REG - IQ-AI Limited - Operations Update

IQ-AIAnnouncement

22/01/2025 07:00

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RNS Number : 1961U  IQ-AI Limited  22 January 2025

IQ-AI Ltd

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

 

Operations Update

 

IQ-AI is pleased to announce an operations update. In this update, we focus on
the relevance of artificial intelligence ("AI") to our business, describe
ongoing product development utilising AI in 2025, and provide an update on the
Phase One clinical trial.

 

Overall, radiology leads the way in FDA approvals for AI-enabled products as
the FDA has increased efforts to keep pace with the advancements in AI
technology. The directors believe IQ-AI, through its subsidiary, Imaging
Biometrics, LLC ("IB"), is in a unique position to lead this transformation
for neuro-oncology in 2025 and beyond.

 

IB CLINIC

The imminent release of the new version of IB Clinic; our FDA-cleared suite of
quantitative imaging solutions will include the incorporation of an AI model,
which will greatly improve diagnostic accuracy and speed. This AI model was
trained using brain tumor imaging data from both publicly available archives
and labeled de-identified data from the laboratory of Kathleen Schmainda, PhD
at the Medical College of Wisconsin ("MCW"); one of the largest data
repositories for both treated and untreated brain tumors in the world. The
workflow will leverage two machine-learning models to compute fractional tumor
burden ("FTB") maps. Used in combination, the models generate exclusive output
that applies to vascular tumors (including metastatic tumors) and spans the
entire spectrum of patient care. The resulting output are intuitive
classification maps of perfusion blood volume levels that reliably distinguish
normal from unhealthy tissue, often providing an indication of response sooner
than conventional imaging. As our recently appointed non-executive board
member, Dr. Al Musella, commented, "Every brain tumor patient and clinical
trial needs a FTB map". This new automated, AI-powered, FTB workflow makes
this possible.

IB ZERO G

IB Zero G leverages a variation of the AI model being implemented in the next
release of IB Clinic. Applicable functions of the model can be enabled by
simply toggling on/off certain sections of code to unlock the patented
technology. Our plan is to continue testing and refining the AI-generated
output of IB Zero G, prioritizing its readiness for FDA approval once other
key objectives are completed.

 

IB NIMBLE

The first half of 2025 should mark the next release of IB Nimble with the
functionality to view IB's AI-generated images and other images within the
mobile app. Thereafter, our attention will shift to the development of a
mobile app that allows patients to directly report their symptoms while
undergoing various treatment protocols. Their real-time feedback, both
structured and unstructured, will be archived in a global repository for
subsequent development using Large Language Models ("LLMs") and general AI
model development. We consider the use of this mineable data a significantly
untapped AI opportunity in healthcare; one that will lead to evidence-based,
personalized medicine for improved patient outcomes.

ASL

Also, in 2025 we anticipate releasing a new product leveraging arterial spin
labeling ("ASL"). As previously reported, ASL is a perfusion approach that
complements IB Neuro. Instead of using an injected contrast agent, ASL uses
the body's own blood. Clients have increasingly requested this technology from
IB. It has grown in clinical use particularly for measuring blood flow (as
opposed to blood volume) in the care of patients who suffered a stroke.

Finally, the development continues of a previously announced AI algorithm that
predicts where tumor cells will appear in the brain before they are visible on
standard imaging. This R&D effort, led by the Schmainda laboratory at MCW,
has the potential to disrupt surgical and radiation treatment planning, as
well as treatment surveillance, for cancer patients. Like IB Zero G, this
technology would require a new FDA 510(k) application and clearance, and it
will remain on our product roadmap given its continuing technological
advancement and its potential commercial impact.

Progress in the Phase 1 trial of Gallium Maltolate for Treatment of Relapsed
Glioblastoma

 

Glioblastoma ("GBM") is an extremely aggressive brain tumor. Despite standard
treatment with surgery, chemoradiation, and adjuvant chemotherapy, the median
survival of patients is only 14-16 months. The addition of electrical Tumor
Treating fields has extended the median survival by approximately 5 months.
Unfortunately, glioblastoma patients experience the recurrence of their
disease at which point progression-free survival ("PFS") is short. A recent
Cochrane Review reported the PFS following first recurrence of GBM is 1.5 to
4.2 months*. Hence, there is a dire need to develop new drugs to treat this
disease.

 

Based on positive results of our preclinical research, an FDA-approved Phase 1
trial of gallium maltolate ("GaM") for the treatment of patients with relapsed
glioblastoma was initiated. This trial is nearing completion. It is estimated
that the final patient (in the expansion phase) will be enrolled on the study
by the end of the first quarter or early in the second quarter of 2025 and
that a full report to the FDA will follow.

 

The Phase 1 clinical trial has two main objectives:

 

Safety and tolerance. The first objective is to determine the safety and
tolerance of glioblastoma patients treated with oral gallium maltolate and to
determine a Recommended Phase 2 Dose ("RP2D") of gallium maltolate for further
studies. This objective has been achieved. We have concluded that oral gallium
maltolate is extremely well-tolerated by patients and provides them with an
excellent quality of life during treatment. Based on measurements of gallium
in the blood and the manageable side-effects at the 2500 mg per day dose, we
will be recommending to the FDA that this amount be deemed the RP2D for
treatment of patients with glioblastoma.

 

Preliminary signals of response to treatment and future directions. The second
objective of the Phase 1 trial was to determine whether there were signals,
based on brain MRI, suggestive of a response to treatment. We are encouraged
to note that some patients treated with gallium maltolate have experienced a
longer progression-free interval when compared with historical controls. We
consider these signals to be encouraging in that it appears that some patients
have had the growth of their tumors retarded by gallium maltolate treatment.
Because a Phase 1 study is designed to only evaluate drug tolerance and
side-effects, no conclusions can be made regarding the true efficacy of
gallium maltolate in glioblastoma treatment.

 

Based on our encouraging preliminary signals of clinical response to GaM,
including the excellent quality of life experienced by patients, a Phase 2
clinical trial with enrollment of larger number of patients (for statistical
power) to determine the efficacy of the RP2D of gallium maltolate is
warranted.  A Phase 2 trial of gallium maltolate in glioblastoma treatment is
now in development.

--ENDS--

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

 For further information, please contact:

  IQ-AI Ltd

 Trevor Brown/Al Musella/Brett Skelly/Michael Schmainda

 Tel: 020 7469 0930
 Peterhouse Capital Limited (Financial Adviser and Broker)

 Tel: 020 7220 9797

About IQ-AI Limited and Imaging Biometrics, LLC

IQ-AI Limited, (LON: IQAI) (OTCQB: IQAIF), the parent company of
Wisconsin-based Imaging Biometrics, LLC (IB), is focused on delivering
quantitative imaging platforms and therapeutics that transform how clinicians
diagnose and treat patients more efficiently and effectively. For more
information about IQ-AI and Imaging Biometrics, visit the companies' websites
at iq-ai.ltd and imagingbiometrics.com (http://www.imagingbiometrics.com) .

 

*  McBain C, Lawrie TA, Rogozińska E, Kernohan A, Robinson T, Jefferies S.
Treatment options for progression or recurrence of glioblastoma: a network
meta-analysis. Cochrane Database Syst Rev. 2021 May 4;5(1):CD013579. doi:
10.1002/14651858.CD013579.pub2. PMID: 34559423; PMCID: PMC8121043.

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