Spectral Ai, Inc. · NASDAQ:MDAI
Spectral Ai — Investor Presentation (August 2024)
32 slides from Spectral Ai's investor presentation, Aug 13, 2024
Slide 1: Predictive Wound Healing AI + Multispectral Imaging
Predictive Wound Healing AI + Multispectral Imaging = Faster, More Accurate Treatment Decisions in Healthcare N a s d a q: M D A I | A u g u s t 2 0 2 4
Slide 2: AI-Driven wound assessment technology across the healthcare continuum
A I - D r i v e n w o u n d assessment technology designed to deliver value across the healthcare continuum 17.6 Million shares outstanding August 9, 2024 S u pp o r t e d b y $ 2 5 0 M + non - dilutive government funding C l e a r r e g u l a t o r y pathway Limited c o m p e t i t i o n Headquarte
Slide 3: Recent Accomplishments
R e c e n t A cc o m p l i sh m e n t s SINCE JANUARY 2024 Completed 100% Pediatric Burn Center Enrollment PolyNovo MOU to support Australian Special Access Scheme (SAS) Additional Patent Grants for Total Number of 26 Received Burn - AI for UKCA classification Secured $10.0 M i ll i o n C omm i t t
Slide 4: Delivering on Commitments - Revolutionizing Wound Care
Delivering on Commitments 1 1 - y e a r t r a c k r e c o r d of meeting milestones validated by $250M non - dilutive government funding • Proof of concept • C l i n i c a l v a l id a t i o n • P r o d u c t v a l id a t i o n Prioritizing growth opportunities in profitable markets, positioning our
Slide 5: DeepView Imaging
DeepView Imaging Patented proprietary multi - spectral imaging data acquisition in milliseconds Capturing injured tissue spectral signature Covering visible near UV t h r o u g h v i s i b l e s p e c t r u m and into near - IR light OUR TECHNOLOGY D a t a e x t r a c t i o n Extraction of AI model
Slide 6: One Imaging Platform, Multiple Indications
One Imaging Platform, M u l t i p l e I n d i c a t i on s P o t e n t i a l C l i n ic a l Indications Wound Bed Preparedness Amputation Digital Guided Therapy Critical Limb Ischemia M i n i a t u r i z e d Mobile H o m e H e a l t h c a r e B u r n W o u n d T A M $ 3 . 7 B ¹ ⁷ - A n t i c i p a t
Slide 7: Targeting Multiple Care Centers
Community Nursing 500 I C S F o o t & A n k l e 40 F oo t P r o t e c t i o n Service 150 A&E 230 Trauma Centres 25 Burn Centres 40 T a r g e t i n g M u l t i p l e C a r e C e n t e r s Podiatry 4,000+ Wound Care Centers 1,100 T r a u m a 1 – 3 / E D U n i t s 5,000 Burn Centers 125 Burn DFU 6
Slide 8: Intellectual property formidable barrier to entry
Active patent application families protecting our current and anticipated future business U . S. A N D G L O B A L I P I n t elle c t u a l p r o p e r t y f o r m i d a b l e b a r r i e r t o e n t r y • Burn/Wound classification on MSI and PPG • Tissue classification on MSI and PPG • Amputation s
Slide 9: Burn
B u r n A N T I CI P A T E D BENEFITS • Reduces time to surgery⁸ • Avoids unnecessary surgeries⁹ • Reduced transfers that can be treated locally • Uniformed standardized TBSA measurements CURRENT S O L U T I O N Wait and See as Tissue Changes to Know Severity Standard of care is to wait up to 7 days
Slide 10: US Commercialization Sequence
