CatalystWireBeta

Orphan Drug Status to GaM and Total Voting Rights

In brief · summary, not quotable

No summary for this filing – the full text is below.

Full announcement

Select text to share a quote on X · sign in to keep highlights & notes in your IBAI notes

Total Voting Rights

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.

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

Cleaned text: letterheads, contacts and legal notices removed. View the original announcement ↗ · Company filings. Not investment advice.

Share this quote

Quote card
Post on X WhatsApp Download image

The link opens this announcement with the quote highlighted. Quotes are checked against the original text.

Add a note