Iq-ai Ltd Regulatory News (IQAI)

IQ-AI Ltd

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

Imaging Biometrics granted FDA "Fast-Track"

Dec 19, 2023 - Imaging Biometrics, LLC (IB), a wholly owned subsidiary of IQ-AI Ltd (LSE: IQAI), is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted "Fast-Track" designation for oral gallium maltolate (GaM), IB's therapeutic for the treatment of adult patients with relapsed or refractory glioblastoma (GBM), IDH-wildtype.

The FDA's decision to grant Fast-Track status reflects the urgency and unmet medical need associated with GBM. Receiving both Fast-Track and Orphan Drug designations from the FDA for oral GaM validates the importance of advancing the development of this treatment for these patients.

Fast-Track designation offers an accelerated review process with the FDA via increased communication and collaboration during the development process. IB is now well positioned to utilize this streamlined and efficient process to bring this promising agent to the market as quickly as possible.

"We are very pleased to receive Fast Track designation," said Trevor Brown, CEO of IQ-AI. "This is an important milestone as well as a commercial accelerator, and we are firmly committed to working closely with the FDA to expedite the clinical development of oral GaM."

--ENDS-

The Directors of the Company accept responsibility for the contents of this announcement.

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