UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D) OF THE
SECURITIES EXCHANGE ACT OF 1934
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Check the appropriate box below if the Form 8-K is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Securities registered pursuant to Section 12(b) of the Act:
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| The Stock Market LLC | ||||
| The Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
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mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act.
Item 7.01. Regulation FD Disclosure.
On August 13, 2024, the Company posted an investor presentation to its website at www.spectral-ai.com (the “Investor Presentation”). A copy of the Investor Presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. The Company expects to use the Investor Presentation, in whole or in part, and possibly with modifications, in connection with presentations to investors, analysts and others.
The information in this Item 7.01 to this Current Report on Form 8-K, and in Exhibit 99.1 furnished herewith, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Spectral AI Investor Presentation, dated August 13, 2024. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this Current Report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: August 13, 2024
| SPECTRAL AI, INC. | ||
| By: | /s/ Peter M. Carlson | |
| Name: | Peter M. Carlson | |
| Title: | Chief Executive Officer | |
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Exhibit 99.1
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
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 Headquarters Dallas, TX Strong competitive barriers to entry Founded 2009 NASDAQ MDAI Annual Revenue 2023 E $ 1 8M 202 4E $ 2 8M F i n a n c i a l p o s i t i o n a t 6 / 3 0 / 2 0 2 4 Cash $6.9M Intellectual property portfolio 26 issued 38 pending Large and growing addressable markets Burn DFU A B O U T 1
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 e d Equity Facility Strengthened Board and Management Team Joined Russell Microcap Index $13.8 Million in Revenue for H1 2024 2
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 ourselves for near - term commercial success. • Product prototyping • Pre - sub regulatory alignment 20 13 - 2024 D ee p V i e w i s a single platform supporting multiple indications. Extensive portfolio of patents, trade secrets and “truthed” images are a significant barrier to competition. 3 Revolutionizing Wound Care Our DeepView system enables healthcare providers to make more informed treatment choices. In a matter of seconds during the initial patient visit, DeepView predicts ¹ if the wound will heal or not , with remarkable accuracy .
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 features, such as tissue characteristics that determine health C o m b i n e d w i t h p a t i e nt health matrix data A I m o d e l t ra i n e d a n d tested against a proprietary clinical database of 340+bn³ clinically validated data points A I a l g o r i t h m i n t e g ra t e s i m a g e a n d c l i n i c a l d a t a for model training AI model building Accurate and immediate binary wound healing prediction in seconds Predicting t o m o r r o w ’ s o u t c o m e today Healing prediction Non - healing output Decision: surgery or advanced wound care products Healing output D e c i s i o n : R o u t i ne c a r e 4
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 e s ell i n g 2024 2026 D e e p V i e w S n a p S h o t ® M | H a n d h e l d Military anticipate selling INDICATIONS 2 0 2 6 2 0 27 Diabetic Foot Ulcer T A M $ 11 B ¹ ⁸ - A n t i c i p a t e s e ll i n g 5 2027 Total grant a warded $7.1M for miniaturization of technology
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
