Slide 1: AI-Powered Smartphone Platform for Neurometric Testing
E A R L I E R A N D M O R E A C C U R AT E D I A G N O S I S O F A U T I S M A N D A D H D AN AI-POWERED SMARTPHONE P L AT F O R M F O R N E U R O M E T R I C T E S T I N G C O R P O R AT E P R E S E N TAT I O N · A S X : B B 1 · S E P T E M B E R 2 0 2 6
Slide 2: Disclaimer
Disclaimer This presentation has been prepared by BlinkLab Limited (ACN 652 901 703) (BlinkLab or Company) and contains background information about BlinkLab’s current operations at the date of this presentation. The presentation is in summary form and does not purport to be all inclusive or complet
Slide 3: Neuroscience – Artificial Intelligence – Mobile technology
Neuroscience – Artificial Intelligence – Mobile technology PRINCETON UNIVERSITY SPIN OUT · FOUNDED IN AUGUST 2021 · IPO IN APRIL 2024 Henk-Jan Boele, MD PhD Brian Leedman, MBA Anton Uvarov, PhD Richard Hopkins, PhD Samuel S.-H. Wang, PhD Peter Boele, MA Co-founder Non-Executive Co-founder Non-Execut
Slide 4: Share Price Growth Tracking Clinical Milestones
Share Price Growth Tracking Clinical Milestones F U L L B O A R D PA R T I C I PAT E D I N A L L C A P I TA L R A I S E S · F U L LY F U N D E D T O R E A C H C O M M E R C I A L S TA G E Shares on Issue Nov 2024 Oct 2025 Mar 2026 Aug 2026 Case-control autism results Autism pre-FDA pilot results FDA
Slide 5: Sensorimotor biomarkers have been widely studied in neuroscience
Sensorimotor biomarkers have been widely studied in neuroscience BUT CLINICAL ADOPTION HAS BEEN LIMITED BY TECHNICAL COMPLEXITY Objective measurements of brain circuit function Over 9,000 peer-reviewed studies across a wide range of neuropsychiatric Examples of laboratory-based assessments disorders
Slide 6: The BlinkLab Solution: Smartphone-based sensorimotor assessments
The BlinkLab Solution: Smartphone-based sensorimotor assessments W O R L D F I R S T · I N V E N T E D , PAT E N T E D A N D P U B L I S H E D B Y B L I N K L A B F O U N D E R S Minuscule facial reflexes, elicited by our app, Evokes Facial Reflexes generate a digital biomarker for autism and ADHD.
Slide 7: BlinkLab: How it works
BlinkLab: How it works REMOTE · CLINICAL GRADE · SCALABLE · ACCESSIBLE 1 2 3 Simple at-home set-up Short smartphone assessment Automated facial analysis Smartphone + headphones 10–15 minutes Selfie camera captures facial landmarks AI Algorithmic analysis of evoked neurometric responses Blink, facial
Slide 8: Our first product: BlinkLab Dx1
Our first product: BlinkLab Dx 1 D I A G N O S T I C A I D F O R A U T I S M A S S E S S M E N T · F D A 5 1 0 ( K ) R E G U L AT O R Y P R O G R A M O N G O I N G Early Clinical Regulatory Pilot Study Pivotal Study FDA 510(k) FDA Commercial Work1 Preparation2,3 Program4 Program5 Submission Clearanc
Slide 9: The growing need for scalable autism assessment
The growing need for scalable autism assessment R I S I N G G L O B A L P R E V A L E N C E · H I G H C O S T S · L I M I T E D C L I N I C A L C A PA C I T Y · L O N G WA I T L I S T Prevalence in children has grown to up to 3% in the US 1-3 Autism prevalence increases globally 4,5 (1) Center for D
Slide 10: Autism diagnosis still lacks an objective medical test
Autism diagnosis still lacks an objective medical test C U R R E N T LY N O B I O M A R K E R , S U C H A S A B L O O D T E S T O R B R A I N S C A N , U S E D I N C L I N I C A L P R A C T I C E . Diagnosis relies on behavioral assessments based on DSM-5 Over 100 autism questionnaires have been dev
Slide 11: Early diagnosis and intervention helps children develop crucial skills and reduces costs
Consensus: Early diagnosis and intervention helps children to develop crucial skills and reduces long-term support needs and costs Ø Early detection and diagnosis is crucial 1-5 The American Academy of Pediatrics recommends that all children must be screened for autism at ages 18 and 24 months. Ø Ea
Slide 12: BlinkLab could become an economic intervention reducing long-term autism care cost
BlinkLab is not only a diagnostic technology; it could become an economic intervention that helps reduce the long-term cost of autism care The Present: NDIS Autism Costs: A$9.9B The Future: Today’s diagnosed children become the wave of tomorrow’s adult cost In 2025 autism accounted for 41% of all ND
Slide 13: US autism assessments can cost US$1,200–$6,000+
US autism assessments can cost US$1,200–$6,000+ T R A D I T I O N A L D I A G N O S I S R E Q U I R E S M U LT I P L E S P E C I A L I S T S A N D E X T E N S I V E R E P O R T I N G T I M E Average self-pay cost by evaluation tier WITH COMMERCIAL INSURANCE Indicative US pricing before insurance US$
Slide 14: US Pilot Study Confirms High Diagnostic Accuracy and FDA Trial Readiness
