Dimerix Limited

Highlights:

Operating Results:

• The loss for the Group for the half‐year ended 31 December 2022 after providing for income tax amounted to $9,609,019 (31 December 2021: $6,466,900)

The half‐year ended 31 December 2022 operating results are attributed to the following:

• Research and development expenditure of $8,587,501 (31 December 2021: $5,241,129)
• Corporate and administration expenses of $1,060,880 (31 December 2021: $1,266,903)

Highlights:

• Arrowhead is updating its coverage on Dimerix Limited (“Dimerix” or the Company’) with a fair value bracket of AUD 0.36- AUD 0.44 (Share Price on February 21, 2023: AUD 0.12) based on rNPV, NPV, and Comparable Company Valuation
• Dimerix Limited is a Melbourne, Australia-based clinical-stage biopharmaceutical company with a portfolio of drug candidates for inflammatory causes of kidney and respiratory diseases. The Company is listed on the Australian Securities Exchange (ASX: DXB)
• The Company’s lead drug candidate DMX-200 is in Phase 3 trials for the treatment of Focal Segmental Glomerulosclerosis (FSGS”), which is a rare kidney disease with no approved treatment anywhere in the world. DMX-200 was granted Orphan Drug Designation for FSGS in both the US and Europe because it addresses a very niche, underserved market with no effective treatment
• DMX-200 is one of only two drug candidates that are currently undergoing Phase 3 trial as a treatment for FSGS and the other drug candidate (Sparsentan being developed by Travere Therapeutics) is a potential complement to DMX-200 in the treatment of FSGS. DMX-200’s Phase 3 clinical study spans across 11 countries and has received FDA’s investigational new drug approval in the US. The recruitment of patients for Part 1 of the study is now complete and the Company has now started to recruit an additional 72 patients for Part 2 of the study, with 24 patients already recruited as of February 8, 2023
• Clinical data related to DMX-200’s clinical study demonstrates a strong safety profile and efficacy. The Data Safety Monitoring Board (“DSMB”) meeting in February 2023 noted no safety concerns with DMX-200’s Phase 3 clinical trial and the US FDA recently agreed that the inclusion of adolescent children in Phase 3 clinical trial is appropriate
• The Company is in discussions with major international pharmaceutical companies for potential commercial partnerships for DMX-200. The Company has also developed manufacturing capability through an FDA-approved global contract manufacturing organization based in the US and has completed commercial-scale batch manufacturing for DMX-200 through this partner
• In addition to FSGS, Dimerix is developing DMX-200 for the treatment of Diabetic Kidney Disease. Dimerix is also developing DMX-700 as a drug candidate for Chronic Obstructive Pulmonary Disease. On July 4, 2022. Dimerix released new data showing strong efficacy of DMX-700 in a preclinical model of COPD. Both DMX-200 and DMX-700 were identified using Dimerix’s proprietary Receptor-HIT technology. In addition to identifying new drugs, this proprietary technology also helps repurpose existing drugs for different indications

Highlights:

• Early access to forecast FY23 R&D Tax Incentive (RDTI) provides Dimerix with immediate funds, strengthening its financial position to continue executing upon its Phase 3 FSGS kidney clinical trial

Highlights:

• Scheduled independent Data Safety Monitoring Board (DSMB) review, evaluating the available study data for participant safety, study conduct and progress, has been successfully completed
• The DSMB recommends the ACTION3 clinical trial continue unchanged
• DSMB has noted no safety concerns to date, which is entirely consistent with the existing and growing strong safety profile of DMX-200
• The trial has two interim data analysis points, the second of which may enable accelerated marketing approval
• ACTION3 Part 1 interim analysis, which will assess proteinuria reduction of the first 72 patients on DMX-200 versus placebo at week 35, is anticipated in the latter half of calendar year 2023
• Patient recruitment continues to progress well, with 96 enrolled patients as at 08 February 2023 (up 100% since 27 October 2022) across 70 active sites
• FSGS is a rare kidney disease with no existing approved treatment options specifically for sufferers
• Total global FSGS market was valued at US$12.6 billion in 2022 with a CAGR of 8.2%, driven by approximately 220,000 FSGS sufferers across the 7 major markets and premium orphan drug pricing

Highlights:

• ACTION3 FSGS Phase 3 clinical trial Part 1 recruitment achieved
• ACTION3 FSGS Phase 3 clinical trial currently recruited 92 patients globally
• Dimerix received $6.0M R&D Tax Incentive Rebate
• ACTION3 Part 1 interim analysis, which will assess proteinuria reduction of the first 72 patients
• on DMX-200 versus placebo at week 35, is anticipated in the latter half of calendar year 2023
• FDA confirms inclusion of paediatrics in ACTION3 trial appropriate
• CLARITY 2.0 COVID-19 trial primary endpoint outcome announced
• Dimerix presented at AusBioInvest, highlighting FSGS ACTION3 program
• Dimerix presented at BioEurope partnering conference, the largest gathering of global pharma companies outside the US
• Non-Executive Chairman resigned
• Cash position of $5.7 million at 31 December 2022
• Net operating cash flow for the December quarter was -$375,000