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 site analysis on MSI, machine learning and healthcare matrix • DFU healing potential prediction and wound assessment on MSI, machine learning and healthcare matrix • High - precision, multi - aperture, M S I s n a p s h o t i m a g i n g • W o u n d a ss e s s m e n t o n MSI, optical, biomarkers, a n d m a c h i n e l e a r n i n g • Burn/Histology assessment on MSI and machine learning • High - precision single aperture snapshot imaging with multiplexed illumination • Topological characterization and assessment of tissue including wounds, using MSI and machine learning ACTIVE MANAGEMENT OF IP PORTFOLIO • U s e f u l l i f e o n k e y p a t en t p r o t e c t i o n o n c o r e concepts exceeds 14 years • Proprietary physician review image library for Burn and DFU • E n g a g e l e a d i n g e x p e r t s t o c o n s t a n t l y e v a l u a te IP strategy and execution 38 Pending U.S. & I n t e r n at i o n a l p a t e nt applications 26 U . S . & I n t e r n at i o n a l Patents issued and allowed 7
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 to determine need for surgery.⁶ PROBLEM No existing diagnostic t o o l f o r b u r n l e a d i n g t o uninformed decisions. B u r n e v a l u a t i o n r e l i e s o n visual examination and subjective judgement, often leading to inaccuracies. OUR S O L U T I O N Burn professional healing accuracy prediction is 7 5 % ( s p e c i a l i s t ) . 8
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 n t o f E n t ry i n t o H e a l t h S y s t e m Infrequent, yet impactful in triage scenario More time due to major comorbidities Size and location of ulcer 1 2 3 4 Unmet need in battlefield use Proof of concept for broader commercialization Miniaturization gains global access to sites of service US Military Handheld 9
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: T i m e M o n e y Patient outcomes AI methodology & m a c h i n e l e a r n i n g 10 Impacting patient outcomes Provider behavior change D e N o v o / 5 1 0 k C A M a r k M a r k
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 for burns¹⁴ ¹⁶ (>30% reduction in LOS) VALUE PROPOSITION AND ANTICIPATED SYSTEMWIDE BENEFITS B u r n Standardized Wound Measurement for TBSA D e c r e a se U nn e c e ss a ry Transfers D e c r e a se T i m e t o Surgery D e c r e a se U nn e c e ss a ry Surgery Initial penetration in United Kingdom market generates early proof of clinical benefits 11
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 r a p h y ( U . S . , U K , E M E A ) . 2025+ Procurement Contract Options 2023 PBS Contract Base 2019 Burn II 2013 Burn I $95M $55M $75M $26M Commercialization Procurement Regulatory Manufacturing C o m m e r c i a l Readiness Research Testing Proof of Concept $ 250M TOTAL 12
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%+ Completed Anticipated Enrollment Completion: April 2025 Why are they unique? 125 burn centers with 250 burn surgeons nationwide High complexity and high volume of cases Frequent exposure to all burn wound types Why are they unique? 5,000 Emergency Departments with no burn specialized training Infrequent exposure to burn severity
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 i t y S E L L I N G 14
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 revenue beginning no later than 2Q26 UK DeepView Commercialization • Anticipated initial sales are a three - year bundled total, including a leased monthly payment • Multiple care settings, such as Trauma and A&E, being targeted U.S. DeepView Commercialization • Initial sales will also be focused on developing real - world evidence (RWE) • Ongoing pricing per click and device sales being evaluated o Annuity payment with and without device one time sale o Reimbursement being developed Additional Revenue Sources • Global expansion following US De Novo Clearance • Annuity payment from AI licensing fees 15
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 % O w n e d 1 00 % O w n e d 1 00 % O w n e d
