, both of which Maurie Stang is a Director. The Company’s Research and Development Cash-Back application is near completion, with an expected refund of more than $450,000 anticipated.

General

World demand for anti-fibrotic compounds is expected to accelerate in order to treat the longer-term effects on certain COVID-19 patients, the so-called “long COVID syndrome”. As many of these prolonged effects relate to fibrotic damage to organs such as the heart and lungs, Vectus may be uniquely placed to provide possible therapeutic solutions.

If the forthcoming Phase I clinical trial confirms the preclinical safety profile of VB0004 in humans, the Company will be in a position to accelerate other compounds, such as VB4-A32, through GMP synthesis and Investigational New Drug toxicology studies to human Phase I clinical trials.

Vectus Biosystems Limited

Karen Duggan

Chief Executive Officer and Executive Director

This announcement was authorised by the Board of Directors.

2

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Appendix 4C

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

Name of entity

Vectus Biosystems Limited

ABN
54 117 526 137
Quarter ended("currentquarter")
54 117 526 137 31 March 2021

Consolidated statement of cash flows

1 Cash flows from operating activities
1.1 Receipts from customers
1.2 Payments for
(a)
patent and research expenses
(b)
staff costs and directors' fees
(c)
occupancy cost
(d)
corporate overheads
(e)
legal and professional fees
(f)
other operating costs, including working capital
1.3 Dividends received
1.4 Interest and other items of a similar nature received
1.5 Interest and other costs of finance paid
1.6 Income tax refund received (including R&D tax offset)
1.7 Government grants and tax incentives
1.8 Others (provide details if material)
1.9 Net cash from /(used in) operating activities
Current
quarter
$A'000
Year to date
(9 months)
$A'000
- -
(236)
(205)
-
(54)
(72)
(50)
-
-
(20)
-
-
-
(873)
(581)
-
(190)
(204)
(153)
-
-
(64)
-
51
-
(637) (2,014)
Consolidated statement of cash flows
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
(c)
property, plant and equipment
(d)
investments
(e) intellectual property
(f)
other non-current assets
2.3 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
Current
quarter
$A'000
Year to date
(9 months)
$A'000
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
(9)
-
-
-
-
-
-
-
-
-
-
-
- (9)
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 Repayment of borrowings
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
-
-
-
-
-
-
-
-
-
7,000
31
-
(113)
-
-
-
-
-
- 6,918
Consolidated statement of cash flows
4 Net increase / (decrease) in cash and cash
equivalents for the period
4.1 Cash and cash equivalents at beginning of period
4.2 Net cash from / (used in) operating activities
(item 1.9 above)
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)
4.5 Effect of movement in exchange rates on cash held
4.6 Cash and cash equivalents at end ofperiod
Current
quarter
$A’000
8,217
(637)
-
-
-
Year to date
(9 months)
$A'000
2,685
(2,014)
(9)
6,918
-
7,580 7,580
5 Reconciliation of cash and cash equivalents
5.1 Cash on hand and at bank
5.2 Term Deposits
5.3 Bank overdrafts
5.4 Other (provide details)
5.5 Cash and cash equivalents at end of quarter (item 4.6)
6
6.1
6.2
Aggregate amount of payments to related parties and their
associates included in item 1
Aggregate amount of payments to related parties and their
associates included in item 2
at the end of the quarter (as shown in the consolidated
statement of cash flows) to the related items in the
accounts
Payments to related parties of the entity and their
associates
Current
quarter
$A'000
Previous
quarter
$A'000
7,525
55
-
-
8,162
55
-
-
7,580 8,217
$A'000
147
-
Current
quarter
$A'000
Current
quarter
147
-

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

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
Total
facility
$A'000
Amount
drawn
$A'000
957 957
- -
- -
957 957
-
  • 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.

The terms of the original loan facility made available of $2,500,000 by Director M Stang (current advance balance of $957,000 after the last repayment of $384,000 in May 2020) include an interest rate of 8% per annum, and security over all of the assets of the Company to secure past and future advances pursuant to the Director loan. The loan terms included a contractual obligation on the Company to utilise its future R&D tax offset payments from the ATO to repay the loan. The Company expects to repay a proportion of the balance of the loan in the June 2021 quarter when the June 2020 financial year R&D tax offset refund is received from the ATO. The security will be discharged when the loan is repaid.

8 Estimated cash available for future operating activities
8.1 Net cash from / (used in) operating activities (item 1.9)
8.2 Cash and cash equivalents at quarter end (item 4.6)
8.3 Unused finance facilities available at quarter end (item 7.5)
8.4 Total available funding (item 8.2 + item 8.3)
8.5 Estimated quarters of funding available
(item 8.4 divided by item 8.1)
$A'000
(637)
7,580
-
7,580
11.90
  • 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?

Not applicable

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?

Not applicable

  • 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?

Not applicable

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: 29 April 2021

Authorised for release to the market by the Vectus Board of Directors.

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.