IQ-AI Regulatory News (IQAI)

May 20, 2024

IQ-AI Ltd

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

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

For the Treatment of Pediatric-Type Diffuse High Grade Glioma ("HGG")

Further to the announcements made on 8 November 2023 and 10 May 2024, 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 pediatric-type diffuse HGG. IB-003 is the Company's lead drug candidate, oral gallium maltolate ("GaM").

Recently, the FDA granted RPDD to GaM for the treatment of atypical teratoid rhabdoid tumor ("ATRT").

Pediatric-type diffuse HGG, which now consists of four molecularly distinct subtypes according to the 2021 World Health Organization Classification of the Central Nervous System, fifth edition ("2021 WHO CNS5"), falls within this population. Prior to the WHO reclassification, these tumors were referred to as pediatric glioblastoma. The four subtypes include diffuse midline glioma, diffuse hemispheric glioma H3 G34-mutant, diffuse pediatric high-grade glioma H3 wildtype and IDH wildtype, and infant-type hemispheric glioma.

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. Like ATRT, pediatric-type diffuse HGG meets this criterion. These cancers have a poor prognosis primarily due to the early dissemination of cancer cells through the cerebrospinal fluid. Moreover, treating these tumors is especially difficult due to their location and the challenges of surgically resecting tumor tissue.

This RPDD designation request also leveraged data obtained from the pre-clinical study by Mona Al-Gizawiy, PhD in the laboratory of Kathleen Schmainda, PhD at the Medical College of Wisconsin. As announced on 27 June 2023, the study showed growth inhibition and a survival benefit from treatment with IB-003. Specifically, median overall survival for pediatric glioblastoma was 21 days in the control group and 49 days in the treated group.

Having multiple RPDDs offers both strategic and financial advantages in advancing treatment for rare pediatric diseases. Of these, priority review vouchers ("PRV") are the most significant. Upon new drug application ("NDA") approval by the FDA, a sponsor becomes eligible for a PRV. The PRV can then be redeemed to obtain a priority review for another NDA, or they can be sold or transferred to other companies.

"This second Rare Pediatric Disease Designation for IB-003 reflects our commitment to address the needs of children affected by these conditions," said Trevor Brown, CEO of IQ-AI Ltd. "Building upon these designations, we are exploring ways to accelerate and expand the application of IB-003."

--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.