IQ-AI LIMITED ISSUES LETTER TO
SHAREHOLDERS
IQ-AI
Limited ("IQAI") (LSE: IQAI) a
developer and manufacturer of medical image processing platforms
and therapies for cancer, has today released a letter to
shareholders on behalf of Michael Schmainda, CEO of IQ-AI's wholly
owned subsidiary Imaging Biometrics (the "Company").
The
full text of Mr Schmainda's letter follows:
"Dear
Shareholders,
Thus
far, 2024 has been marked with new levels of revenue, milestones in
product development, and business advancement. Operationally, we
maintain a lean and efficient team while balancing a diverse array
of products and projects, each of which we believe possess
significant business potential.
Instead
of providing a traditional update in letter format, we have decided
to address some of the specific questions we have received, and
anticipate receiving, regarding these key initiatives in a Q&A
format. No doubt we will not address everyone's specific question
here, but please be assured we are committed to providing updates
on all material matters as soon as they are made
available.
Q:
Where
are we with the phase 1 clinical trial?
A:
The end of our sponsored phase 1 trial is imminent. Two more
patients are needed to complete the expansion phase at the final
dose level. Once enrolled, they need to remain in treatment for
four weeks for the data to be included in the summary analysis.
Enrolling these last few patients has taken longer than anticipated
and, while many patients have been screened, they have not met the
eligibility requirements. Our experience has shown; however, this
can change in an instant and we could receive an influx of eligible
patients at any time.
Internally,
our focus has shifted towards phase 2 planning and preparation.
This includes scheduling an "End of Phase 1" meeting with the FDA.
These meetings, formally referred to as "Type B" meetings, require
documentation to be prepared and submitted to the FDA well in
advance of the meeting. Since scheduling these meetings can take
several months, we are working on the documentation now with the
aim of securing a meeting later this quarter.
Once
the phase 1 trial is fully enrolled, the Medical College of
Wisconsin (MCW) is planning to become an active site for our
Expanded Access Program (EAP). This
will allow patients who cannot participate in the Phase 1 trial to
access GaM through the EAP.
Q:
The
Expanded Access Program (EAP) opened several months ago. How has it
been progressing?
The
ramp up of the EAP has taken longer than we anticipated. This is
due to the individual sites' local Internal Review Board (IRB)
approval processes. Obtaining approvals and navigating various
administrative policies was frustrating for both us and the
patients who want to participate. At the time of this writing, we
have three activated sites (NY, NC, and CA) and two patients
receiving oral GaM. Several sites are at various stages of the
activation process and are moving closer to activation.
Q:
What
is IQAI's plans for a phase 2 trial?
As
part of the phase 1 sponsorship agreement, IQAI owns the rights to
the phase 1 results and data, including the right to pursue FDA
approval and commercialization. As such, we are keenly interested
in maintaining our involvement in the development of IB-003 via a
phase 2 trial. The agent has met phase 1 objectives. It has
demonstrated an excellent safety profile, proven to be well
tolerated in humans with no dose limiting toxicities, and has
demonstrated preliminary signals of efficacy. These results are
encouraging.
Phase
2 trials are designed with an appropriate number of subjects to
statistically prove efficacy. The planned phase 2 trial will be
multi-site with a target enrollment of 60 subjects. More details
need to be finalized including the amount of funding required, but
various sources of funding are being explored now including grants,
foundational support, and revenue generated from sales of
products.
Q:
What
are the benefits of obtaining Rare Pediatric Disease Designation
(RPDD) with the FDA when the Voucher Program has a termination date
of Sept 30, 2026?
All
the regulatory milestones achieved over the past 18 months were
strategically pursued using authorized FDA pathways. No funding was
required to apply for these designations, and each offers unique
benefits and incentives for pursuing commercialization. With
respect to RPDD, two recent pieces of legislation have been
introduced that, if passed, will extend the termination date for
the voucher program. See below:
On
4th October 2024
U.S.
President Biden signed a bill postponing the termination
date
of the rare pediatric disease Priority Review Voucher (PRV) program
from September 30, 2024, to December 20, 2024. The bill, the
"Continuing Appropriations and Extensions Act, 2025" is a temporary
measure to continue the rare pediatric disease PRV program. There
are currently other ongoing legislative efforts to renew the
program to
2028
and later. We have summarized these proposals
below.
U.S.
President Joe Biden has signed into law H.R.
9747, the
"Continuing Appropriations and Extensions Act, 2025," postponing
the expiration
date of
the rare pediatric disease PRV program. The date by which a drug
must be designated as a drug for a rare pediatric disease was
changed from September 30, 2024, to December 20, 2024. The date by
which such designated drug must be approved in order to receive a
PRV remains September 30, 2026. This change is reflected
on FDA's
webpage for
the rare pediatric disease program, although the agency has noted
that it may not be able to meet all review timelines if there is a
surge in requests prior to the deadline. There are two primary
legislative proposals that may renew the program either
to
2028
or to
2029.
