Activities Report and Appendix 4C
Released
Released
Announcement PDF
ASX ANNOUNCEMENT
ACTIVITY REPORT AND CASH FLOW REPORT
FOR THE QUARTER ENDED 31 DECEMBER 2023
Highlights:
Invion completes lodgement of the clinical trial application with the Human Research
Ethics Committee (HREC);
Invion is using an adaptive trial design for greater flexibility to incorporate dose
optimisation and efficacy signal endpoints, on top of safety data, in its Phase I/II nonmelanoma skin cancer (NMSC) trial;
First patient recruitment is expected in the coming months (subject to HREC approval);
Separately, in the oral antimicrobial space, Invion is focusing on periodontal diseases,
which represent a significant unmet need.
MELBOURNE (AUSTRALIA) 30 January 2024: Invion Limited (ASX: IVX) (“Invion” or the
“Company”) wishes to provide the following update and Appendix 4C for the quarter ended
31 December 2023 (2QFY24).
Summary of cash position and expenditure during the quarter
The Company held cash reserves at the end of the quarter of $1.9 million, compared with $3.4
million for 1QFY24.The decline is largely driven by net operating cash outflow of $1.5 million
during the quarter.
Invion remains funded through its research and development (R&D) services agreement with
RMW Cho Group (RMW), the licensor of the Photosoft™ technology, and fluctuations in its
operating cash flows are influenced by the timing of payments and receipts.
Under the R&D agreement, RMW reimburses Invion for all cancer-related research in Australia
and New Zealand. For other research in Invion’s territories, RMW will reimburse 75% of nonclinical and 25% of clinical activities.
Invion’s key cash outflows under Operating Activities in the quarter were R&D of $1.1 million
and administration and corporate costs of $404k.
As detailed in Item 6.1 of the accompanying Appendix 4C, the Company discloses that the
aggregate payments to related parties and their associates during the quarter totalled $139k.
The payment relates to CEO compensation and Directors fees paid in the period.
Progress on clinical trials program
Invion achieved several key milestones in the December 2023 quarter as it executes on its
clinical trial plan. This included the manufacturing of INV043, Invion’s lead drug candidate, at
IDT Australia Limited (ASX: IDT) under Good Manufacturing Practice (GMP) standards. This
ensures Invion is well placed to undertake current and future clinical trials to treat cancers.
Further, Invion submitted its Human Research Ethics Committee (HREC) application for the
Phase I/II non-melanoma skin cancer (NMSC) clinical trial on 21 December 2023 and is looking
to partner with Veracity Clinical Research (Veracity) in Queensland to conduct the trial.
Invion Limited ABN 76 094 730 417
100 Albert Road, South Melbourne, VIC 3205
P: +61 3 9692 7222 W: www.inviongroup.com
ASX ANNOUNCEMENT
The ethics submission is a major milestone in the regulatory process within Australia. Once
approved, the Therapeutic Goods Administration (TGA) is notified, generating a Clinical Trial
Notification (CTN), which is required to commence patient recruitment planned from early
2024 (subject to HREC approval).
“This marks the beginning of an important chapter in our journey in our first clinical trial that will
target non-melanoma skin cancers. The skin cancer market is forecast to hit US$14.6 billion by
20321 and Australia has the highest incidence of the disease globally2. INV043 has the potential
to offer a superior treatment option as it may prove to be as effective as surgery but without
causing scarring or pain,” said Invion’s Executive Chair and Chief Executive Officer, Thian
Chew.
“With INV043 protected by a patent recently granted in Australia, we are in a strong position
to advance our clinical trial program.”
Invion is proposing to use an adaptive trial design with a topical ointment, subject to HREC
approval, which will give the Company increased flexibility in running the trial on cutaneous
Squamous Cell Carcinoma (cSCC) and superficial Basal Cell Carcinoma (sBCC) skin cancers,
which account for over 98% of all skin cancers3.
As a result of the adaptive design, this clinical trial may go beyond a typical Phase I trial scope
as the trial results will not only include safety data but may also include dose optimisation as
well as efficacy signals. Invion also has the ability to adjust the scope from a smaller to a larger
trial size depending on progressive findings and their relevance to prevailing objectives.
Further, Invion has taken the approach of using INV043 manufactured under Good
Manufacturing Practice (GMP) in the formulation of the topical ointment, which is a higher
quality level than is required for Australian Phase I trials.
