Promising Preliminary Results of Phase 1 Study

IQ-AI Ltd

("IQ-AI" or the "Company")

Imaging Biometrics Announces Promising Preliminary Results of Phase 1 Study

Oral Gallium Maltolate Demonstrates Early Signals of Efficacy

IQ-AI is pleased to provide the following update on its wholly-owned subsidiary, Imaging Biometrics LLC.

The study on patients with recurrent/refractory glioblastoma is nearing completion, with three subjects left to be enrolled in the expansion phase.

The agent, oral GaM, is taken daily and has demonstrated excellent tolerability, with no serious adverse events reported.

Among the 23 subjects with evaluable data, early signs of efficacy have been observed, with an overall survival ("OS") of 32 months. 

Elm Grove, WI, April xx, 2025 - Imaging Biometrics, LLC (IB) today announced promising preliminary data from their ongoing Phase 1 clinical dose escalation study of oral GaM in patients with recurrent/refractory glioblastoma. This marks the first in-human study results of GaM for glioblastoma.

Overall survival for all glioblastoma patients is 8-9 months, but has been shown to be prolonged with redo surgery to up to 20 months. Of the 23 subjects evaluable in this Phase 1 study, 19 underwent redo surgeries.

Among evaluable glioblastoma patients in this Phase 1 trial, overall survival is 14 months from GaM treatment intitiation and 32 months from the time of initial diagnosis. This takes into account all the significant factors such as age, methylation (MGMT) status, previous surgical resections, etc. This represents a positive signal of response.

"While this data is preliminary and further work is required, we are very encouraged by the promising early signals suggesting prolonged overall survival and potential anti-tumor activity with GaM," said Trevor Brown, CEO of  IQAI.

Data also indicate that trial patients experienced a progression-free-survival ("PFS") of 2 months without tumor worsening. This is comparable to the current PFS of 1-2 months for recurrent glioblastoma patients undergoing standard therapy. While these findings suggest that PFS is not changed compared to current numbers, patients may have benefitted from disease stability as evidenced by their prolonged overall survival.

It should also be noted that determination of PFS was based on standard radiologic (RANO) response criteria, which often cannot reliably distinguish tumour progression from effects due to treatment. Advanced quantitative imaging, such as what is provided by IB's FTB maps, are also being evaluated as a more accurate way to assess PFS and may lend further insight on the response to treatments such as GaM.

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About Imaging Biometrics® LLC:  IB is a wholly-owned subsidiary of IQ-AI Limited, (LON: IQAI) (OTCQB: IQAIF), and focuses on delivering quantitative imaging platforms and therapeutics that transform how clinicians diagnose and treat patients more efficiently and effectively. For more information about Imaging Biometrics, visit the company's website at www.imagingbiometrics.com. Follow IB on Twitter, @IQAI_IB.