H.R.3433, the
"Give Kids a Chance Act of 2024," was passed by the House of
Representatives and is under consideration in the Senate's
Committee on Health, Education, Labor, and Pensions (HELP). It
would reauthorize the rare pediatric disease PRV program such that
FDA may award PRVs through September 30, 2029, give FDA new
authority to enforce requirements that drug sponsors conduct
pediatric studies, and incentivize drug makers to conduct pediatric
clinical trials when studying combinations of multiple cancer
drugs. The bill also adds a requirement for the Government
Accountability Office (GAO) to conduct a report on the impact of
PRVs, including examining whether the vouchers are successful in
promoting development of new rare disease drugs and in expediting
patient access.
The
"Give Kids a Chance Act" also includes provisions from the
"Retaining Access and Restoring
Exclusivity" (RARE)
Act, as
it would specify that the seven-year market exclusivity period for
drugs for rare diseases or conditions (i.e., orphan drug
exclusivity) prohibits the approval of the same drug for the same
approved use or indication with respect to the disease or
condition, codifying in statute FDA's long-standing interpretation
of the Orphan Drug Act that was called into question in a 2021
case, Catalyst Pharms, Inc. v. Becerra.
Meanwhile, H.R.
7384, the
"Creating Hope Reauthorization Act" would amend the date by which
the drug must be designated as a rare pediatric disease drug to
September 30, 2028 and the date by which the application must be
approved to September 30, 2030. This bill was introduced in the
House and referred to the Energy and Commerce Committee's
Subcommittee on Health.
If
the rare pediatric disease PRV program is not reauthorized,
eligibility to receive a voucher will be limited to products that
receive rare pediatric disease designation by December 20, 2024,
and are approved by September 30, 2026.
Q:
Why
did IQAI create a promotional video of IB Nimble?
Promotional
videos are an efficient and recyclable way to showcase the
tremendous work and accomplishments of our development team. The
video includes some features that we believe will further position
IB Nimble as a needed and valuable mobile device for managing
complex diseases securely and timely. Dr. Bovi, who had the
original vision for IB Nimble, praised the video and is sharing it
with his colleagues as an invitation for a deeper conversation and
an initial meeting with that site.
Q:
Is
the Company pursuing regulatory clearance for
IB
Zero
G?
We
remain excited about the prospects of the patented technology
within IB Zero G and the disruptive shift it represents to current
clinical paradigms. We have continued the refinement of the
artificial intelligence ("AI") model as well as our collaborative
relationship with a major children's hospital.
Currently,
we are focusing on product development initiatives that will
deliver sales in the near term with our current portfolio of FDA
cleared products. Once those are completed, we will allocate
resources and revisit an FDA submission. This will likely result in
a modified indication for smaller populations such as children,
pregnant women, patients with compromised renal function, and other
patients who would appreciate a "gad-free" alternative when
receiving repeated MR exams. This is challenging, however, because
there is no predicate device on the market to which substantial
equivalence can be demonstrated.
Q: It
was recently reported that sites are interested in fractional tumor
burden ("FTB") maps, but few sites have adopted the technology.
Why?
At
the recent American Society of Functional Neuroradiology (ASFNR)
meeting, a survey question was polled, and the results were very
encouraging to us. The respondents to the question, "Has your site
adopted FTB maps for DSC analysis?", indicated 92% are interested
and, of those, ~70% have not yet adopted our FTB mapping approach -
despite a growing body of scientific backing and clinical
validation that prove the many benefits.
We
believe we are overcoming the last major hurdle to clinical
adoption: automation. We
know hospitals are under tremendous cost and productivity
pressures. We also know burnout and turnover rates are real issues
facing radiology departments in general. Our fully automated FTB
processing pipeline eliminates the remaining manual, time-consuming
step. It will be released with the next version of IB Clinic as
soon as the documentation is complete.
Q:
What
is the current status of the Company's resubmission of the CPT code
application?
Last
year, we applied for the assignment of a specific CPT code for our
core processing application using IB Neuro. As we reported, the
feedback from the editorial panel offered valuable insights and
recommendations for a resubmission. We also communicated that many
sites are using an existing CPT code now to obtain medical
reimbursement for this specific procedure. This is not universally
accepted, however, as it appears some sites do not pursue this
approach. Regardless, we continue to share this information with
all our clients and are discussing a resubmission
strategy.
Q:
What
can we expect in 2025?
Early
in 2025 we will obtain summary results of the phase 1 trial. Those
results, and the Real-World Data ("RWD") that will be accumulated
via the EAP, will give great insights into our commercialization
pathways. As we communicated, RWD is significant because it
represents the general population and, therefore, may be more
informative than tightly controlled clinical trial data.
We
thank you for your continued support and look forward to sharing
more updates.
Sincerely
yours,
Michael
Schmainda,
CEO
Imaging Biometrics, LLC
Director
IQ-AI Ltd"
The
Directors of the Company accept responsibility for the contents of
this announcement.
-ENDS-
For
further information, please contact:
IQ-AI
Limited
Trevor
Brown/Brett Skelly/Vinod Kaushal
Tel:
020 7469 0930
About
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 IB, visit
the company's website at
www.imagingbiometrics.com.