IQ-AI Limited - IB Letter to Shareholders

Imaging Biometrics

13/10/2023 08:55

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RNS Number : 0709Q  IQ-AI Limited  13 October 2023

IQ-AI Limited

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

 

Imaging Biometrics LLC Letter to shareholders

IQ-AI Limited ("IQAI") (LSE: IQAI) a developer and manufacturer of medical
image processing platforms, has today released a letter to shareholders on
behalf of Michael Schmainda, CEO of IQ-AI's wholly owned subsidiary Imaging
Biometrics (the "Company"), covering several material recent developments in
the Company, including, inter-alia,

·      Regulatory milestones achieved for oral Gallium Maltolate

·      IB Clinic™ & IB Nimble™ deployments

·      New applications for IB Neuro

The full text of Mr Schmainda's letter follows:

Dear Shareholders,

I am pleased to share this update with you. It summarises our progress made
and outlines some major milestones to be achieved.

Earlier this year, we made the strategic decision to apply for a Current
Procedure Terminology (CPT) code specific to the DSC perfusion technology
available in IB Neuro. CPT codes are assigned and maintained by the American
Medical Association (AMA). They are used to track and bill medical services
for payer reimbursement. Like regulatory clearance, CPT codes are a critical
aspect in achieving widespread commercial adoption in healthcare. Currently, a
few of our clients are using a general, non-specific CPT code to get
reimbursed for the MRI procedures that rely on IB Neuro, but only a limited
few. This lack of a reimbursement pathway makes it more difficult for hospital
administrators to justify investing in IB products. Fortunately, enough
scientific and clinical validation have been performed by our co-founder,
Kathleen Schmainda, PhD and her colleagues over the years, and a growing
number of sites are routinely using IB Neuro as the standard of care, to
warrant a dedicated CPT code. The application is due in early November and a
final decision will be made in May 2024. A CPT code will help make for easier
buying decisions for healthcare administrators.

IB Clinic Deployment

Steady progress is being made in the deployment of IB Clinic; both in terms of
direct sales and through our established partnerships. We are encouraging our
long-standing clients to migrate from our legacy, manual, and Mac-based
platform, and upgrade to our platform-independent and automated IB Clinic
application. This upgrade is being well received as it addresses the many
challenges facing busy radiology departments around the world. For example, it
consolidates needed information on a single dedicated workstation and creates
a one-stop-shop for busy radiologists, it reduces the number of workstations
requiring support from IT personnel, and it offloads MR Technologists who no
longer have to manually process the information.

These gains in clinical efficiency dovetail perfectly with our strategy of
making IB products accessible on larger, more comprehensive platforms, such as
those offered by GE Healthare, Bayer, TeraRecon, and our other partners.
Currently, we are working very closely with each of them in preparation for a
busy tradeshow season. And, as you can imagine, all our partners share in our
excitement of potentially receiving a CPT code for IB Neuro.

IB Nimble

Our development team has made tremendous enhancements to our handheld / mobile
application, IB Nimble. Specifically, the code base is being re-engineered to
enable widespread distribution and efficient support. More work remains, but
interest is steadily growing from other brain (mets) cancer centers. As
promised, we also deployed IB Nimble for use in a new disease group,
metastatic bone cancer, at the Medical College of Wisconsin (MCW). We
anticipate at least one more installation in Q4 2023.

Also, we just accepted an invitation to participate in a new initiative
launched by the American Brain Tumor Association (ABTS) called the Metastatic
Brain Tumor Collaborative. Among other benefits, this is an ideal opportunity
to present IB Nimble and IB Clinic to broad audiences throughout 2024.

IB Neuro

Our flagship product, IB Neuro, continues to be used to advance the field of
neuro imaging with ground-breaking research. Recently, a major multi-center
study was published in Nature Communications, a prestigious scientific journal
with a high impact-factor, in which IB Neuro was used to identify infiltrating
cancer in the margins of tumors. Using IB Neuro, the team of researchers found
that the invasive tumor margins contain biologically distinct genetic and
molecular alterations. This information gives insights regarding tumor
aggressiveness and disease recurrence, and it also provides information that
can optimise treatments that could improve future outcomes. Essentially, the
information could potentially direct which treatments will be most effective
on a personalised basis.

At the recent American Society for Functional Neuro Radiology (ASFNR), Dr.
Jerry Boxerman, MD presented preliminary results from a study that used a
specific output of IB Neuro called percent signal recovery (PSR). The study
showed promise in distinguishing tumor types which is significant because it
demonstrates a noninvasive way to obtain critical information that is
currently obtained via invasive surgical procedures.

Finally, funding from current NIH grants continues and new funding
opportunities are being explored. It is through these grant collaborations
with top academic centers that result in the translation of ground-breaking
treatments into routine clinical care. We have identified a large new grant
opportunity that is specific to our core imaging technologies, and we are
evaluating potential aims for a February submission.

Clinical Trial Update

Our sponsored phase 1 clinical trial of oral gallium maltolate (GaM) has
increased momentum since it opened in March of 2022. Patients enrolled and
were prescribed escalating doses of the agent per the trial's design with the
primary goal of identifying the maximum tolerated dose (MTD) for a phase 2
trial. Because patients have tolerated the agent so well, an amendment to the
trial's IND had to be written and has since been approved to allow subjects to
be administered higher dose levels. This is because the patients have
tolerated the initial doses of the agent extremely well and a phase 2 trial
requires that a MTD be determined. This dose escalation corresponds to an
increase of subjects from 24 to 36. As soon as the MTD is determined,
enrollment for the phase 1 trial will halt, data will be summarised, and focus
will shift for the commencement of the phase 2 trial.

In addition, the FDA recently granted orphan drug designation (ODD) status for
GaM in the treatment of another rare cancer, atypical teratoid rhabdoid tumor
(ATRT), which was based on yet another pre-clinical study conducted in the
Schmainda lab at MCW. This is the second ODD for GaM this year. We are
currently working on an application for FDA Fast Track Designation. This is a
program the FDA uses to fosters accelerated development and review of drugs
that treat conditions with an unmet clinical need. We are targeting a
submission by the end of October.

Once that submission is under review, and to leverage our ODD designation for
pediatric brain tumors (GBM and ATRT), we will apply for a Rare Pediatric
Disease Priority Review Voucher (RPD-PRV). Like the Fast Track program,
RPD-PRV is another accelerated pathway authorised by the FDA which offers
incentives for development and approval for promising drugs. If IB is
successful in applying for an RPD-PRV, the vouchers can be transferred (sold)
to other companies and the trading price of a PRV, per KIDS V CANCER
(givekidsachanceact.org) (https://www.givekidsachanceact.org/) , is averaging
$100 million.

Finally, since the trial's launch, Dr. Jennifer Connelly, MD, the principal
investigator of the trial, has escalated the trial's exposure to a global
level through her many lectures and speaking invitations. Recently, she was
invited to speak at the Society of Neuro Oncology (SNO) Africa meeting in
early November.

Our optimism remains high for the multiple initiatives we are pursuing, and we
look forward to sharing additional information as more progress and milestones
are achieved.

 

Sincerely yours,

Michael Schmainda,

CEO

Imaging Biometrics, LLC

Director IQ-AI Ltd

 

 

--ENDS-

 

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

 

For further information, please contact:

IQ-AI Ltd

Trevor Brown/Vinod Kaushal/Brett Skelly/Michael Schmainda

Tel: 020 7469 0930

Peterhouse Capital (Financial Advisor and Broker)

Lucy Williams / Heena Karani

Tel: 020 7220 9797

 

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.

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