Last checked at 9 Oct 2023 07:00
IQ-AI Ltd
("IQ-AI" or the "Company")
IQ-AI Announces Orphan Drug Designation Status
FDA grants orphan status to Gallium Maltolate for treating ATRT
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Imaging Biometrics, LLC (IB), a wholly owned subsidiary of IQ-AI Ltd (LSE: IQAI), today announces the U.S. Food and Drug Administration (US FDA) has granted Orphan Drug Designation (ODD) for gallium maltolate (GaM) for the treatment of atypical teratoid rhabdoid tumour (ATRT). Currently the prognosis for patients with ATRT is dismal due to the lack of effective treatments.
This decision by the FDA is the second orphan designation granted to GaM this year.
"This additional orphan drug determination by the FDA is another regulatory milestone towards providing an effective, well-tolerated treatment alternative for patients with limited options, and we look forward to sharing additional information on our clinical data as the phase 1 nears completion," said Trevor Brown, CEO of IQ-AI.
Further to the announcement made on 18 August 2023, IQAI has cancelled the 396,241 ordinary shares issued to the Mayo Clinic. Following this cancellation, the issued share capital is now 182,225,149 ordinary shares.
The above figure of 182,225,149 may be used by shareholders in the Company as the denominator for the calculations by which they will determine if they are required to notify their interest in, or a change in their interest in, the share capital of the Company under the FCA's Disclosure and Transparency Rules.
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The Directors of the Company accept responsibility for the contents of this announcement.
For further information, please contact:
IQ-AI Ltd Trevor Brown/Vinod Kaushal/Brett Skelly/Michael Schmainda Tel: 020 7469 0930 |
Peterhouse Capital Limited (Financial Adviser and Broker) Lucy Williams/Heena Karani Tel: 020 7220 9797 |
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.