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

Highlights:

• FDA confirms inclusion of adolescent children (12-17 years old) in ACTION3 global Phase 3 FSGS study is appropriate, increasing the total addressable market for DMX-200 if approved
• FSGS is one of the leading causes of kidney failure in children, with 20% of all child nephrotic syndrome cases caused by FSGS
• Dimerix is also in discussion with the European Medicines Agency (EMA) regarding a Paediatric Investigation Plan (PIP), which is a regulatory requirement prior to seeking market approval in Europe, the outcome of which is expected in calendar year 2023
• 90 adult patients currently recruited in ACTION3 phase 3 pivotal clinical trial of DMX-200 in the treatment of focal segmental glomerulosclerosis (‘FSGS’) kidney disease
• 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
• All activated sites will continue to recruit suitable patients for Part 2 of the ACTION3 trial
• 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
• DMX-200 has previously received Orphan Drug Designation with the FDA, EMA and UK, allowing potential fast track of commercialisation if successful

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 December 21, 2022: AUD 0.15) 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 trials 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 11 countries and has received FDA IND approval in the US. The Company has completed the recruitment of 72 patients for Part 1 of the study and has started the recruitment for Part 2.
• The revamp in public health policy in the renal space along with FDA approval for accepting surrogate endpoints such as proteinuria and eGFR as registration endpoints in kidney diseases is fuelling the growth of the US FSGS market and is a major tailwind for Dimerix.
• In addition to FSGS, Dimerix is developing DMX-200 for the treatment of Diabetic Kidney Disease and acute respiratory distress syndrome in patients with COVID-19. 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.
• On December 13, 2022, the Company announced that the initial results of CLARITY 2.0 investigator-led study on DMX-200 as a treatment for COVID-19 show that the drug is safe to administer to patients with COVID-19. However, its efficacy could not be proven since the number of patients enrolled for the study was small. Expediting further research and commercialization process for DMX-200 as a treatment for COVID-19 is not a current priority for the Company since the market scope for new Covid-19 treatments has diminished considerably since 2019-20.

Highlights:

• A significant milestone has been achieved with the first 72 patients (Part 1) now recruited in ACTION3 phase 3 pivotal clinical trial of DMX-200 in the treatment of focal segmental glomerulosclerosis (‘FSGS’) kidney disease
• FSGS is a rare disease with no existing registered treatment options specifically for sufferers1
• 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
• All recruited patients complete background medication stabilisation period before being re-screened and randomised to receive either drug or placebo
• Part 1 interim analysis, which will assess proteinuria reduction in patients on DMX-200 versus placebo at week 35, is anticipated in the latter half of 2023
• The trial has two interim data analysis points, the second of which may enable accelerated marketing approval
• The trial is being performed at over 70 clinical sites across 11 different countries
• All activated sites will continue to recruit suitable patients for Part 2 of the ACTION3 trial, also allowing for any screen failures or patient dropouts
• Orphan drug designation received, allowing potential fast track of commercialisation if successful

Key Highlights

• Dimerix raises A$2.5 million through a strongly supported Placement to new and existing sophisticated and professional investors
• Funds raised will predominantly be used to develop DMX-700 through value inflection points