Imagion Biosystems

ROBERT PROULX

PRESIDENT & CEO

(ASX:IBX)

◾ Company Name: Imagion Biosystems ◾ Company ASX code: IBX ◾ Key areas: Early cancer detection - molecular imaging technology using bio-safe magnetic nanoparticles to non-invasively find tumors ◾ Key Personnel: Robert Proulx, President & CEO ◾ Locations: Australia and United States ◾ Market Cap as of 15/09/22: $39.24M ◾ 52 Week share price as of 15 September: $0.026 - $0.105 ◾ Company Website: imagionbiosystems.com

COMPANY PROFILE

Imagion Biosystems is developing new medical imaging techniques using its ground-breaking MagSense® magnetic nanoparticle technology, with an aim to provide a non-invasive, more accurate means of identifying the presence of various types of cancer.

The molecular imaging technology helps patients avoid radiation exposure used in alternative imaging methods, as well as reduce the need for invasive and risky biopsy procedures.

It’s a combination of biotechnology and nanotechnology, using magnetic nanoparticles coated with a targeting molecule to detect cancer tumours.

Patients are given a low dose injection of the nanoparticle imaging agent, and the targeting molecule affixed to the nanoparticles finds and binds to tumor cells.

Once attached, the magnetic property of the particles acts as a magnetic beacon and is detectable by magnetic imaging technologies.

The tiny nanoparticles don’t stay in the body either, they’re cleared through the liver with the iron “repurposed” to produce ferritin which is used in hemoglobin production.

And the tech has been designated as a ‘breakthrough device’ by the US Food and Drug Administration (FDA) – which is only granted to novel medical devices that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

The MagSense® HER2 Breast Cancer imaging agent is already being evaluated in a clinical study investigating the potential for it to be used for nodal staging of HER2-positive breast cancer (where the patient tests positive for a protein called human epidermal growth factor receptor 2) by detecting if tumor cells have metastasized to the lymph nodes.

In 2022 alone, there are estimated to be around 287,000 new breast cancer cases in the US alone, with approximately 20% or around 57,000 being HER2 with metastatic spread to the lymph nodes.

Currently, nodal staging requires a patient’s lymph nodes to be surgically biopsied for histopathological examination, a process that hasn’t changed much in the last 50 years, whereas the MagSense® imaging agent can reduce the need for biopsies.

In fact, Imagion says its tech is expected to eliminate a whopping 48% of unnecessary biopsies for patients that do not have metastatic spread to the lymph nodes, reducing the incidence of lymphedema and associated morbidity.

Looking at cancer more broadly, making imaging more specific and less invasive is a huge market opportunity for Imagion because the global cancer diagnostic market is estimated to be worth around US$100 billion – yep, billion, with a “B” – annually.

The disease is still the leading cause of mortality, but the company is confident its tech will have improved sensitivity than current diagnostic techniques, making it better for routine use in early detection, and early detection means better survival outcomes.

As an added bonus, the tech is cheaper than PET or CT scanning machines and doesn’t require the installation expense of a shielded room.

Imagion is also undertaking R&D to build a pipeline of imaging products for other types of cancer such as prostate, ovarian, and brain cancers, in partnership and collaboration with world-class global universities and hospitals.

But cancer diagnostics isn’t the only commercial opportunity for the company, as Imagion is confident that the possibilities abound for its magnetic nanoparticles, from an MRI contrast agent, to therapy, to drug delivery, and even a printer-ink revenue model.

BIOSYSTEMS

KEY INVESTMENT HIGHLIGHTS

AUGUST 17, 2021: Establishes Joint Development Agreement with Global Cancer Technology to develop nanocrystals for treating breast cancer. MARCH 17, 2022: Reports interim results from MagSenseTM HER2 Breast Cancer First-in-human Study indicating imaging agent is safe and well tolerated by patients. APRIL 14, 2022: Enters Sponsored Research Agreement with researchers at Massachusetts General Hospital focusing on nanoparticle use with MRI.