• Dimerix raises a further AU $4.5 million via a significantly oversubscribed Placement.
• The Capital Raising was expanded to meet very strong demand from existing and new institutional, sophisticated and professional investors.
• Total capital raised via the Entitlement Offer and Placement of AU $7.55 million leaving Dimerix well funded to complete the Phase 2 clinical trial in the rare kidney disease, FSGS (orphan indication).
MELBOURNE, Australia, 21 February 2018 – Dimerix Limited or the “Company” (ASX: DXB), a clinical-stage biotechnology company developing new therapeutic treatments using its proprietary assay technology has raised an additional AU $4.5 million through the issue of 37,500,000 shares at 12 cents per share to wholesale and institutional clients of Westar Capital and Baker Young Stockbrokers who acted as Joint Lead managers to the Issue.
Dimerix is now funded to advance and deliver on its clinical milestones and partnering programs.
On 24 January 2018, Dimerix announced that it had received acceptances of AU $3,056,116 from the recently closed 1:2 Entitlement Offer at 12 cents per share with the shortfall of AU $2,468,790 to be placed in the near future.
Subsequent to the January announcement, Dimerix opened up the Entitlement Offer shortfall to new investors and received a substantial amount of interest. Given the strong demand for the stock, the Board determined to accept additional funding of approximately AU $2 million, (with allocations scaled back) to accept a total of AU $4,500,000 (37,500,000 shares at 12 cents per share) in new funding, with the oversubscription amount to be issued under the company’s placement capacity pursuant to LR 7.1 and 7.1A (see below). The total funds raised, when combined with the acceptances to the Entitlement Offer completed in January 2018, is AU $7,556,116 before costs.
CEO of Dimerix, Kathy Harrison stated, “We have been absolutely delighted with the strong support demonstrated by existing and new investors in management, and our strategy as we prepare for the next stage of our development programs. I’m pleased to warmly welcome new shareholders to the register and thank those existing shareholders who have invested in our growth.
“Dimerix is now fully funded to further the Company’s development plans and to take our lead compound, DMX-200 into a Phase 2 trial this quarter for the treatment of the rare kidney disease, FSGS. The funding will enable us to complete the steps required to develop commercial scale batches of DMX-200, and complete the remaining non-clinical studies to take DMX-200 to Phase 3 ready for FSGS.
“Importantly, we are now in a strong position to continue our partnering discussions and exploit the full commercial potential for DMX-200 in diabetic nephropathy, and other pipeline opportunities.”
The new shares are expected to be issued on Tuesday 27 February 2018.
About the Entitlement Offer and Placement
The results of the Entitlement Offer and Placement are set out as follows:
* 13,000,000 shares at 12 cents per share will be issued pursuant to the company’s placement capacity under listing rule 7.1A and meets the minimum price required under LR7.1A3 (per ASX). 3,926,753 shares at 12 cents per share will be issued pursuant to the company’s placement capacity under listing rule 7.1.
About Dimerix Bioscience Pty Ltd
Dimerix Limited’s (ASX: DXB) 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.
For more information see www.dimerix.com
About the DMX-200 program
DMX-200, which succssfully completed a Phase 2a clinical trial in humans, 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 anti-inflammatory 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).
Dimerix released the results of its Phase 2a clinical trial in humans for DMX-200 in July 2017. The trial met its primary endpoint of safety and tolerability in the participating patient group, which included patients with diabetic nephropathy (10), IgA nephropathy (6), and other proteinuric diseases (11). As a secondary endpoint, DMX-200 was shown to reduce levels of proteinuria in a number of patients. This was deemed a “clinically meaningful” result by leading clinicians. Sub set analysis released in November 2017 showed both a statistically significant and clinically meaningful reduction in proteinuria in the diabetic nephropathy cohort of patients.
Dimerix intends to take DMX-200 into clinical trials to test efficacy in calendar 2018 starting with its lead program in focal segmental glomerulosclerosis (FSGS), for which it has orphan drug designation in the US. Dimerix plans to take DMX-200 for diabetic nephropathy (DN) into a Phase 2b trial in H2 calendar 2018 or early calendar 2019.
About Chronic Kidney Disease
Chronic Kidney Disease (CKD) is a disorder in which patients show progressive loss of renal function usually accompanied by excess protein in the urine (proteinuria). Levels of proteinuria predict rate of decline of renal function (higher levels = more rapid decline). In part this is believed to reflect direct toxicity, or damage, to the kidneys by proteinuria itself. This establishes a cycle of worsening renal function leading in turn to increasing proteinuria and further kidney damage. Many CKD patients progress to a need for renal replacement therapy or dialysis and / or experience excessive morbidity and mortality from cardiovascular-related diseases.
The prevalence of CKD is rising and as such there is urgent need for treatments that can benefit CKD patients, including reducing proteinuria. In most cases of CKD residual proteinuria continues even with optimal use of existing therapies. Accordingly, therapies designed to further reduce, or abolish, proteinuria, are eagerly sought.
The rationale behind the DMX-200 program is to provide patients with a therapy that can reduce proteinuria in addition to that achieved with standard best therapy. The unmet need of CKD patients is reinforced by Dimerix’s Orphan Drug Designation.
(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.
Issued for and on behalf of Dimerix Ltd by Instinctif Partners.
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Sue CharlesManaging Partner