Биотех Dimerix получила 34 млн австралийских долларов на финансирование клинических испытаний препаратов от болезней почек

DIMERIX SECURES A$34 MILLION NON-DILUTIVE FACILITY TO FUND KEY CLINICAL MILESTONES - Dimerix successfully enters into non-dilutive facility agreements to access A$34 million[1] with a syndicate of Australian and U.S. independent lenders, including the previously announced initial facility of A$10 million[2] - Facility terms for all Lenders substantially consistent with the previously announced loan facility;[2] with minor amendments made to the SKIPTAN agreement to standardise key terms across all Lenders (other than in respect of security, refer to Appendix 1) - Dimerix has elected to drawdown only 50% of the amount committed initially, which is considered sufficient to complete all currently planned activities, including delivery of the ACTION3 Phase 3 trial of DMX-200 and continued advancement of the Phase 2 trial of DMX-652 in Acute Kidney Injury[3] - The facility provides the option to secure up to A$50m in total commitments on or before 31 March 2027, should Dimerix elect to do so; noting the Company currently has no plans access this additional funding - Facility provides Dimerix with considerable financial flexibility without diluting shareholders MELBOURNE, Australia, Sept. 4, 2026 /PRNewswire/ -- Dimerix Limited (ASX: DXB, "Dimerix") a clinical-stage biopharmaceutical company developing kidney disease treatments, is pleased to announce that it has successfully secured non-dilutive loan facility agreements ("Loan Agreements") with a group of Australian and U.S. based lenders to access up to A$34 million[1] (see key terms in Appendix 1), including the existing A$10 million facility agreement with SKIPTAN.[2] "We are delighted with the support received from lenders across both Australia and the United States, reflecting growing confidence in Dimerix, our clinical programs and our mission to improve outcomes for patients suffering from serious kidney diseases. The successful entry into this facility provides Dimerix with the financial flexibility needed to execute our planned development activities without dilution for shareholders. Importantly, we have taken a disciplined approach and elected to access only the funding considered required to complete our currently planned activities. We believe this is in the best interests of shareholders, including completion of both the ACTION3 Phase 3 trial of DMX-200 and the Phase 2 trial of DMX-652 in Acute Kidney Injury. Kidney disease is now recognised as one of the fastest-growing causes of death globally, and yet treatment options remain limited for many patients. As a company dedicated exclusively to kidney disease, Dimerix remains focused on developing new treatment options that have the potential to improve and extend the lives of patients in urgent need." Dr Nina Webster, CEO & Managing Director, Dimerix Non-dilutive funding flexibility The facility has been established to support Dimerix's ongoing clinical development programs and provides the Company with significant financial flexibility while advancing its late-stage pipeline. The terms of the facility for the new lenders are substantially similar to those previously announced for the SKIPTAN facility (ASX: 17 July 2026), with SKIPTAN terms amended to ensure alignment (see Appendix 1 for details). The facility provides the flexibility for Dimerix to elect to take further commitments for up to a total of A$50m on or before 31 March 2027. Importantly, Dimerix has elected to initially drawdown only the amount of funding considered required to complete its currently planned activities, being 50% of the currently committed funds.[3] This disciplined approach to capital management minimises financing costs and shareholder dilution, while maintaining the flexibility to access additional capital under the facility if required in the future. Funded for ACTION3 trial and DMX-652 development activities Based on the Company's present operating plans and anticipated expenditure, Dimerix confirms that it is funded through to completion of the ACTION3 Phase 3 trial in DMX-200, as well as the planned Phase 2 clinical trial in DMX-652, through:[3] - Existing cash reserves; and - A$34 million[1] via the binding Loan Agreements, with receipt of the initial 50% draw-down anticipated in September 2026 and the remainder to take place at the Company's discretion on or before 31 March 2027. The facility is anticipated to be repaid through existing future licensee milestone payment(s), potential new license fees and/or capital market access. Dimerix has secured five commercial partners across major markets, generating A$81 million in upfront payments received to date and creating the opportunity for a further A$237 million in development milestone payments ahead of commercial launch.[4] Advancing a Leading Kidney Disease Pipeline Kidney disease is among the fastest-growing causes of death worldwide and represents a significant and increasing healthcare burden. Despite this growing prevalence, many forms of kidney disease continue to have limited treatment options available for patients.