U S C o mm e r c i a l i z a t i o n S e q u e n c e US Emergency Departments Diabetic Foot Ulcer Revenue Focus US Burn Centers 2 0 2 6 2 0 2 6 / 2 0 2 7 2 0 2 7 2 0 2 6 / 2 0 2 7 Why Expert's adoption of technology Achieving BARDA contract milestones Key global feature of TBSA drives adoption P o i
Slide 11: Market Access: Key Steps to Successful Global Market Access
M A R K E T A C C E SS K e y S t e p s t o S u cc e s s f u l G l o b a l M a r k e t A cc e s s R e i m b u r s e m e n t CPTIII code Anticipated 2026 CPTI code Build on market penetration to deliver required evidence package Regulatory P u b l i c a t i o n s Health Economics Measuring ROI across:
Slide 12: Clinical evidence quantifies health system benefits
Clinical evidence quantifies health system benefits A n t i c i p a t e d B e n e f i t s • Standardized total body surface area (TBSA) measurement • 41% reduction in unnecessary transfer¹³ • Unnecessary surgery admission costs reduction per patient of $58,315¹⁴ ¹⁵ • 3+ day reduction time to surgery
Slide 13: BARDA Support Over the Years
BARDA SUPPORT OVER THE YEARS Management’s track record through years of BARDA e n g a g e m e n t v a l i d a t e s a n d i n c r e a s e s p r o b a b i l i t y o f s u c c e s s f o r D ee p V i e w a c r o s s c l i n i c a l i n d i c a t i o n s ( B u r n a n d D F U / O t he r ) a n d g e o g
Slide 14: Clinical Trial Update
C l i n i c a l T r i a l U p d a t e CURRENTLY 16 CLINICAL RESEARCH SITES SPREAD ACROSS THE US ENROLLING TO COMPLETE PIVOTAL TRIAL Burn Center Total Enrollment Goal: 160 85%+ Completed Anticipated Enrollment Completion: September 2024 13 Emergency Departments Total Enrollment Goal: 160 15%+ Complet
Slide 15: Product deployment and regulatory timeline
2024 2025 2026 2027 2028 Product H2 H1 H2 H1 H2 H1 H2 H1 H2 Burn CTR ED B u r n C T R Trauma Planned near - term p r o d u c t d e p l o y m e n t s Real - world Evidence R W E Pivotal Studies & Market Readiness P S&MR Anticipated Regulatory Authorization R E G B e g i n c o mm e r c i a l a c t i v
Slide 16: Revenue Opportunity
REVENUE OPPORTUNITY I n c l u d e s A I annuity and one - time d e v i c e s a l e s © 2 0 2 4 S p e c t r a l A I Research and Development • BARDA PBS Contract includes $55M R&D revenue spread across 4Q23 - 1Q26 • Modest additional R&D revenue from MTEC in 2024 • BARDA PBS Contract anticipates $95M
Slide 17: Spectral IP Subsidiary Organization Structure
S p e c t r a l I P S u b s i d i a r y ORGANIZATION STRUCTURE FACILITATES GLOBAL DISTRIBUTION 17 Spectral AI, Inc USA (DE) Parent Entity Spectral IP, Inc USA (DE) Spectral MD, Inc USA (DE) US Operating Entity Spectral DeepView Limited Ireland Spectral MD UK Ltd UK © 2 0 2 4 S p e c t r a l A I 1 00
Slide 18: Improving health and cost outcomes for all
Improving health and cost outcomes for all Clinician • Informed treatment decisions • Increased efficiency Care Facility • Uniformed clinical decisions • Equality of care • Improved efficiency • Go v e r n m en t d i g i t a l i n i t i a t i v e s Patient • Reduced treatment time for p a t i e n t
Slide 19: Investment Summary
I n v e s t m e n t S u m m a r y A I - D r i v e n C l i n i c a l Diagnostics FDA Breakthrough Designation Strong C o m p e t i t i v e Barriers S ys t e m w i d e Benefits Identified Regulatory Pathway Universal Platform for Additional Clinical Indications L a r g e & G r o w i n g Markets Near -
Slide 20: Appendix
Appendix Financials P a t e n t s 20
