IQ-AI Regulatory News (IQAI)

June 14, 2024

IQ-AI Ltd

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

IQ-AI Reports Phase 1 Update and Shares Plans for Phase 2 Clinical Trial

As the end of the Phase 1 clinical trial draws closer, IQ-AI Ltd (LSE: IQAI) shares the latest Phase 1 updates and outlines plans for continued development of the oncology-focused drug, oral gallium maltolate ("GaM").

Brief Background & Progress to Date

In April 2021, after reviewing the pre-clinical research completed by Dr. Christopher Chitambar, MD, Emeritus Professor of Medicine and Biophysics, Division of Hematology and Oncology and Dr. Kathleen Schmainda, PhD, Professor of Biophysics, both at the Medical College of Wisconsin ("MCW"), the directors of IQAI made the decision to finance a Phase 1 clinical trial at the MCW Cancer Center ("MCWCC"). This commitment enabled the trial to commence after obtaining authorization to proceed from the FDA and, in March 2022, the trial was officially opened for enrollment of adult patients with relapsed or refractory glioblastoma.

The successful execution of the trial is primarily due to the efforts of the clinical team, led by Dr. Jennifer Connelly, MD (Neuro-Oncology), and Dr. Christopher Chitambar, MD (Hematology and Medical Oncology). Interest in the trial has grown considerably in the past two years, as evidenced by the growing number of presentations and lectures requested globally from Dr. Connelly.

The clinical Phase 1 study is designed to treat groups of patients with relapsed glioblastoma brain tumors with different doses of oral GaM for a minimum of 2 months to evaluate drug toxicity and patient's tolerance to treatment and to establish a recommended dose for a Phase 2 clinical trial. Patients are allowed to continue treatment for longer than 2 months if treatment is tolerated without limiting side-effects and there is no progression of disease. In a cancer where, historically, patients experience progression of disease within 1 - 6 months following relapse, the Investigators found that some patients remained on treatment without disease progression for greater than 6 months; one patient experienced no progression of disease for longer than one year. All patients treated with GaM have tolerated the drug well and have not experienced dose-limiting adverse side-effects. Based on the current rate of patient enrollment to the study, the trial is expected to conclude this fall. The results of this Phase 1 study are in the process of being compiled and are expected to be reported in a publication by spring 2025.

While the results of the present study are encouraging, the directors of IQAI are acutely aware that the efficacy of GaM in glioblastoma can only be established in a well-designed Phase 2 clinical trial with an appropriate number of patients.

IQAI has exclusive rights to the results and data of the phase 1 trial for worldwide commercialization. This incorporates regulatory milestones from the FDA including FDA Fast Track designation, two orphan drug designations ("ODD"), and two rare pediatric disease ("RPD") designations.

Phase 2 Trial

The clinical team has already begun defining the phase 2 protocol. It will be a multi-center trial, estimated to span approximately three years, with a target enrolment of 50-60 patients. Overall survival ("OS") will be the endpoint. Our ongoing access to the FDA under Fast Track designation will help identify intermediate endpoints which may compress the timeline and expedite the approval process. End-of-phase 1 / 2 meetings with the FDA are critical in the development process, and we anticipate scheduling our end-of-phase 1 meeting when the phase 1 data analysis nears completion.

Firm costs are currently being determined but are projected between $2 - $2.5 million over the duration of the trial which is expected to commence in 2025. IQAI anticipates making a significant contribution to the costs of the Phase 2 trial, in combination with possible grants and further support from charitable foundations if necessary. We had previously expected to seek a partner for this stage of development but now believe that it would better commercially to continue in a proprietorial role during phase 2.

Intellectual Property

Intellectual Property ("IP") encompasses a diverse array of forms, such as data, dosing schema, biomarkers or diagnostic parameters, various methods of delivery, etc. We are acutely aware of the value IP has and are exploring potential mechanisms to strengthen our position. In our possession today are exclusive rights to phase 1 trial data and imminently the EAP data. Post approval, we will take full advantage of the seven years' market exclusivity offered by Orphan Drug Designation, which allows sponsors to sell the drug without competition. We intend to invest to strengthen IP during the seven-year market exclusive period including formulation improvements, delivery alternatives, and combination treatments.

Real World Data ("RWD") obtained in our Expanded Access Program ("EAP") can significantly enhance the generalizability of studies by providing insights into how diverse patient groups may respond to treatments in real-world settings. If RWD suggests certain groups will respond more effectively to treatment, a potential biomarker could be identified in those groups which would be a further form of IP. The RWD could be leveraged to guide future study designs, support regulatory submissions, reduce post-market surveillance studies, and more.

Partnership Potential

Significant progress has already been made using our own financial resources since first committing to sponsor this trial three years ago. Following the anticipated successful conclusion of the Phase 1 trial we intend to continue with direct financial involvement in the Phase 2 trial. Assuming a successful Phase 2 trial, the prospects, and opportunities for partnership with a larger partner will be significantly enhanced but there is also a possibility that negotiations could commence during the trial.

Research and Development

The iron-mimetic characteristics of GaM, which enable the anti-tumor activity, apply to all solid tumors. Other research projects are being planned that expand beyond adult brain tumors. As these efforts ramp up, new investment opportunities will arise. While we intend to focus on the current development path of GaM, we are keeping informed of those early pre-clinical projects and potential new clinical trials. Pediatric cancers for which we have Rare Pediatric Disease ("RPD") designations are of particular interest.

"The preliminary data from the clinical study is highly encouraging and has motivated us to continue the development in subsequent studies," said Trevor Brown, CEO of IQ-AI.

--ENDS-

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

For further information, please contact:

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.