US Pilot Study Confirms High Diagnostic Accuracy and FDA Trial Readiness BLINKLAB DX1 U.S. PILOT STUDY IN AUTISM · UNBLINDED 17 OCTOBER 2025 84% SENSITIVITY 85% SPECIFICITY 485 CHILDREN ENROLLED, AGED 2–11 FDA endorsed the pivotal 510(k) design Tested in a real-world clinical population At a formal
Slide 15: Why 100% sensitivity and 100% specificity is impossible
Why 100% sensitivity and 100% specificity is impossible PERFORMANCE CEILING IS 85-90% DUE TO DIAGNOSTIC AMBIGUITY AND AUTISM HETEROGENEITY 1st Evaluation Re-evaluation Diagnostic Stability Few years later... Autism clinical diagnostic stability is estimated around 80-90% stability. ¹⁻⁵ 2 years old 8
Slide 16: BlinkLab Commenced Pivotal Validation Program
BlinkLab Commenced Pivotal Validation Program F D A 5 1 0 ( K ) S U B M I S S I O N · F I R S T PA R T I C PA N T E N R O L L E D I N M A R C H 2 0 2 6 · S U B M I S S I O N E A R LY 2 0 2 7 Ten Leading US Autism Centers will Participate in the 510(k) Pivotal Study Prospective, multicenter in US, do
Slide 17: Dx1 is prescribed when developmental concerns warrant autism assessment
Dx1 is prescribed when developmental concerns warrant autism assessment A C L I N I C I A N - P R E S C R I B E D D I A G N O S T I C A I D · N O T A S TA N D - A L O N E T E S T Potential prescription triggers Concerns do not need to be autism-specific 1 Healthcare provider observation Developmenta
Slide 18: We follow a conventional revenue model for medical devices
We follow a conventional revenue model for medical devices B2B PRESCRIPTION SaMD (SOFTWARE as MEDICAL DEVICE) · PAY PER ASSESSMENT What a clinic pays How we sell BlinkLab Dx1 TBD Prescription device, sold to providers Not a consumer app and not direct to consumer. The prescribing clinician is the 30
Slide 19: US commercialization strategy following FDA clearance
US commercialization strategy following FDA clearance S P E C I A L I S T- F I R S T L A U N C H · S C R E E N I N G A S A S E P A R A T E L A B E L E X P A N S I O N 2027 2028 2029 2030 2031+ COMMERCIAL ADOPTION INITIAL DIAGNOSTIC AID Launch readiness Late-2027 paid lighthouse launch Specialist and
Slide 20: KOL engagement has been the strategy from day one
KOL engagement has been the strategy from day one KEY OPION LEADERS · WE HAVE BEEN IN THIS FIELD FOR DECADES · WE’RE NOT SELLING INTO IT May 2024 Turning Pointe Autism Foundation, USA First US partnership after IPO. Jul 2024 Mental Care Group, Netherlands The Dx2 ADHD model. Nov 2024 Monash Universi
Slide 21: Our second product: BlinkLab Dx2
Our second product: BlinkLab Dx 2 DIAGNOSTIC AID FOR ADHD ASSESSMENT · SAME SMARTPHONE TECH AS DX1 · DIFFERENT USE CASE Early Clinical Regulatory Pilot Study Pivotal Study FDA FDA Commercial Work1 Preparation2 Program Program Submission Clearance Launch Regulatory Pipeline for BlinkLab Dx2 BlinkLab
Slide 22: The unmet need in ADHD is diagnostic
The unmet need in ADHD is diagnostic 7 MI L L I O N U S C H I L D R E N · 5 6 % O F A D U L T S D I A G N O S E D A F T E R 1 8 · N O O B J E C T I V E T E S T United States: prevalence keeps climbing 1-3 Australia: an 11-fold increase in ADHD medication prescribed 4-7 11.0% 11.4% 22 9.5% 7.8% Child
Slide 23: ADHD assessment is costly and already shifting online
ADHD assessment is costly and already shifting online U S E V A L U AT I O N S C A N C O S T U S $ 2 0 0 – $ 5 , 0 0 0 + ; T E L E H E A LT H I S A L R E A D Y E M B E D D E D I N A D U LT A D H D C A R E ADHD CARE IS ALREADY DIGITAL Average cost by evaluation tier Indicative US pricing; patient cos
Slide 24: European ADHD study delivers positive results
European ADHD study delivers positive results E X PA N D I N G O U R P L AT F O R M B E Y O N D A U T I S M · F I R S T S T E P T O WA R D S B L I N K L A B D x 2 · W O R L D F I R S T 82% SENSITIVITY 83% SPECIFICITY 208 CHILDREN, AGED 6–17 Foundation for BlinkLab Dx2 One of the largest ADHD case-co
Slide 25: Our expanding clinical study portfolio
Our expanding clinical study portfolio N I N E E X P L O R AT O R Y P R O G R A M S · F O U R R E A D O U T S I N C Y 2 0 2 6 , F I V E I N C Y 2 0 2 7 Early Clinical Regulatory Pilot Study Pivotal Study FDA FDA Commercial Work1 Preparation2 Program Program Submission Clearance Launch Regulatory pip
Slide 26: A deep, global and now granted patent estate
A deep, global and now granted patent estate F O U R P A T E N T F A MI L I E S · 3 0 F I L I N G S · S E V E N J U R I S D I C T I O N S · F I R S T U S P A T E N T G R A N T E D J U N E 2 0 2 6 4 30 21 7 CY2041+ PATENT FAMILIES FILINGS WORLDWIDE LIVE APPLICATIONS JURISDICTIONS PROTECTION RUNWAY Pr
Slide 27: For more info, please contact:
For more info, please contact: Brian Leedman Henk-Jan Boele, MD, PhD Non-Executive Chairman Co-founder and MD/CEO brian@blinklab.org henkjan@blinklab.org M: +61 (0) 412 281 780 M: +31 (0) 611 132 247 info@blinklab.org BlinkLab Limited (ASX:BB1) @BlinkLab Ltd @BlinkLab2193 @BlinkLab.App B L I NKL A B