ENTITLEMENT OFFER PROSPECTUS
Welcome to InhaleRx Ltd
InhaleRx Ltd (IRX) is an Australian biotechnology company specialising in precision medicine delivered through inhalation.
InhaleRx is actively pursuing New Drug Approvals (NDAs) with the U.S. Food and Drug Administration (FDA) in both Pain and Mental Health Management.
Indications selected have been carefully considered, given there is both a clinical gap and a significant commercial opportunity.
Why Inhaled therapies?
There are many treatment options available to patients that suffer from chronic conditions, but there’s very few safe and effective rapid onset treatment options.
These medications can be used as an adjunct to chronic therapies, or in some cases may replace the need for use of medications to manage symptoms.
- Application of treatment and Mechanism of Action
- Inhaled
- Oral
- Transdermal
- Injectable
- Onset of Action^
- Fast
- Slow
- Slow
- Fast
- Offset of Action^
- Fast
- Slow
- Slow
- Fast
- Bioavailability
- Fast
- Low
- Low
- High
- Not impacted by 1st pass metabolism
- Ease of patient use
- Suitable for Acute Indications
Clinical Assets Under Development – IRX-211
Breakthrough Cancer Pain Solution
IRX-211 aims to revolutionise the management of Breakthrough Cancer Pain (BTcP) with a non-opioid, rapid-onset inhaled therapy.
Proven Safety
Phase I clinical trials for IRX-211 have been completed with no significant adverse events, showcasing strong safety data.
Regulatory Pathway Defined
The FDA has provided supportive feedback positioning IRX-211 for expedited regulatory approval and commercialisation.
Massive Market Potential
With a $9 billion addressable market in cancer pain by 2028, IRX-211 targets a significant unmet need in pain management.
Global Accessibility
FDA approval paves the way for subsequent approvals in Europe (EMA) and Australia (TGA), enabling broad patient access.
Scalable Demand
Addressing the needs of 1.8 million cancer patients in the U.S. alone, IRX-211 meets the growing demand for effective, non-opioid therapeutic options.
Assets under development – IRX-616a
Innovative Panic Disorder Therapy
IRX-616a is positioned to be the first FDA-approved inhaled medication for Panic Disorder, offering a novel treatment avenue.
Addressing an Urgent Need
With the COVID-19 pandemic increasing the prevalence of anxiety disorders by 25%, IRX-616a addresses a growing health crisis.
Unmet Market Demand
Existing treatments like SSRIs are plagued by side effects, such as disrupted sleep and increased suicidality risks, highlighting the need for alternatives like IRX-616a.
Unique Market Advantage
The lack of competition in inhaled medications for Panic Disorder strengthens IRX-616a’s commercial prospects.
Large Market Opportunity
The total addressable market for anxiety and depression treatments is projected to reach $13.3 billion by 2027.
Strategic Regulatory Plan
An IND has been submitted, and FDA approval would lead to further approvals by the EMA and TGA, enhancing its global reach.
