28 October 2021
(“IQ-AI” or the “Company”)
IQ-AI LIMITED ISSUES SHAREHOLDER LETTER
Company Enjoys Most Successful Year on Record
Marked Increase in Revenue and Growing Technology Portfolio
Sponsorship of a Phase I Clinical Trial
Milwaukee – 28 October 2021: IQ-AI Limited (OTCQB: IQAIF) (LSE: IQAI), a developer and manufacturer of medical image processing platforms, released a letter to shareholders from Director Michael Schmainda. The entire letter follows:
The intent of this inaugural quarterly letter is to share our optimism with our shareholders and to help underscore the tremendous progress and potential of our company.
2021 has already proven to be our busiest and most successful year on record. The marked increase in revenue, our growing technology portfolio, our advancement of new products and platforms, and our sponsorship of a Phase I clinical trial drive our strategy to build upon the momentum gained during this banner year. Our listing on the OTCQB: IQAIF, which provides direct access for U.S. investors, is another key milestone that positions us to achieve our goals as we head into 2022. Likewise, our Depository Trust Company (DTC) application, which is in process, will provide clearing and settlement efficiencies between custodian banks and broker-dealers. We are also accelerating product development with the expansion of our software team. A senior software engineer with artificial intelligence (AI) experience will join us as a fulltime employee on November 8th.
Year-to-date revenues have more than doubled, driven primarily by the continued adoption of IB Clinic – container edition (IB Clinic), and the continued funding from awarded grants from the National Institutes of Health (NIH). IB Clinic provides seamless integration of fully automated processing of our clinically validated software platforms. While ideally suited for large, high-volume brain cancer centers, IB Clinic can be easily adopted by hospitals and diagnostic imaging chains of any size. The growing market acceptance of our automated applications has intensified our focus on the continued development and enhancement of IB Clinic. Automation has the obvious benefit of off-loading busy radiologists and technologists, and the quantitative output provides healthcare systems with consistency that improves efficiency in study interpretation and longitudinal comparisons. We are proud to be the only company that can offer quantitative magnetic resonance (MR) imaging software that answers the most frequently asked question in neuro oncology today: “is the enhancing region tumor or is it treatment effect?”. Our pipeline is healthy, with two additional National Cancer Institute (NCI) designated cancer centers undergoing trial evaluations of IB Clinic.
Our flagship product, IB Neuro™, is at the heart of our automated and quantitative processing. This product was the outcome of a multi-year comparison study published in Radiology in 2008. In this landmark study, the technology developed by the co-founder of IQAI’s subsidiary, Imaging Biometrics, LLC (IB), Professor Kathleen Schmainda, PhD, at the Medical College of Wisconsin (MCW) demonstrated superiority over other technologies that proclaimed to do the same computational analysis. Specifically, the approach used by Professor Schmainda uniquely accounts for contrast agent leakage across the blood-brain-barrier (BBB) and was able to distinguish between tumor and normal brain tissue more reliably than the commonly available technologies to which it was compared. Since then, the underlying technology has been enhanced by Professor Schmainda and the team at IB, which has enhanced and further differentiated IB Neuro from the competition. More recently, it has been recognized to be consistent with the national consensus recommended protocol for MR DSC perfusion imaging, a protocol officially endorsed by several of the major neuro-oncology and neuro-radiology societies.
We are acutely aware other groups offer varied and inconsistent versions of DSC perfusion imaging platforms. These groups use their internal versions to conduct and publish studies that may not always shed a favorable light on the true diagnostic value of DSC imaging. In our early days, this resulted in confounding reviews and prolonged the sales cycle of IB Neuro. Fortunately, decades of proven science are on our side: We have the scientific track record and a growing body of published literature that backs up the quality, accuracy, and robustness of our products. We continue to invest in our core platforms, and we are grateful for Professor Schmainda and our long-standing collaborators who continue to translate novel technologies and ideas from the laboratories to routine clinical use.
New products and technology development are also at an all-time high for us. In June of this year, we were awarded a US patent for IB Zero G™, our 0% gadolinium AI technology: this technology uses only non-contrast medical images as input and generates synthetic “with-contrast” images as output. Since receiving the patent, and as announced in recent press releases, we have attained and labeled over 1,000 datasets for development purposes, we have completed the processing pipeline, and will prepare a US FDA 510(k) application for a late Q1 2022 submission. We believe the disruptive potential of IB Zero G to be extremely exciting on multiple levels: institutional costs of gadolinium-based contrast agents (GBCAs) are significant and could be avoided, administering GBCAs is an additional step in the clinical workflow, and GBCA administration can be prone to error if not done properly. From the patient’s perspective, GBCAs are administered intravenously. Therefore, patients could enjoy a more comfortable scan experience if GBCA administration is avoided. And, while still unknown, the long-term adverse side effects of repeated GBCA dose administrations remain a concern. IB Zero G addresses these concerns, from both a patient risk and an institutional liability standpoint.
The market drivers for IB Zero G are as follows:
· People with compromised renal (kidney) function cannot efficiently process contrast agents and are at risk of nephrogenic systemic fibrosis (NSF), which is an untreatable condition that gadolinium contrast can cause. Kidney patients, mostly those in late-stage renal disease, have the highest risk. This means there is a population of patients who would immediately benefit from this technology.
· If hospitals can minimize these concerns without compromising image quality, it will be an easy decision to adopt IB Zero G. GBCAs are expensive and administering them – via power injectors, intravenously – can inhibit patient throughput on capitally-intensive MR scanners. In some cases, GBCAs may not be administered properly, thus rendering the patient scan a waste and requiring the patient to be reschedule for a repeated scan.
