IQ-AI Regulatory News (IQAI)

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.

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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.

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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.

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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.

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

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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.

* 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.