Ann: Shareholder Update, page-2

This is a fantastic update. To me, the additional info here puts up an urgent case for the need for IRX211. Perhaps a fast tracking to get all relevant approvals swiftly once the results from the trials are favorable.

"On August 28, 2024, manufacturers of Transmucosal Immediate-Release Fentanyl (“TIRF”) medicines announced that production of all TIRF medicines would be discontinued on September 30, 2024. This relates to the FDA Risk Evaluation and Mitigation Strategy (‘REMS’), and manufacturers have confirmed that they will no longer accept new enrollments for patients, prescribers, or pharmacies within the REMS program.

TIRF medications, including fentanyl, are highly effective for managing severe pain, but their potent effects pose serious risks, such as overdose and death, particularly when prescribed to patients who are not opioid tolerant. The FDA REMS program aims to ensure these medications are used safely, focusing on restricting access to patients who meet strict criteria. This increased regulation provides an opportunity for IRX-211 to enter the market with a differentiated profile, especially if it can offer similar or improved efficacy in managing breakthrough pain but with a more favorable safety and risk profile.

IRX has positioned IRX-211 as a solution that addresses the limitations of current treatments under the REMS program. With stricter guidelines surrounding the prescription of fentanyl-based products, healthcare providers and patients are seeking alternative options for breakthrough cancer pain management that reduce the complexity of opioid-based treatment regimens. IRX-211, if demonstrated to be both effective and safer than TIRF medications, has the opportunity to capture significant market share, particularly among patients who are not suitable candidates for fentanyl-based therapies.

The latest discontinuation announcement reinforces the Company’s positioning in an ever-evolving market landscape in which IRX-211 may offer a more accessible and effective treatment option for patients while meeting the FDA’s evolving standards"