Company: Blinklab
Issue Price: $0.20
Funds to be raised: $7 million
ASX code: BB1
Lead Manager: Westar Capital (not underwritten)
Offer closes: 21 March 2024
Expected listing date: 4 April 2024
Market capitalisation on listing: $20 million
About Blinklab
Blinklab is currently developing its smartphone-based neurobehavioral diagnostic platform. The company plans to list on the ASX next month and will be the first IPO in the sector this year. The company's primary focus is on developing the tool for the testing and diagnosis of autism spectrum disorder (ASD).
The Public Offer consists of 35 million shares at an issue price of $0.20 per share to raise $7 million. Upon the completion of the IPO, the company's market capitalisation (undiluted) is approximated at $19.83 million (with the fully diluted market cap approximated at $27.58 million).
The $7 million to be raised (in addition to the $0.915 million in cash reserves) will mostly go to cover clinical studies and regulatory submission in the U.S. ($1.9 million), general operating expenses ($1.9 million), software improvement and tech support ($1.7 million), as well as R&D and business development ($1 million).
Blinklab cites its primary focus as completing clinical studies and obtaining regulatory approval to commercialise Blinklab in Europe and the U.S.
Blinklab's origins and IP
The origin of the technology was at the Department of Neuroscience at Erasmus University Medical Center in the Netherlands in the late 1990s, where researchers were working on 'eyeblink conditioning'.
In 2010 the technology was used in a mobile laboratory in a camper van. In 2017 the Blinklab co-founders, Dr Boele and the forthcoming CSO of Blinklab Dr Sebastian Koekkoek, set up an eyeblink conditioning lab at Princeton University where assessments were conducted on infants at risk of ASD.
The concept is that people with ASD will respond differently from people without ASD, not learning from previous visual stimuli when a subsequent visual stimulus is delivered.
In 2020 Princeton University patented the idea of smartphone-neurobehavioral testing which was licensed to Blinklab in 2021.
Princeton University is entitled to 2% of net sales from the technology, and 15% of any sublicense income. It has also received 450,000 shares in the company.
To date $4.4 million has been spent on development of the Blinklab technology.
The Technology
ASD is the development focus of Blinklab's diagnostic neurometric tests. The company has cited intentions to pursue ADHD, schizophrenia, as well as other neurodevelopmental conditions such as emotional disorders and neurodegenerative diseases.
ASD diagnosis and treatment of children in Australia has been the largest expenditure for the NDIS in Australia.
The Blinklab device consists of a smart-phone app (a front-end tool) and a portal (the back end). The device combines neuroscience, artificial intelligence (AI), and machine-learning.
The smartphone app can be used by patients, caregivers and/or parents to collect subject information and responses to the Blinklab tests in real time. The back-end portal is a secure, encrypted database and content-management system that allows full customisation and data analysis.
There have been eight relevant studies conducted to date since 2020. In a feasibility study in 280 subjects between four and 12 years of age, the sensitivity of the device for identifying ASD was 85% with a specificity of 84%.
An FDA registration study in 400 - 500 subjects is expected to start in the second half of this year and be completed in the first half of next year. An FDA approval submission is expected to be made mid next year with approval expected in early 2026 in the US.
Business model
Once Blinklab's device completes pivotal registration studies and receives market authorisation, it will be commercialised as Software as a Medical Device (SaMD). The device is not intended for use as a stand-alone diagnostic device but as an adjunct to the diagnostic process.
The Blinklab device will initially be developed and marketed as a tool to aid healthcare practitioners in the diagnosis and assessment of ASD. The test will be available for patients between 18-72 months of age at risk for developmental delay based on concerns of a parent, caregiver, or healthcare provider.
Later, Blinklab will also pursue approvals in other indications, such as ADHD and schizophrenia. Proof-of-concept is still required in neurodegenerative and emotional disorders. Programs in these other indications will follow the de novo FDA classification pathway.
Board and Management
The board of the company consists of Anton Uvarov (executive director), who identified the technology at Princeton University, Brian Leedman (non-executive chairman), Richard Hopkins (non-executive, formerly CEO of Phylogica, PharmAust and Zelira Therapeutics) and Jane Morgan (non-executive, founder of investment relations firm JMM).
The proposed CEO and founder of Blinklab is Dr Henk-Jan Boele, who is a medical doctor and neuroscientist. He will become full time CEO upon listing of the company. Dr Boele has been working on the technology at the Erasmus University Medical Center in the Netherlands from 2007 and at Princeton University since 2018.
Chairman Brian Leedman successfully founded and sold smartphone technology company ResApp Health to Pfizer in 2022 for $180 million.
Investors interested in subscribing to the Blinklab offer are required to read the company's prospectus which can be downloaded at www.blinklab.org
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