IONIQ Science 2022 year-end update

December 20, 2022

For IONIQ Sciences, 2022 was another big year.

As we respond to the FDA’s substantive review of our De Novo application for the ‘breakthrough‘ IONIQ ProLung Test, powerful macroeconomic factors are highlighting the importance of early cancer detection. Despite uncertain conditions in the financial market, we have a compelling message for potential institutional and strategic investors at the right time.

Science and Clinical Evidence

• Thanks to your help and our trial sites, we’ve grown our clinical evidence library for lung, breast and GI cancer plus healthy volunteers by 40% in 2022. 
• We’re still scanning healthy volunteers and those with cancer especially from different racial and ethnic identities to represent our broadly diverse USA population. Get the details on Facebook, Linkedin or email us for details. 
• In early-2022, Dr. Rex Yung (IONIQ Chief Medical Officer), Natasha Andreasen (IONIQ Clinical Coordinator) and Dr. Amit Goyal (physician investigator from Loyola Univ Med Ctr) presented our latest lung cancer clinical trial results at the American Thoracic Society (ATS) medical meeting. 

Regulatory

• In Feb 2022, the IONIQ team – alongside a supporting cast of experts, consultants and partners – submitted the De Novo application for our ‘breakthrough‘ lung cancer system to the FDA. 
• Our team and consultants are currently working through the FDA’s substantive review of our De Novo application. We will share an update at the conclusion of the FDA review process. 

Product Pipeline – first lung, then breast and ultimately Multi-Cancer

• After publishing our breast feasibility trial results in IEEE in late 2021, we transitioned into a follow-on breast feasibility trial.  
• In Jun 2022, we unveiled our new LUNA 3 next-generation system designed to accelerate the transition of cancer testing from the hospital and doctor’s office into pharmacies and ultimately into consumers’ homes. LUNA 3 is already a “2022 Utah Innovation Award” winner! 
• We acquired additional intellectual property (IP) and technology that should accelerate our next-gen product development efforts (LUNA 3). 
• In a separate acquisition, we acquired IP formerly licensed to IONIQ, which means we own (rather than license) all of the IP used for our cancer detection platform. 
• We ultimately grew our Intellectual Portfolio to 22 issued and filed patents from just 11 last year. These are important and valuable corporate assets. 

Market attractiveness

• In early 2022, we successfully addressed the terms of our outstanding convertible notes and the vast majority of our warrants were either exercised or expired. All of this increases our market attractiveness to potential institutional and strategic partners. 
• In early 2022, we partnered with Edison Group as our Investor Relations Advisor. This relationship has already proven beneficial. 
• During 2022, we were recognized and awarded seven times for our achievements in modernizing early stage cancer detection. It’s inspiring! 

Macroeconomic factors

• Awareness of the importance of early cancer detection is arguably at an all-time high. Patient advocacy groups and the life science industry have captured the attention of governments and rule makers. IONIQ has a front row seat. 
  • The White House reignited its “Cancer Moonshot” and created a Cancer Cabinet to reduce the cancer death rate by half within the next 25 years. 
  • The Advanced Research Projects Agency for Health (ARPA-H) was also created and Congress funded it to partner with industry in large part to drive cancer research. 
  • Congress continues to evaluate how to legislatively ensure Americans will have access to existing and future multi-cancer screening solutions through Medicare. 
  • IONIQ joined Cancer Early Detection Alliance (CEDA), which is a nationally well-known patient advocacy group and is aligned perfectly with our mission to modernize early-stage cancer detection. 

Links to all of our corporate social media accounts, including our new Instagram account, can be found at the bottom of this email (@IONIQsciences).