Radiopharm Theranostics

RICCARDO CANEVARI

CEO & MANAGING DIRECTOR

(ASX:RAD)

◾ Company Name: Radiopharm Theranostics ◾ Company ASX code: RAD ◾ Key areas: Biotechnology / cancer radiotherapy ◾ Key Personnel: Riccardo Canevari, CEO & Managing Director | Paul Hopper, Chairman Professor | David Mozley Chief Medical Officer ◾ Locations: Australia, United States, European Union ◾ Market Cap as of 15/09/22: $42.14M ◾ 52 Week share price as of 15 September: $0.130 - $0.495 ◾ Company Website: radiopharmtheranostics.com

COMPANY PROFILE

Radiopharm aims to become a leader in the innovation and development of both diagnostic and therapeutic radiopharmaceuticals products for use in areas of high unmet medical needs, like oncological diseases – commonly known as cancer.

Radiopharmaceuticals are safe radioactive drugs that can be used as diagnostic or therapeutic tools.

In diagnostics, patients are given a very small amount of safe radioactive medication injected into the bloodstream.

Then low energy radioisotopes are used to allow physicians to see and measure disease within the body, via imaging.

In therapeutics, high energy radioisotopes are used to treat malignant tumours. This involves attaching a radioisotope to a targeting agent such as a small molecule or antibody which delivers a radioactive payload to tumour cells.

Recently the company signed an exclusive sublicensing agreement with NeoIndicate for the rights to develop the PTPμ-targeted radiopharmaceutical agent as an imaging diagnostic and as a targeted radiopharmaceutical theranostic as part of its clinical development pipeline.

When combined with low level radiation, the agent functions as a highly specific Positron Emission Tomography (PET) imaging agent - and when combined with high energy radiation, the agent works as a radiopharmaceutical theranostic to destroy tumours.

Basically, the PTPμ-targeted agent labels invading tumour cells far away from the main tumour mass, achieving specific recognition of the full extent of an invasive tumour. It also recognizes this fragment in multiple tumour types including brain tumours and gynaecological cancers.

The technology has shown encouraging pre-clinical data in human glioblastoma (GBM) tumour models, which have limited treatment options and poor prognosis, and represent an immediate, unmet need for targeted therapies with high sensitivity and specificity.

That’s where Radiopharm comes in, with plans for the manufacturing of PTPμ to kick off in December 2022. The company has also worked to secure isotopes for the purpose of conducting clinical research, development, manufacture and earlystage commercialization of the company’s diagnostic and therapeutic products.

In June, they reached an agreement with Isotopia Molecular Imaging for the supply of high-quality Lutetium-177 N.C.A – which has shown significant promise in treating a variety of late-stage cancers.

The company has also established relationships with some of the world’s foremost cancer research organisations and suppliers, including a licensing agreement with the University of California Los Angeles Technology Development Group (UCLA-TDG) for its promising LRRC15 antibody DUNP19.

Currently available antibodies for cancer treatment omit tumour micro-environment (TME) cells, such as stromal and immune cells, which comprise >50% of tumour masses.

The DUNP19 antibody has a unique ability to effectively find, internalize and destroy both cancer and TME cells – and the agreement gives Radiopharm the rights to develop DUNP19 as an Antibody-Drug Conjugates (ADC) within radiotherapy as part of its clinical development pipeline.

Meanwhile in Australia, Radiopharm has extended its agreement with global oncology provider GenesisCare who will support a second clinical trial using the company’s PSA targeting antibody to start a therapeutic Phase 1 in prostate cancer, with an expected commencement in the coming months.

Notably, the antibody can target free human prostate kallikrein (PSA) in prostate cancer cells, enabling radioimmunotherapy and diagnosis of advanced prostate cancer.

The company says this innovative approach and novel mode of action compared with other treatments under development make its technology highly prospective.

KEY INVESTMENT HIGHLIGHTS

FEBRUARY 1, 2022: Signed a deal with TerraPower, a leading nuclear innovation company, to advance the next generation of radiopharmaceutical therapies for cancer treatment. MARCH 23, 2022: Agreed on a Letter of Intent (LOI) with GenesisCare to start its first Phase 1 trial in Australia targeting the PDL1 expression in non-small cell lung cancer. JULY 21, 2022: Extends agreement with global oncology provider GenesisCare, who will support a second Radiopharm clinical trial for prostate cancer in Australia.