Immuron Ltd Engages Pullan Consulting for IMM-529 Partnering Strategy

Immuron engages Pullan Consulting to advance IMM-529 partnering strategy

Immuron (ASX: IMC; NASDAQ: IMRN) has engaged life sciences advisory firm Pullan Consulting to secure a strategic partnership for IMM-529, its investigational therapy for Clostridioides difficile infection (CDI).

Announced from Melbourne on 6 July 2026, the engagement targets a partner to support clinical development through regulatory approval and commercialisation. The commercial backdrop is material: an opportunity assessment by Lumanity projects base case yearly revenue for IMM-529 at US$400M.

Why the Pullan Consulting engagement matters

Pullan Consulting is a life sciences advisory firm with a track record of executing between five and twelve partnering transactions annually over the past 20 years. The firm specialises in guiding biotechnology and pharmaceutical companies through the full partnering process.

For investors, the appointment signals that Immuron is actively pursuing value realisation for IMM-529 rather than holding a dormant asset. Pullan’s expertise is expected to support Immuron in maximising the value of the programme while advancing it toward commercialisation.

The firm’s mandate spans:

• Strategy development

• Partner identification

• Negotiation

• Transaction execution

The Company is seeking partners to advance clinical development of IMM-529 through to regulatory approval and commercialisation, with Pullan Consulting positioned to identify and execute a suitable deal.

Understanding Clostridioides difficile infection

CDI is a healthcare-associated gut infection linked to the widespread use of broad-spectrum antibiotics. When antibiotics disrupt the gastrointestinal microbiota (the community of microbes living in the gut), patients become susceptible to opportunistic pathogens such as C. diff.

A paradox sits at the centre of the problem. Treatment of CDI also relies on antibiotics, and this heavy reliance does not allow the gut flora to regenerate, predisposing patients to relapsing CDI.

The scale of the unmet need is significant:

• CDI affects over 400,000 people in the US annually

• It contributes to over 30,000 deaths in the US each year

• It was deemed an “urgent threat” in the Center for Disease Control and Prevention’s 2019 report on antibiotic resistance

• It is currently the most common pathogen in healthcare-associated infections

The result is a large, underserved market with an urgent call for new therapeutics that reduce or replace antibiotics.

What makes IMM-529 different

IMM-529 is an orally delivered polyclonal antibody derived from hyperimmune bovine colostrum (HBC), developed in collaboration with Dr Dena Lyras and her team at Monash University. Dairy cows are immunised to generate colostrum containing antibodies that target three essential C. diff virulence components.

This unique 3-target approach neutralises Toxin B (TcB), targets the spores, and targets the surface layer proteins of the vegetative cells.

The differentiation against existing therapy is notable. FDA-approved monoclonal antibody Bezlotoxumab was developed to prevent recurrence by neutralising toxin B, the major driver of recurrent disease. By contrast, IMM-529’s polyclonal antibodies offer multivalent defence compared with monoclonal single-epitope antibodies.

IMM-529 also holds an advantage over current standard of care antibiotic treatments that disrupt microbiota. It decolonises the gut facilitating clearance of the pathogen, recovery of the microbiome and prevention of recurrent infection.

The 3-target approach has yielded promising results in pre-clinical infection and relapse models.

Importantly, IMM-529 antibodies cross-react with whole cell lysates of many different human strains of C. diff, including hypervirulent strains. To the Company’s knowledge, IMM-529 is, to date, the only investigational drug that has shown therapeutic potential in all three phases of the disease.

FDA-cleared IND and a Phase 2-ready programme

Immuron holds U.S. Food and Drug Administration (FDA) approval for the IMM-529 Investigational New Drug (IND) application. IND 32095 covers clinical development of IMM-529 as a product to specifically prevent or treat CDI in a Phase 2 clinical trial.

FDA approval for the IMM-529 trial was secured alongside continued commercial momentum, with Immuron’s oral delivery platform demonstrating a safety profile across more than 700 patients in prior studies.

Several trial-readiness milestones have been completed:

1. Completed an Investigational Brochure and clinical protocol

2. Secured a principal investigator and three Australian sites

3. Confirmed eligibility for Australia’s Clinical Trial Notification (CTN) fast-track scheme

4. Manufactured and released drug product for clinical trial supply

The trial protocol is for a randomised, double-blind, placebo-controlled study of IMM-529 with Standard of Care (SOC) for the treatment of CDI in subjects with first episode or recurrent CDI. Up to 60 subjects will be enrolled, with subjects randomly assigned to IMM-529 + SOC or placebo + SOC in a 2:1 ratio across multiple sites. The primary objective is to evaluate safety and tolerability, with efficacy assessed through mortality rate, disease symptoms and recurrence rate for each treatment group.

The commercial opportunity and partnering upside

Lumanity’s opportunity assessment indicates that, if efficacious, IMM-529 would be positioned as early in the treatment algorithm as payers will allow. Up to ~98,000 patients would be eligible if the therapy is positioned at first recurrence, underpinning base case yearly revenue projected at US$400M. Oral dosing of IMM-529 was viewed as a positive by infectious disease experts.

Under a licensing model, the licensee typically funds development, registration and commercialisation costs. Such agreements commonly include upfront fees on execution, developmental milestone payments and royalties on product sales.

Terms from historical CDI-focused deals point to a wide range of possible structures: upfront payments of USD$1–$50 million, milestone payments of USD$25–$570 million, and royalties in the mid-to-high single digit percentage range. A successful development partnership for IMM-529 could, in the Company’s view, prove transformational for Immuron.

These figures are illustrative historical benchmarks showing a range of possible deal structures and do not represent terms for IMM-529.

What comes next for Immuron shareholders

Immuron is actively seeking a partner to advance IMM-529 clinical development through to commercialisation, with the Pullan Consulting engagement serving as the mechanism to identify and execute a deal.

The supporting trial infrastructure, spanning sites, a principal investigator, an approved protocol and released drug product, is already in place. That readiness positions the asset for rapid progression under a future partner, though no deal timing has been disclosed.

Ready to Explore the Investment Case Behind IMM-529?

Immuron’s engagement of Pullan Consulting marks a decisive step toward securing a strategic partnership for IMM-529, a Phase 2-ready CDI therapy underpinned by an FDA-cleared IND and a projected base case revenue opportunity of US$400M. With trial infrastructure already in place and a specialist partnering firm actively identifying candidates, the programme is positioned for meaningful near-term progress.

For a deeper look at the company’s pipeline, milestones, and commercial strategy, visit the Immuron investor centre to access the latest announcements and corporate updates.