Following are my questions to the IMU management team
1. Restoring Market Confidence
"What steps is the management team taking to rebuild market confidence, such as directors purchasing shares on-market or providing regular, transparent updates on trial progress to shareholders?"
2.Capital Raising and Share Consolidation
"When does the management anticipate the next capital raising? Are there plans to pair it with a share consolidation, and if so, how will this be structured to protect shareholder value?"
3. NASDAQ Listing Plans
"Does the company still intend to pursue a NASDAQ listing? If so, what is the current timeline, and what prerequisites remain to achieve this?"
4. Commercialization Strategy
"What is Imugene’s current commercialization strategy, and how has it evolved given the latest pipeline developments and market conditions?"
5.Partnerships and Out-Licensing
"Has Imugene engaged in substantive discussions with potential partners regarding the out-licensing of HER-Vaxx or PD1-Vaxx? How likely is a deal in the near term, and if no interest emerges, will shareholders be informed promptly?"
6. CF33 MAST Study Update
"Why has there been no update on the CF33 MAST study since November 6, 2023, when positive early signals were announced from the Phase 1 trial? What is the current status, and when can shareholders expect further data?"
7. Bile Tract Cancer Expansion Study
"When can we expect a trial update for the Bile Tract Cancer Expansion study, and what factors have delayed communication on this program?"
8. OnCARlytics Study Update
"Why has there been no update on the OnCARlytics study since October 26, 2023, when the first patient was dosed in the Phase 1 trial? What could we have the preliminary data for this trial?"
9. HER-Vaxx nextHERIZON Trial Update
"Why has there been no update on the HER-Vaxx nextHERIZON trial since May 10, 2022, when HREC approval was announced for the Phase 2 trial in Australia? Does this trial fail, due to fail to meet the endpoint, or fail to recruit enough patients, or for whatever other reasons"
10. PD1-Vaxx Trial Update
"Why has there been no update on the PD1-Vaxx trial since January 4, 2022, when the combination therapy with atezolizumab was added to the Phase Ib portion for non-small cell lung cancer patients? What is the current status? Does this trial fail, due to fail to meet the endpoint, or fail to recruit enough patients, or for whatever other reasons"
11. Supply Agreements with Roche and Merck KGaA
"What is the current status of the supply agreements with Roche and Merck KGaA? Management received bonuses tied to these deals, yet they appear to have delivered limited value to shareholders—can you explain their tangible benefits?"
12. Dr. Monil Shah’s Departure
"Why was there no announcement regarding Dr. Monil Shah’s departure as Chief Business Officer? Who has replaced him, and who is currently leading discussions with potential partners or big pharma? Can you candidly outline Dr. Shah’s contributions to Imugene, given his significant payroll in the past few years? In a 2022 investor seminar, he cited OnCARlytics as his reason for joining—does his exit, alongside the lack of OnCARlytics updates, suggest underwhelming results?"
