Ann: Imugene EGM Presentation, page-31

  1. 94 Posts.
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    Lots to look forward in the near term, the way I read the upcoming key catalysts is as follows.

    1. Orphan Drug Designation for Azer-cel: Expected in February, this designation would further enhance Azer-cel's strong performance to date, adding a crucial regulatory milestone to its portfolio of achievements.

    2. Phase 1b Clinical Update: Scheduled for release in June, this timing suggests there may not be updates at the Transplantation and Cellular Therapy meeting. While this delay may be viewed as an opportunity to accumulate additional data, it is likely that the June update will include substantial results, potentially forming the foundation of the package intended for submission to the FDA for a registrational trial. It is plausible that results from the Australian patient are being incorporated, which could significantly impact media coverage in Australia, particularly if the outcomes are favorable.

    3. Vaxxinia Data Update: Expected in April, this update is anticipated to include results from the entire cohort. With Phase 2 trials planned for Q3, I'd hope Imugene provide detailed insights into the types of cancers treated, dosage regimens, and efficacy.

    4. Second Indication for NMIBC (Non-Muscle Invasive Bladder Cancer): Recruitment for this cohort appears to have commenced late last year, though the First Patient In (FPI) may not have been achieved yet. An announcement confirming the initiation of treatment would be an encouraging development.

    5. Oncarlytic's IT/IV Combination Data: Preliminary data from this program is anticipated around April. This is a highly significant update to watch for, given the implications for the broader strategy.


      It appears that Imugene may have sold or out-licensed its B-cell platform, redirecting efforts towards its remaining three platforms. This strategic realignment could reflect a prioritization of resources to optimize outcomes in the most promising areas of development.
 
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