Australian drug development company InhaleRx Limited (ASX: IRX) has successfully secured a $38.5 million funding agreement with Clendon Biotech Capital Pty Ltd to accelerate the development of its novel inhaled medications for cancer pain and panic disorder.
The company recently completed its first drawdown of $247,500 under the facility, marking a significant milestone in its clinical development program. These initial funds will support batch manufacturing and stability testing of trial drugs for IRX-211, with GMP partner Ab Initio Pharma in Sydney handling the manufacturing process.
Strategic Funding Structure
The $38.5 million facility, established in October 2024, is structured around project milestones and designed to be non-dilutive to shareholders. This arrangement will fully fund the clinical development program for both IRX-211 and IRX-616a through to the completion of Phase 2 clinical trials, including all necessary non-clinical toxicology studies.
CEO Darry Davies emphasized the strategic importance of the partnership: "This funding arrangement with Clendon not only provides the capital needed to advance our clinical programs but does so in a way that preserves shareholder value while accelerating our path to market."
Focus on Breakthrough Cancer Pain
IRX-211, the company's lead candidate, is a non-opioid inhaled treatment designed to provide rapid-onset relief for Breakthrough Cancer Pain (BTcP). The company aims to achieve 'First Patient First Dose' in Q3 2025.
Breakthrough cancer pain represents a significant unmet medical need, characterized by temporary flares of severe pain that occur despite background pain medication. Current treatments often involve rapid-acting opioids, which carry risks of respiratory depression, dependence, and other side effects.
InhaleRx's approach leverages inhaled delivery to provide faster onset of action compared to oral medications, potentially offering improved pain control with fewer systemic side effects.
Expanding Mental Health Applications
The company's second candidate, IRX-616a, targets panic disorder, a condition characterized by recurrent, unexpected panic attacks that can significantly impair quality of life. Current treatments typically include selective serotonin reuptake inhibitors (SSRIs) and benzodiazepines, both of which have limitations in onset of action or side effect profiles.
By developing an inhaled formulation, InhaleRx aims to provide more rapid symptom relief during acute panic episodes while potentially reducing systemic exposure and side effects.
Regulatory Strategy and Market Potential
InhaleRx is pursuing U.S. FDA approval via the 505(b)(2) pathway, which allows the company to rely partly on previously established safety and efficacy data for approved drugs, potentially streamlining the development process.
The company's board views the Clendon partnership as pivotal to its growth strategy and believes that IRX-211 has the potential to transform the treatment landscape for cancer pain, addressing a global market with significant unmet needs.
Manufacturing and Clinical Timeline
With the initial funding now secured, InhaleRx is focusing on batch manufacturing and stability testing for IRX-211. The company has completed necessary adjustments for trial drug manufacturing to meet FDA requirements.
The expanded scope of clinical trials is designed to enhance the company's market positioning and expedite the path to commercialization. Following the Phase 2 trials, the funding agreement is structured to support development through to Phase 3 readiness.
"Our partnership with Ab Initio Pharma ensures we maintain the highest quality standards in our manufacturing process, which is critical for regulatory approval," noted Davies. "We're on track to meet our clinical milestones and remain focused on building InhaleRx into a global leader in inhaled therapies for pain and mental health."
The company's year-to-date stock performance shows a 28.57% decline, with a current market capitalization of A$5.34 million. Despite these challenges, technical sentiment signals indicate strong buy recommendations from market analysts.