[5],[6] Dimerix is uniquely focused on kidney diseases, with a pipeline designed to address significant unmet medical needs. The Company's lead program, DMX-200, is currently being evaluated in the fully recruited global ACTION3 Phase 3 clinical trial in patients with FSGS - a serious, rare kidney disease that can lead to kidney failure and the need for dialysis or transplantation. Dimerix is also advancing DMX-652 for Acute Kidney Injury, a condition associated with significant morbidity, mortality and healthcare costs worldwide. The Phase 2 clinical program is designed to evaluate the potential of DMX-652 in preventing kidney injury and preserving renal function, following cardiac surgery. Potential catalysts As Dimerix advances its pivotal, fully recruited ACTION3 Phase 3 trial for DMX-200 toward what is anticipated to be a major value-creating event if successful, the Company has simultaneously strengthened its growth profile through the recent acquisition of DMX-652 and its ongoing advancement into Phase 2 clinical development. Progress and positive outcomes from the DMX-652 development program have the potential to create substantial additional shareholder value, diversify Dimerix's clinical pipeline, and deliver multiple near- and medium-term catalysts for investors. The entry into the A$34 million[1] facility the subject of the Loan Agreements is expected to support these important clinical milestones and further strengthen Dimerix's position as a leading kidney disease-focused biotechnology company. Authorised for lodgement by the Board of Dimerix —END— For further information, please visit our website at www.dimerix.com. Follow Dimerix on LinkedIn and X About Dimerix Dimerix Limited (ASX: DXB) is a clinical-stage biopharmaceutical company focused on developing new therapies for kidney diseases with significant unmet medical need. The Company's lead program, DMX-200, is currently in Phase 3 clinical development for focal segmental glomerulosclerosis (FSGS), a serious and life-threatening rare kidney disease with limited treatment options. In addition, Dimerix is advancing a Phase 2 program in acute kidney injury (AKI), further strengthening its pipeline in high-need renal indications. With a growing network of five commercial partners supporting global development and future market access, Dimerix is committed to expanding its reach and delivering innovative treatments to as many patients as possible worldwide while creating long-term value for shareholders. For more information, please visit the company's website at www.dimerix.com. About DMX-200 in FSGS FSGS is a rare, serious kidney disorder characterised by progressive scarring (sclerosis) in parts of the glomeruli - the kidney's filtering units. This scarring leads to proteinuria, progressive loss of kidney function, and often end-stage renal disease. FSGS is increasingly understood to have an inflammatory component, with monocyte and macrophage activation contributing to glomerular injury. In the United States, more than 40,000 people are estimated to be living with FSGS, including both adults and children.[7] There are no therapies specifically approved for FSGS in the U.S., and disease management relies on non-specific immunosuppressive and supportive therapies. In patients with progressive or treatment-resistant FSGS, the average time from diagnosis to end-stage kidney disease can be as short as five years. Even among those who undergo kidney transplantation, disease recurrence occurs in up to 60% of cases,[8] underscoring the urgent need for new, disease-modifying treatments. DMX-200 is a chemokine receptor (CCR2) antagonist administered to patients already receiving an angiotensin II type I receptor (AT1R) blocker, the standard of care treatment for hypertension and kidney disease. DMX-200 is protected by granted patents in various territories until 2032, with patent applications submitted globally that may extend patent protection to 2042, in addition to Orphan Drug Designation granted in the United States, Europe, UK and Japan[9]. About DMX-652 in Acute Kidney Injury Acute kidney injury (AKI) is a prevalent and severe clinical syndrome of substantial unmet need. It can arise from several high-risk clinical settings including, most notably, cardiac surgery and sepsis and is characterised by a rapid decline in kidney function (within hours), often resulting in high morbidity and mortality. The current addressable patient population is estimated to be approximately 260,000 across the major markets of United States, Germany, France, Italy, Spain and United Kingdom per annum,[10],[11] making this indication a potential orphan designation. AKI represents a significant clinical burden. There are no approved therapies for AKI, which is associated with rapid kidney function decline within hours, increased risk of chronic kidney disease and long-term kidney complications. DMX-652 is a selective inhibitor of USP30 - a mitochondrial enzyme that slows the removal of damaged