Rare Pediatric Disease Designation Granted to GaM

May 10, 2024

IQ-AI Ltd

(“IQ-AI” or the “Company”)

Imaging Biometrics Announces U.S. FDA Rare Pediatric Disease Designation Granted to GaM

For the Treatment of atypical teratoid rhabdoid tumor (“ATRT”)

Further to the announcement made on 8 November 2023, Imaging Biometrics (“IB”), Elm Grove, WI, a wholly owned subsidiary of IQ-AI Ltd (LSE:  IQAI), today announces that the U.S. Food and Drug Administration (the “FDA”) has granted Rare Pediatric Disease Designation (“RPDD”) to IB-003 for the treatment of ATRT. IB-003 is the Company’s lead drug candidate, oral gallium maltolate (“GaM”).

Rare pediatric diseases are defined by the FDA as serious or life threatening that affect less than 200,000 people under 18 years of age. ATRT is a highly aggressive tumor that is associated with dismal outcomes. It is well acknowledged that there are limited treatment options for children with ATRT.

IB-003 has demonstrated promising potential in pre-clinical and clinical settings for the treatment of multiple brain tumors. As announced on 27 June 2023, a pre-clinical study conducted by Mona Al-Gizawiy, PhD in the laboratory of Kathleen Schmainda, PhD at the Medical College of Wisconsin, showed ATRT growth inhibition and a survival benefit from treatment with IB-003. Specifically, median overall survival for ATRT was 89 days in the control group and 170 days in the treated group.

If market approval for IB-003 is obtained under this RPDD, IB may qualify for a priority review voucher (“PRV”). A PRV can be redeemed to obtain priority review for subsequent marketing applications, or the PRV can be sold or transferred to another company.

“Receiving this RPDD from the FDA underscores the unmet clinical need for children with ATRT,” said Trevor Brown, CEO of IQ-AI, Ltd. “It is another critical milestone in our planning and development of IB-003,” Mr Brown added.

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–ENDS–

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

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About Imaging Biometrics® LLC:  IB is a wholly owned subsidiary of IQ-AI Limited, (LON: IQAI), 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.