“This is a significant step in advancing INV043, which we believe has the potential to provide
new options for treating multiple cancers,” said Mr Chew.
“We have demonstrated efficacy of INV043 to treat different cancer types in pre-clinical
studies, and the transition into the treatment of people suffering from NMSCs is very exciting for
Invion and its shareholders.”
Update on Oral Microbial Opportunities
In a separate development during the quarter, Invion decided to focus on periodontal
diseases as it explores opportunities in the oral antimicrobial space. The Company believes
periodontal diseases are a more commercially attractive market for the Photosoft™
technology as opposed to other antimicrobial applications, particularly in the United States,
which is an exclusive territory for Invion (under infectious diseases).
Around 19% of adults, or over one billion adults, world-wide suffer from severe periodontal
diseases4. These incidences are often related to tooth implant procedures where many
patients pay out-of-pocket for treatments.
Further, periodontists are looking for alternative treatments to surgery and antibiotics to deal
with infections, which are common following such procedures.
https://www.precedenceresearch.com/melanoma-therapeutics-market
https://www.statista.com/statistics/1032114/countries-with-the-greatest-rates-of-skin-cancer/
3
https://www.cancer.net/cancer-types/skin-cancer-non-melanoma/introduction
4
https://www.who.int/news-room/fact-sheets/detail/oral-health
1
2
Invion Limited ABN 76 094 730 417
100 Albert Road, South Melbourne, VIC 3205
P: +61 3 9692 7222 W: www.inviongroup.com
ASX ANNOUNCEMENT
Twenty percent of implant patients suffer from peri-implantitis, which if left untreated leads
to implant loss5
Illustrative concept
Investing & Financing activities
Invion did not record any cash movements from its Investing and Financing Activities in the
quarter.
The Company believes its cash position of over $1.9 million (with no debt) and its funding
arrangement with RMW will enable it to pursue its current development agenda. Further,
Invion is currently assessing potential collaborations with partners, as well as other financing
discussions to facilitate funding the upcoming clinical trials and operations.
This announcement was approved for release by the Board of Directors.
____________________________________________
Investor and Media enquiries:
Thian Chew (Chairman & CEO)
T: +61 3 9692 7222
E: investor@inviongroup.com
Brendon Lau (Investor & Media Relations)
M: +61 409 341 613
E: brendon.lau@inviongroup.com
About Invion
Invion is a life-science company that is leading the global research and development of the
PhotosoftTM technology for the treatment of a range of cancers, atherosclerosis and infectious
diseases. Invion holds the exclusive Australia and New Zealand license rights and exclusive
distribution rights to Asia Pacific excluding China (other than Hong Kong, which is included in
the Territory), Macau, Taiwan, Japan and South Korea to the PhotosoftTM technology for all
5
https://pubmed.ncbi.nlm.nih.gov/28478213/
Invion Limited ABN 76 094 730 417
100 Albert Road, South Melbourne, VIC 3205
P: +61 3 9692 7222 W: www.inviongroup.com
ASX ANNOUNCEMENT
cancer indications. It also holds the exclusive rights to the technology in Asia Pacific (excluding
Greater China) for atherosclerosis and infectious diseases. Research and clinical cancer trials
are funded by the technology licensor, RMW Cho Group Limited, via an R&D services
agreement with the Company. Invion is listed on the ASX (ASX: IVX). For more information, visit
www.inviongroup.com.
About Photodynamic Therapy (PDT)
Invion is developing PhotosoftTM technology as a novel next generation Photodynamic
Therapy (PDT). PDT uses non-toxic photosensitisers and light to selectively kill cancer cells and
promote an anti-cancer immune response. Less invasive than surgery and with minimal side
effects, PDT offers an alternative treatment option aimed at achieving complete tumour
regression and long-lasting remission.
Invion Limited ABN 76 094 730 417
100 Albert Road, South Melbourne, VIC 3205
P: +61 3 9692 7222 W: www.inviongroup.com
Rule 4.7B
Appendix 4C
Quarterly cash flow report for entities
subject to Listing Rule 4.7B
Name of entity
INVION LTD
ABN
Quarter ended (“current quarter”)
76 094 730 417
31 December 2023
Consolidated statement of cash flows
Current quarter
$A’000
1.