mitochondria. DMX-652, which is a small molecule delivered as an oral once daily capsule, is designed to support mitochondrial quality control in injured kidney cells, a mechanism indicated in the progression of AKI caused by ischaemia (lack of blood flow resulting in oxygen starvation), toxins or sepsis related causes, as well as in other renal and non-renal indications. The DMX-652 acquisition includes the composition of matter patent, an open IND in the US with a Phase 2 clinical trial protocol which has received approval to proceed by the US Food and Drug Administration (FDA), as well as sufficient pharmaceutical grade (GMP) drug product for the Phase 2 trial and all manufacturing methodology. The Phase 2 trial is designed to investigate DMX-652's potential to prevent kidney injury and preserve renal function. Dimerix Forward Looking Statement This release includes forward-looking statements that are subject to risks and uncertainties. Although management believes that the expectations reflected in the forward-looking statements are reasonable at this time, Dimerix can give no assurance that these expectations will prove to be correct. Readers are cautioned not to place undue reliance on forward-looking statements. Actual results could differ materially from those anticipated. Reasons may include risks associated with drug development and manufacture, risks inherent in the regulatory processes, delays in clinical trials, results of clinical trials, contractual risks, risks associated with patent protection, future capital needs or other general risks or factors, including but not limited to those factors outlined in the most recent Dimerix Limited Annual Report. Appendix 1 Key Terms of the Loan Facility Agreements Lenders Various independent and unrelated U.S. and Australia-based investors, as well as SKIPTAN Pty Ltd (A$2,000,000) and SKIPTAN Pty Ltd as Trustee for the P&M Meurs Family Trust (A$10,000,000) (collectively the "Lenders"). The SKIPTAN entities are each an associate of Mr Peter Meurs, a substantial shareholder of Dimerix, and a related party of Dimerix. Facility Collectively A$34 million[1] (of which 50% must be drawn down by Dimerix by 18 September 2026, and the remainder at Dimerix's discretion (in whole or in part) up to 31 March 2027). Dimerix has the option to take further commitments for up to a total of A$50m before March 2027. Dimerix may draw down on the facility by providing a drawdown notice to the Lender not less than 15 business days prior to the proposed drawdown date (or 5 business days for the first draw down of 50% of the amount committed). If Dimerix does not draw down the full facility amount by 31 March 2027, the balance lapses and cannot be drawn upon. Term Facility amount drawn down and received by Dimerix plus accrued interest to be repaid by 17 January 2028 (refer to repayment term below). Use of Funds Extend cash runway to support: DMX-200 expanded access programs; DMX-200 commercial manufacturing readiness; clinic-ready pipeline expansion in rare/renal disease, including DMX-652. Interest rate 10% per annum, compounding annually: applies only to the facility amount drawn down and received by Dimerix. No interest shall accrue on the milestone participation (refer below). Security The unrelated Lenders (being all Lenders other than the SKIPTAN entities) hold the benefit of security granted by the Company and Dimerix Biosciences Pty Ltd pursuant to a General Security Deed consistent with industry standard. The SKIPTAN entities, as related parties, remain unsecured pending Dimerix obtaining a waiver of Listing Rule 10.1 from ASX, or shareholder approval to grant security to the Lender in line with the announcement dated 17 July 2026.[2] The security interest, as applicable, will only apply to principal drawn down by Dimerix and accrued interest. It will not apply to the milestone participation (refer below), which will remain an unsecured obligation of the Company. Repayment Dimerix may repay the facility amount received any time until the repayment date (17 January 2028), with a commensurate reduction in earned interest (10% p.a. compounding annually to the repayment date). Milestone participation Unsecured right of the Lenders, including any new lenders, to an aggregate of 30% of each milestone payment received by Dimerix under DMX-200 commercial license agreements, capped in aggregate at 2.0x the amount drawn down and received by Dimerix from the Lenders. Each Lender, including any new lender, is to participate in each milestone payment in their respective proportion of the overall funding drawn down. Other terms The Loan Agreement otherwise contains terms typical for an agreement of this kind, including representations and warranties from the Company, default provisions (including without limitation in respect to the occurrence of an insolvency event, a material adverse change or breach of obligations by the Company under the Loan Agreement) and undertakings by the Company, including to preserve the potential for receipt of milestones as described above. SOURCE Dimerix Limited