· Pediatric and neonatal patients, as well as patients who require multiple MR contrast-enhanced scans, such as Multiple Sclerosis (MS) and follow-up brain tumor patients, stand to benefit as well since contrast-enhanced images provide critical diagnostic information not available with other standard imaging technology. Patients with understandable concerns about gadolinium retention in the body will find IB Zero G as an attractive alternative.
In addition to IB Zero G, we are focusing development efforts on IB Trax™ (metastatic tumor monitoring), IB “CAD” (AI to detect infiltrating tumor cells not visible on standard MRI), and “dual echo”, our patented MR acquisition and post-processing technology that generates both DSC and DCE (dynamic contrast enhanced) parameters using a single MR acquisition and a single dose of GBCA. IB Trax is being designed to facilitate an optimal workflow for systematically tracking metastatic brain lesions. At its core, IB Trax will employ IB Delta T1 (patent pending) maps to help identify and track the locations and sizes of metastatic tumors. Metastatic brain lesions are much more prevalent than primary tumors, and the industry is lacking a robust and reliable platform that reduces errors and improves efficiency for follow-up imaging and volumetric analysis. We believe we have the core tools that can provide a competitive advantage and, more importantly, help clinicians help patients. IB CAD is another AI-based technology that has demonstrated the ability to detect infiltrating cancer cells that are not visible on standard imaging. We anticipate this having a tremendous influence on the future management of and treatment planning for brain tumors.
Our longstanding involvement in the brain tumor imaging sector, and our relationship with Professor Kathleen Schmainda, PhD, led to this year’s pinnacle announcement – the sponsorship of an oral agent that combats high-grade brain tumors. Imagine if a brain cancer patient could take a daily pill, experience no adverse side effects, and live much longer than they can using today’s standard of care. That is our goal and, given the highly promising results of pre-clinical studies, we intend to follow this through to the end. Prior Phase I clinical studies have shown that the key ingredient, gallium, was well tolerated in human subjects. As previously announced, we are working with the principal investigators of the study as we qualify a new vendor for encapsulating the agent. These things never go as fast as we like, but progress is being made.
On October 1st we enlisted an experienced US based client relations manager to help us market our software and sell it to prestigious health networks. We have an established footprint in a growing number of National Cancer Institute (NCI) designated cancer centers that purchase annual license subscriptions to IB Clinic. Give the large number of cases processed at these high-volume centers, these annual subscriptions consistently range well above $100,000 per year. We intend to focus our efforts on deploying IB software to more NCI-designated cancer centers in 2022 and, as mentioned previously, have active trials in two more sites.
We have not attended any medical or science conferences since the Covid-19 pandemic began, but we plan to be active participants once again at upcoming shows, including SNO (Society of Neuro Oncology), ASNR (American Society of Neuro Radiology), ASFNR (American Society of Functional Neuro Radiology) and RSNA (Radiological Society of North America). We continue to conduct R&D with our collaborators at MCW, Mayo AZ, Rhode Island/Brown University, the University of Southern California (USC), and the Barrow Neurological Institute (BNI).
I want to emphasize we are the only dynamic susceptibility contrast (DSC) MR perfusion platform that generates quantitative parameter maps and the only platform validated with actual tissue biopsy samples. Our software has been repeatedly proven to accurately distinguish between tumor and non-tumor tissue – a basic yet critical question challenging treatment teams each day. We are also the only company that can generate quantitative difference maps. The quantitative approach we use accounts for the inherent variability within MR scans and across vendors: even if a patient is scanned on the same day, on the same scanner, with all the same scanner settings, by the same technologists, the maps will appear different and are only qualitative. With our quantitative technology, clinicians can now directly (numerically) compare MR DSC perfusion output independent of scanner, patient, timepoint, etc. This direct comparison between scans allows clinicians and their patients to assess treatment response on a timelier and more consistent basis. Our software provides this information sooner and helps clinicians optimize treatment, extend lives, and improve quality of life of their patients.
In closing, I want to extend our sincere appreciation to all our shareholders. I look forward to providing you with more exciting news and continued progress in this quarter and as we ramp up for another milestone year in 2022.
Michael Schmainda, CEO
Imaging Biometrics, LLC
About Imaging Biometrics, LLC
Imaging Biometrics®, a subsidiary of IQ-AI Limited (LSE: IQAI)(OTCQB: IQAIF), develops and provides visualization and analytical solutions that enable clinicians to better diagnose and treat disease with greater confidence. Through close collaboration with top researchers and clinicians, sophisticated advancements are translated into platform-independent and automated software plug-ins which can extend the base functionality of workstations, imaging systems, PACS, or medical viewers. By design, IB’s advanced visualization software seamlessly integrates into routine workflows. For more information about Imaging Biometrics, visit the company’s website at www.imagingbiometrics.com.
Safe Harbor Statement
This press release includes statements that may constitute forward-looking statements made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” or the negative of these words and/or similar statements. Statements that are not historical facts, including statements about the Company’s beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. For example, statements about future revenues and the Company’s ability to fund its operations and contractual obligations are forward looking and subject to risks. Several important factors could cause actual results to differ materially from those contained in any forward-looking statement. Potential risks and uncertainties include, but are not limited to, the inability to raise capital to support the Company through its growth stage, the Company’s inability to generate projected sales and trade relations between the United States and China. The Company does not undertake any obligation to update any forward-looking statement, except as required under applicable law.
Investor Relations Contact:
Michael Porter, President
Porter, LeVay & Rose, Inc.