Slide 21: Summary balance sheets
S u mm a r y b a l a n c e s h e e t s Ǫ 2 2 0 2 4 Ǫ 1 2 0 2 4 Ǫ 4 2 0 2 3 Ǫ 3 2 0 2 3 Ǫ 2 2 0 2 3 Ǫ 1 2 0 2 3 $ t h o u s a n ds 6,877 10,157 4,790 7,348 8,166 10,316 Cash 2,295 1,828 2,346 1,312 1,520 1,884 A cc o u n t s r e c e i v a b l e , n e t 2,489 2,899 2,766 2,696 2,155 1,128 O t h e r C
Slide 22: Summary income statements
S u mm a r y income s t a t e m e n t s Ǫ 2 2 0 2 4 Ǫ 1 2 0 2 4 Ǫ 4 2 0 2 3 Ǫ 3 2 0 2 3 Ǫ 2 2 0 2 3 Ǫ 1 2 0 2 3 $ thousands (except per share data) 7,478 6,326 5,287 3,440 4,251 5,078 Research and Development Revenue (4,164) (3,381) (2,851) (1,968) (2,460) (2,897) C o s t o f R e v e n u e 3,314 2,9
Slide 23: Summary cash flow statements
S u mm a r y c a s h f l o w s t a t e m e n t s Ǫ 2 2 0 2 4 Ǫ 1 2 0 2 4 Ǫ 4 2 0 2 3 Ǫ 3 2 0 2 3 Ǫ 2 2 0 2 3 Ǫ 1 2 0 2 3 $ t h o u s a n ds (2,864) (3,205) (3,546) (10,629) (3,070) (3,609) N e t L o s s 402 283 268 279 396 300 S t o c k - b a s e d C o m p e n s a t i o n 2 3 2 2 3 2 Depreciation 13
Slide 24: Non-GAAP reconciliation
N o n - G AA P reconciliation Ǫ 2 2 0 2 4 Ǫ 1 2 0 2 4 Ǫ 4 2 0 2 3 Ǫ 3 2 0 2 3 Ǫ 2 2 0 2 3 Ǫ 1 2 0 2 3 $ t h o u s a n ds (2,864) (3,205) (3,546) (10,629) (3,070) (3,609) N e t L o s s 69 22 (21) (54) 40 46 I n c o m e T a x P r o v i s i o n ( Be n e f i t ) 6 (14) (44) (42) (41) (45) N e t I n t e
Slide 25: Exceptional Team with Proven Track Record
E X C E P T I O N A L T E A M W I T H P R O V E N T R A CK R E CO R D © 2 0 2 4 S p e c t r a l A I 25
Slide 26: Board of Directors
BOARD Board of Directors R i c h a r d Cotton Financial Advisor to Novumgen Ltd., and held CFO positions at several medical companies. M a r ion S ny d e r Sr. Director Corporate Accounts at Shockwave Medical, and founder of Lakeview H e a l t h c a r e Consulting Erich Spangenberg Managing partner
Slide 27: Expert clinical guidance
E x p e r t c l i n i c a l g u i d a n c e The technology provides us with high quality photos and gives us a binary output in terms of whether we need to surgically remove an area of burned skin or whether it will heal. CHRIS LEWIS Consultant Burn Surgeon M r . C h r i s t o p her L e w i s i s a
Slide 28: Reference List
REFERENCE LIST 1. Data from Spectral MD’s IRB approved Proof of Concept Clinical Study 28 2. https://www.cnn.com/2023/08/09/weather/maui - county - wildfires - hurricane - dora/index.htm l 3 . P i x e l d a t a p er S p e c t r a l M D c l i n i c a l s t u di e s . 4. Data from Spectral MD’s IRB ap
Slide 29: Forward Looking Statements
FORWARD LOOKING STATEMENTS Except for the historical information contained herein, this document contains forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 , including statements regarding (i) our strategy, plans, objectives and initiatives, includ
Slide 30: Additional Information and Where to Find It
Caution – Investigational Device. Limited by Federal or U.S. Law to Investigational Use Additional Information and Where to Find It This presentation is provided for informational purposes only. Spectral AI investors and stockholders will be able to obtain copies of any documents filed with the SEC,
Slide 31: Connect with us
spectral - ai.com ir@spectral - ai.com C o n n e c t with us 31
Slide 32: Spectral AI - Seeing the Unknown
¥ Spectral AL Seeing the Unknown