Cash flows from operating activities
1.1
Receipts from customers
1.2
Payments for
Year to date
(6 months)
$A’000
-
1,600
(1,068)
(2,007)
(b) product manufacturing and operating
costs
-
-
(c) advertising and marketing
-
-
(d) leased assets
-
-
(e) staff costs
-
-
(404)
(888)
-
-
22
51
(a) research and development
(f)
administration and corporate costs
1.3
Dividends received (see note 3)
1.4
Interest received
1.5
Interest and other costs of finance paid
-
-
1.6
Income taxes paid
-
-
1.7
Government grants and tax incentives
-
-
1.8
Other (provide details if material)
-
-
1.9
Net cash from / (used in) operating
activities
(1,450)
(1,244)
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
-
(900)
(f)
-
-
other non-current assets
ASX Listing Rules Appendix 4C (17/07/20)
+ See chapter 19 of the ASX Listing Rules for defined terms.
Page 1
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
Consolidated statement of cash flows
2.2
Current quarter
$A’000
Year to date
(6 months)
$A’000
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
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
-
(900)
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
-
-
4.
Net increase / (decrease) in cash and
cash equivalents for the period
4.1
Cash and cash equivalents at beginning of
period
3,391
4,085
(1450)
(1,244)
-
(900)
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)
ASX Listing Rules Appendix 4C (17/07/20)
+ See chapter 19 of the ASX Listing Rules for defined terms.
Page 2
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
Consolidated statement of cash flows
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
5.
Current quarter
$A’000
Year to date
(6 months)
$A’000
-
-
-
-
Cash and cash equivalents at end of
period
1,941
1,941
Reconciliation of cash and cash
equivalents
Current quarter
$A’000
Previous quarter
$A’000
at the end of the quarter (as shown in the
consolidated statement of cash flows) to the
related items in the accounts
5.1
Bank balances
941
1,891
5.2
Call deposits
1,000
1,500
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)
1,941
3,391
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
139
6.2
Aggregate amount of payments to related parties and their
associates included in item 2
-
Current quarter
$A'000
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.
ASX Listing Rules Appendix 4C (17/07/20)
+ See chapter 19 of the ASX Listing Rules for defined terms.
Page 3
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
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.
8.
Estimated cash available for future operating activities
8.1
Net cash from / (used in) operating activities (item 1.9)
(1,450)
8.2
Cash and cash equivalents at quarter end (item 4.6)
1,941
8.3
Unused finance facilities available at quarter end (item 7.5)
8.4
Total available funding (item 8.2 + item 8.3)
1,941
8.5
Estimated quarters of funding available (item 8.4 divided by
item 8.1)
1.34
-
$A’000
-
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?
Invion recorded a higher than usual level of expenses, which are related to its
upcoming clinical trials. This includes the successful manufacturing of INV043 drug
substance under Good Manufacturing Practice (GMP) compliant manufacturing
process, which was announced on 21 November 2023. It also completed its
preclinical work required for the upcoming non-melanoma skin cancer clinical trial,
prompting larger than usual payments to vendors for the balance of various
contracted work.
Invion is currently awaiting Human Research Ethics Committee approvals to move
forward with its upcoming clinical trial programs, and until recruitment of patients
occurs for upcoming clinical trials, the entity expects a significant reduction in the
level of operating activity with a commensurate reduction in net operating cashflows.
ASX Listing Rules Appendix 4C (17/07/20)
+ See chapter 19 of the ASX Listing Rules for defined terms.
Page 4
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
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?
Invion has an R&D services agreement with the technology licensor, RMW Cho
Group (RMW), and all cancer-related research expenses in Australia and New
Zealand are reimbursed by RMW. Fluctuations in Operating Cash Flows are impacted
by the timing of receipts and payments.
Further, Invion continues to assess potential collaborations to cover any possible
future funding shortfall that may not be covered by the R&D services agreement. The
Company believes it is well positioned to raise additional cash under at least one of
these scenarios.
Further, there is significant flexibility to delay or scale down activity and expenditure
to ensure alignment to its prevailing cash positions, if and as required.
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?
Yes, the entity expects to be able to continue to meet its operations and meet its
business objectives as a result of the actions contemplated in items 8.8.1 and 8.8.2
above.
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:
30 January 2024
Authorised by: By the Board...................................................................................
(Name of body or officer authorising release – see note 4)
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)
+ See chapter 19 of the ASX Listing Rules for defined terms.
Page 5
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