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InhaleRx Secures $38.5M Funding to Advance Inhaled Therapies for Cancer Pain and Panic Disorder

• InhaleRx has secured $38.5 million in funding from Clendon Biotech Capital to advance its inhaled therapies, IRX-211 and IRX-616a, through Phase 2 clinical trials. • IRX-211 is being developed for breakthrough cancer pain in opioid-tolerant patients, offering rapid relief through precise medication delivery. • IRX-616a, a CBD-based medicine, is designed to provide fast and effective relief for individuals suffering from panic disorder. • The funding will also address FDA requirements for the IRX-616a Investigational New Drug (IND) application, ensuring patient safety standards.

InhaleRx, an Australian healthcare company, has entered into a funding agreement with Clendon Biotech Capital to receive up to $38.5 million. This investment will support the clinical development of InhaleRx's inhaled therapies, IRX-211 and IRX-616a, through Phase 2 clinical trials.

Funding to Propel Clinical Development

Clendon Biotech's funding will cover all costs associated with the IRX-211 and IRX-616a drug development plans, including non-clinical work and trial drug manufacturing. This financial backing is expected to enable InhaleRx to meet the requirements of the U.S. Food and Drug Administration (FDA) related to its recent Investigational New Drug (IND) application for IRX-616a.

Addressing Breakthrough Cancer Pain with IRX-211

IRX-211 is under evaluation for the treatment of breakthrough cancer pain (BTcP) in opioid-tolerant patients. BTcP is characterized by sudden, intense pain episodes that occur despite otherwise controlled chronic cancer-related pain. Conventional treatments often fall short due to delayed onset of action or suboptimal dosing.
The IRX-211 treatment delivers a precise dose of medication designed to provide rapid onset relief, ensuring quick absorption and action when needed most. The next stage of testing for IRX-211 is a planned Phase 2 study to evaluate its efficacy and safety, designed to replicate the registration trials used for fentanyl products, the only FDA-approved drugs for treating BTcP.

Rapid Relief for Panic Disorder with IRX-616a

IRX-616a is a device-drug combination designed to deliver cannabidiol (CBD)-based medicine quickly and safely into circulation. This ensures excellent bioavailability and a rapid onset action for near-immediate relief from acute panic attacks. Current treatments for panic disorder (PD) often have a delayed onset of action or can be difficult to administer during an attack, an issue the InhaleRx treatment is designed to overcome.

Management Perspective

InhaleRx CEO Darryl Davies stated that the partnership with Clendon is a transformative step in securing the company’s ability to execute its clinical development strategy. He added that while this partnership provides vital support for their clinical development program, they will continue to explore opportunities to fund their broader operational needs and ensure the long-term success of the company.

Financial Details of the Agreement

The funding agreement includes an interest rate of 15% per annum, with repayment terms tied to the completion of each project. Additionally, CBC will receive options in InhaleRx representing 19.9% of the ordinary shares on issue. InhaleRx must repay the money owed in cash but may use the proceeds from the exercise of the options to make the repayments. The facility will be secured by a general security deed granted by InhaleRx in favor of CBC over all of its assets and undertaking.
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Reference News

[1]
InhaleRx secures up to $38.5m in funding for clinical trial program | Cannabiz
cannabiz.com.au · Oct 18, 2024

InhaleRx secures A$38.5 million from Clendon Biotech Capital for Phase 1 and 2 clinical development of cannabinoid drugs...

[2]
InhaleRx procures $38.5m in funding from Clendon Biotech to progress inhaled therapies
smallcaps.com.au · Oct 18, 2024

InhaleRx (ASX: IRX) secures $38.5M from Clendon Biotech Capital to fund IRX-211 (breakthrough cancer pain) and IRX-616a ...

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