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29 July 2022
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 June 2022 Quarterly Activities Report and Quarterly Cash Flow Report - Appendix 4C.
Overview
VB0004 Phase Ia human clinical trials are targeted for completion in the fourth quarter of calendar year 2022. The Single Ascending Dose (SAD) Cohorts 1 through 5, as well as Multiple Ascending Dose (MAD) Cohort 6, have been completed and MAD Cohort 7 is in progress.
Shanghai Jadesen Management Co., Ltd (Shanghai Jadesen) has been appointed to provide professional advisory services in the People's Republic of China.
Commentary on Activities for June 2022 Quarter
During the quarter, Cohort 5 of the SAD study, in which participants received a single dose of 300mg of VB0004, was completed and the data was reviewed by the Trial Safety Review Committee. No significant adverse events were observed, which indicates a very large therapeutic safety margin for VB0004.
The first MAD cohort (Cohort 6), in which participants received a dose of 10mg of VB0004 daily for 14 days, was also completed and reviewed by the Trial Safety Review Committee, which gave permission for escalation to the next dose step, of 30mg of VB0004 daily for 14 days, to occur (Cohort 7). Enrolment for Cohort 7 has been completed.
The pharmacokinetic (PK) analysis from all SAD Cohorts confirms that the time taken for VB0004 to reach its maximal plasma concentration (Tmax) occurred six hours after dosing. In addition, this analysis indicated that VB0004 has a plasma half-life (the time taken for the plasma concentration to decrease by 50% from Tmax) in the range of 10 to 15 hours. These data provide more evidence that VB0004 will be amenable to once daily dosing, a desirable feature in medications for chronic conditions such as hypertension, heart failure, kidney failure and pulmonary fibrosis.
The Annual Safety Report was submitted and approved by the Human Research Ethics Committee of the Alfred Hospital.
The trial entitled "A phase I/Ib, first-time-in-human, single centre, double-blind, randomized, placebo- controlled, dose escalating study of the safety, tolerability and pharmacokinetics of single and repeat doses of VB0004 administered orally to healthy volunteers; and to patients with mild to moderate hypertension with low cardiovascular risk", is registered on the US Government Clinical Trials Protocol Registration and Results Systems (ClinicalTrials.gov) and has been provided with the identifier NCT04925050. Protocol details may be found using this number on the ClinicalTrials.gov public website.
During the quarter the Company announced the appointment of Shanghai Jadesen to provide professional advisory services, as detailed in the ASX announcement released to the market on 27 June 2022.
VECTUS BIOSYSTEMS LIMITED ABN 54 117 526 137
3-11 Primrose Avenue, Rosebery, NSW 2018 Telephone: +61 2 9381 1000 Facsimile: +61 2 9662 1720
Website: www.vectusbiosystems.com.au
Vectus Quarterly Report
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Patents
Vectus has received notice of grant of the patent for South Korea covering the D group of compounds. The patent relating to the probe method of PCR quantitation by Accugen has also been granted for South Korea.
Accugen
During the quarter the Company appointed a Product Development Manager to lead the development programme in the food safety and diagnostic testing using the Accugen technology. The technology, consisting of AccuCal™ and RealCount™ software, is owned by Vectus' wholly-owned subsidiary, Accugen Pty Limited.
Finance and Corporate
The funds expended by the Company during the recent quarter were largely in connection with the Phase I clinical trials for VB0004. Payments for Phase I, research, patents, staff costs and Directors' fees for the quarter amounted to $1,075,000. Cash on hand at 30 June 2022 was $1,281,000, and the research and development (R&D) refund of $936,000 for the year ended 30 June 2021 was received from the Australian Taxation Office (ATO) in July 2022. Payments to related parties during the quarter were the Chief Executive Officer's salary of $66,000 and the Non-Executive Directors' fees of $68,000. Interest of $9,000 was paid on the $442,000 loan from Non-Executive Director Maurie Stang. During the quarter, fees of $37,000 (for corporate services, including cost re-imbursement for information technology, human resources and accounting services, in line with budget) were paid to Regional Healthcare Group Pty Ltd, of which Non- Executive Director Maurie Stang is a director.
As mentioned above, an R&D refund of $936,000 for the year ended 30 June 2021 was received from the ATO in July 2022, and Vectus is accruing further receivables on current R&D expenditure. In addition, the Company had cash on hand at 30 June 2022 of $1,281,000 and a number of discussions are currently underway that could result in additional funding for Vectus.
Vectus Biosystems Limited
Karen Duggan
Chief Executive Officer and Executive Director
This announcement was authorised by the Board of Directors.
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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 | Quarter ended ("current quarter") | |
54 117 526 137 | 30 June 2022 | |
Consolidated statement of cash flows
1 | Cash flows from operating activities | Current | Year to date | |
quarter | (12 months) | |||
$A'000 | $A'000 | |||
1.1 | Receipts from customers | - | - | |
1.2 | Payments for | |||
(a) patent and research expenses | (693) | (2,415) | ||
(b) staff costs and directors' fees | (382) | (1,104) | ||
(c) | occupancy cost | (49) | (192) | |
(d) | corporate overheads | (185) | (372) | |
(e) legal and professional fees | (57) | (320) | ||
(f) other operating costs, including working capital | 26 | (46) | ||
1.3 | Dividends received | - | - | |
1.4 | Interest and other items of a similar nature received | - | - | |
1.5 | Interest and other costs of finance paid | (68) | (98) | |
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) | - | 50 | |
1.9 | Net cash from / (used in) operating activities | (1,408) | (4,497) |
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Consolidated statement of cash flows | Current | Year to date | ||
quarter | (12 months) | |||
$A'000 | $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 | - | - | |
(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 | - | - | |
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 | - | - |
Consolidated statement of cash flows
4 | Net increase / (decrease) in cash and cash | |
only | 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 |
use | 4.6 | Cash and cash equivalents at end of period |
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 | ||
personal | accounts | |
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 | Payments to related parties of the entity and their | |
associates | ||
6.1 | Aggregate amount of payments to related parties and their | |
associates included in item 1 | ||
6.2 | Aggregate amount of payments to related parties and their | |
For | associates included in item 2 | |
Current | Year to date |
quarter | (12 months) |
$A'000 | $A'000 |
2,689 | 5,778 |
(1,408) | (4,497) |
- | - |
- | - |
- | - |
1,281 | 1,281 |
Current | Previous |
quarter | quarter |
$A'000 | $A'000 |
1,226 | 2,634 |
55 | 55 |
- | - |
- | - |
1,281 | 2,689 |
Current | |
quarter | |
$A'000 |
180
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Vectus Biosystems Ltd. published this content on 28 July 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 28 July 2022 23:43:08 UTC.