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DIMERIX LIMITED Interim / Quarterly Report 2016

Jan 22, 2017

64804_rns_2017-01-22_eba9b606-3001-4ba6-ba65-b77268b4133f.pdf

Interim / Quarterly Report

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23 January 2017

QUARTERLY CASH FLOW REPORT

Dimerix is pleased to present the cash flow report for the quarter ended 31 December 2016. The Company has also lodged its Research & Development Tax Incentive claim for approximately $420,000 which the Company expects to receive in February 2017.

For more information please contact:

At the company Media (Australia) Media (International)
Kathy Harrison
Chief Executive Officer
Dimerix Limited
Tel: +61 419 359 149
E: [email protected]

Andrew Geddes
Tel: +61 408 677 734
E: [email protected]
Sue Charles/Daniel Gooch
Tel: +44 (0)20 7866 7905
E: [email protected]

Dimerix Bioscience Pty Ltd

Dimerix Limited’s wholly owned subsidiary Dimerix Bioscience Pty Ltd is a clinical-stage pharmaceutical company committed to discovering and developing new therapeutic models identified using its proprietary assay, termed Receptor-Heteromer Investigation Technology (Receptor-HIT). This assay enables the identification of pairs of receptors that function in a joint manner (interact) when ligands, small molecule drugs, peptides or antibodies, bind to them. The Receptor-HIT technology was used to identify DMX-200 in an internal drug development program, initially for the treatment of a subset of patients with chronic kidney disease. In addition to its own therapeutic programs, the company also earns revenue by providing this technology to global pharmaceutical companies. For more information see www.dimerix.com

DMX 200

DMX-200 is being developed as an adjunct therapy, adding propagermanuim to a stable dose of irbesartan. Irbesartan is an off-patent angiotensin II type I receptor blocker indicated for the treatment of hypertension and nephropathy in Type II diabetic patients. Propagermanium (PPG) is a chemokine receptor (CCR2) blocker, which has been used for the treatment of Hepatitis B in Japan and is available in the USA for its antiinflammatory properties. DMX-200 has been shown to improve the outcome of chronic kidney disease by reducing proteinuria by more than 50 per cent in animal models[(1)] .

The DMX-200 Phase II Trial

The trial is a single arm, open label study in adult patients with chronic kidney disease (with proteinuria). The primary end points are the incidence and severity of adverse events and the clinically significant changes in the safety profile of participants. The secondary end points are obtained from statistical analysis of biomarker data at each time point including change from baseline, and the proportion of responders defined as those participants achieving normalisation of proteinuria (proteinuria within normal limits) or those participants achieving a 50 per cent reduction in proteinuria.

Dimerix Limited (ABN 18 001 285 230) Registered office: Suite 5, 95 Hay St, Subiaco WA 6008, Australia PO Box 226, Subiaco WA 6904, Australia

Web: www.dimerix.com

The trial has two parts. Part A is a dose escalation trial recruiting up to 30 patients and completed enrolment at the end of November 2016. All patients recruited to the trial will be on stable irbesartan therapy, and will be treated with propagermanium dosed orally three times per day. Each patient will commence on 30mg PPG/day and the dose increased each 28 days to a maximum of 240mg/day, or until proteinuria is absent or reduced to a level the clinician considers acceptable. The Company expects to complete Part A in mid-2017.

Part B is an expansion study, in which up to 30 patients will be given the optimal dose identified from Part A.

Chronic Kidney Disease

Chronic kidney disease can result from diabetes, high blood pressure and diseases that cause inflammation specifically in the kidneys. Proteinuria is the most common manifestation of the disease. As the disease progresses it can lead to end-stage renal disease (ESRD) where the kidneys fail. The only treatment for ESRD is a kidney transplant or regular blood-cleansing treatments called dialysis. More than 26 million people suffer from the disease in the United States.

[(1) ] Functional interaction between angiotensin II receptor type 1 and chemokine (C-C motif) receptor 2 with implications for chronic kidney disease. Ayoub MA, Zhang Y, Kelly RS, See HB, Johnstone EK, McCall EA, Williams JH, Kelly DJ, Pfleger KD. PLoS One. 2015 Mar 25;10(3):e0119803. doi: 10.1371/journal.pone.0119803.

+Rule 4.7B

Appendix 4C Quarterly report for entities subject to Listing Rule 4.7B

Introduced 31/03/00 Amended 30/09/01, 24/10/05, 17/12/10, 01/09/16

Name of entity

Name of entity Name of entity Name of entity
DIMERIX LIMITED
ABN
18 001 285 230
Quarter ended (“current quarter”)
31-12-16
Consolidated statement of cash flows **Current quarter $A’000 ** Year to date (6
months) $A'000
1.0
1.1
1.2
1.3
1.4
1.5
1.6
1.7
1.8
1.9
Income taxes paid
Government grants and tax incentives
Other (provide details if material)
Net cash from / (used in) operating activities
(d) leased assets
(e) staff costs
(f) administration and corporate costs
Dividends received (see note 3)
Interest received
Interest and other costs of finance paid
Cash flows from operating activities
Receipts from customers
Payments for
(a) research and development
(b) product manufacturing and operating costs
(c) advertising and marketing
(265)
(52)
(226)
3
(567)
(184)
(487)

