IQ-AI Ltd (LSE:IQAI, OTCQB:IQAIF) said its Phase 1 Clinical Trial for IB003, its gallium maltolate children's brain cancer treatment, is in the final stages.
As soon as all the results are available, an End of Phase 1 (EOP1) meeting will be held with the US Food and Drug Administration (FDA).
“The EOP1 meeting is critical. In an FDA Fast Track Designated development program, FDA resources are assigned to help abbreviate various aspects of the development pathway, including offering strategic guidance for the phase 2 protocol that is currently being drafted.
“We anticipate this will happen before the end of this year.”
IQ-AI added that it will be introducing the next software release of IB Clinic later in the third quarter.
This release includes important new features and enhancements requested by current and prospective clients, along with some necessary upgrades in cybersecurity and general updates to the code base.
Of most significance, will be the ability to post-process Spin and Gradient Echo (SAGE) data, said the statement.
Revenue in the half year to end June 2024 was £444,000 with interim losses of £274,000.