8
(539) (1,231)
Cash flows from investing activities
Payments to acquire:
(a) property, plant and equipment
(b) businesses (see item 10)
(c) investments
(d) intellectual property
(e) other non-current assets
Proceeds from disposal of:
(a) property, plant and equipment
(b) businesses (see item 10)
(c) investments
(d) intellectual property
(e) other non-current assets
Cash flows from loans to other entities
Dividends received (see note 3)
Other (provide details if material)
Net cash from / (used in) investing activities
2.3
2.4
2.5
2.6
2.2
2.0
2.1
- -
Cash flows from financing activities
Proceeds from issues of shares
Proceeds from issue of convertible notes
Proceeds from exercise of share options
Transaction costs related to issues of shares,
convertible notes or options
Proceeds from borrowings
Repayment of borrowings
Transaction costs related to loans and
borrowings
Dividends paid
Other (provide details if material)
Net cash from / (used in) financing activities
3.7
3.8
3.9
3.1
3.1
3.2
3.3
3.4
3.5
3.6
3.0
0
221
0
221
Net increase / (decrease) in cash and
cash equivalents for the period
Cash and cash equivalents at beginning of
quarter/year to date
Net cash from / (used in) operating activities
(item 1.9 above)
Net cash from / (used in) investing activities
(item 2.6 above)
Net cash from / (used in) financing activities
(item 3.10 above)
Effect of movement in exchange rates on cash
held
Cash and cash equivalents at end of quarter
4.1
4.2
4.3
4.4
4.5
4.6
4.0
1,548
(539)
0

2,019
(1,231)

221
1,009
1,009
Reconciliation of cash and cash
equivalents
at the end of the quarter (as shown in the
consolidated statement of cash flows) to the
relateditemsinthe accounts
5.0
Current quarter
$A’000
Previous quarter
$A’000
Bank balances
Call deposits
Bank overdrafts
Other (provide details)
Cash and cash equivalents at end of quarter
(should equal item 4.6 above)
5.1
5.2
5.3
5.4
5.5
55
954

40

1,508
1,009
1,548
6.3
Include below any explanation necessary to understand the transactions
included in items 6.1 and 6.2
6.0
Payments to directors of the entity and their associates
6.1
Aggregate amount of payments to these parties included in item 1.2
6.2
Aggregate amount of cash flow from loans to these parties included in
item 2.3
Current quarter
$A'000
61

Current quarter $A'000

Payments to related entities of the entity and their associates

7.0

7.1 Aggregate amount of payments to these parties included in item 1.2 Aggregate amount of cash flow from loans to these parties included in 7.2 item 2.3 Include below any explanation necessary to understand the transactions included in items 7.1 and 7.3 7.2

Financing facilities available
Add notes as necessary for an understanding of
the position
Loan facilities
Credit standby arrangements
Other (please specify)
Total facility amount
at quarter end
Amount drawn at
quarter end

$A’000

$A’000

8.0 Add notes as necessary for an understanding of the position

  • 8.1 Loan facilities

  • 8.2 Credit standby arrangements

  • 8.3 Other (please specify)

Include below a description of each facility above, including the lender, interest rate and whether it 8.4 is secured or unsecured. If any additional facilities have been entered into or are proposed to be entered into after quarter end, include details of those facilities as well.

9.0
Estimated cash outflows for next quarter
$A’000
9.6
Administration and corporate costs
9.7
Other (provide details if material)
9.8
Total estimated cash outflows
9.3
Advertising and marketing
9.4
Leased assets
9.5
Staff costs
9.1
Research and development
9.2
Product manufacturing and operating costs
264
94
85
443
Acquisitions and disposals of business
entities
(items 2.1(b) and 2.2(b) above)
Name of entity
Place of incorporation or registration
Consideration for acquisition or disposal
Total net assets
Nature of business
10.4
10.5
10.0
10.1
10.2
10.3
Acquisitions Disposals

Compliance statement

  • This statement has been prepared in accordance with accounting standards and policies which comply with

  • 1 Listing Rule 19.11A.

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

Sign here: Company secretary Print name: Ian Hobson

Date: 23 January 2017

Notes

  • The quarterly report provides a basis for informing the market how the entity’s activities have been financed for

  • 1 the past quarter and the effect on its cash position. An entity that wishes to disclose additional information is encouraged to do so, in a note or notes included in or attached to this report.

  • If this quarterly 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 report has been

  • 2 prepared in accordance with other accounting standards agreed by ASX pursuant to Listing Rule 19.11A, the corresponding equivalent standard applies to this report.

  • Dividends received may be classified either as cash flows from operating activities or cash flows from investing

  • 3 activities, depending on the accounting policy of the entity.