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 s a n d c a r e g i v er b u r d e n • R e d u c e d i n f e c t i o n a n d t r e a t m e n t c o m p l i c a t i o n s • Reduced pain and suffering Payers • E l i m i n a t e d u n n e c e s s a r y payments • Objective and validated t r e a t m e n t s u pp o r t REDUCING LENGTH OF STAY SYSTEMWIDE BENEFITS IMPROVED PATIENT OUTCOMES DECREASED COSTS PER INPATIENT IMPROVED E X P E R I E N CE INNOVATION J U S T I F I C A T I ON 18
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 - Term Commercial Opportunities Experienced M a n a g e m e n t Team 19
Appendix Financials P a t e n t s 20
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 u r r e n t A s s e t s 11,661 14,884 9,902 11,356 11,841 13,328 T o t a l C u r r e n t A s s e t s 2,236 599 790 975 1,157 854 N o n - c u r r e n t A s s e t s 13,897 15,483 10,692 12,331 12,998 14,182 T o t a l A ss e t s 2,403 3,306 2,683 3,275 2,654 2,018 A cc o u n t s P a y a b l e 2,733 3,818 4,300 3,983 2,394 2,361 A cc r u e d E x p e n s e s 10,990 10,387 5,418 3,389 1,476 975 O t h e r C u r r e n t L i a b i l i t i e s 16,126 17,511 12,401 10,647 6,524 5,354 T o t a l C u r r e n t L i a b i l i t i e s 2,036 - - 228 452 142 N o n - c u r r e n t L i a b i l i t i e s 18,162 17,511 12,401 10,875 6,976 5,496 T o t a l L i a b i l i t i e s (4,265) (2,028) (1,709) 1,456 6,022 8,686 S t o c k h o l d e r s ’ E q u i t y ( D e f i c i t ) 13,897 15,483 10,692 12,331 12,998 14,182 T o t a l L i a b i l i t i e s a n d S t o c k h o l d e r s ’ E q u i t y 21
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 2,945 2,436 1,472 1,791 2,181 G r o s s P r o f i t 5,756 5,088 5,365 5,638 4,782 5,079 O p e r a t i n g E x p e n s e s (2,442) (2,143) (2,929) (4,166) (2,991) (2,898) O p e r a t i n g I n c o m e ( L o s s ) - (848) - (7,604) - - T r a n s a c t i o n C o s t s (353) (192) (638) 1,087 (39) (665) O t h e r I n c o m e ( E x p e n s e ) (2,795) (3,183) (3,567) (10,683) (3,030) (3,563) L o s s Be f o r e I n c o m e T a x e 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 ) B e n e f i t (2,864) (3,205) (3,546) (10,629) (3,070) (3,609) N e t L o s s (0.16) (0.19) (0.22) (0.77) (0.23) (0.27) N e t L o s s p e r S h a r e 17,598,357 16,560,298 16,097,399 13,822,990 13,210,320 13,190,635 N u m b e r o f s h a r e s o / s 22
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 132 188 183 180 177 173 A m o r t i z a t i o n o f R i g h t - o f - U s e A s s e t s - - 2,550 1,800 - - I s s u a n c e o f S h a r e s f o r T r a n s a c t i o n C o s t s - - (2,550) 2,550 - - Commitment to issue shares for transaction cost (348) (20) 669 (1,069) 81 (16) C h a n g e i n F a i r V a l u e o f w a r r a n t l i a b i l i t i e s 167 (66) - - - - C h a n g e i n f a i r v a l u e o f n o t e s p a y a b l e 225 147 - - - - C o s t f r o m i s s u a n c e c o m m o n s t o c k (57) 102 (1,032) (381) 468 500 C h a n g e s i n A s s e t s (3,021) (112) 1,081 1,930 173 (1,105) C h a n g e s i n L i a b i l i t i e s (5,362) (2,680) (2,375) (5,338) (1,772) (3,755) Net Cash Used in Operating Activities - - - - - - N e t C a s h U s e d i n I n v e s t i n g A c t i v i t i e s 2,667 - 3,351 - - P r o c ee d s f r o m I s s u a n c e o f C o m m o n S t o c k - - - 660 - - Cash Received in Business Combination (2,518) (218) 288 (113) (71) (104) P a y m e n t s f o r N o t e s P a y a b l e 1,000 - - - - Proceeds from Notes payable – related party 4,600 4,600 (483) - - - P r o c ee d s f r o m N o t e s p a y a b l e - - - 306 (306) - P a y m e n t s o f d e f e r r e d o ff e r i n g c o s t s - - 316 - - S t o c k O p t i o n E x e r c i s e s 2,082 8,049 (195) 4,520 (377) (104) Net Cash Provided By (Used In) Financing Activities (2) 12 - (1) 1 E ff e c t o f E x c h a n g e R a t e C h a n g e s o n C a s h (3,280) 5,367 (2,558) (818) (2,150) (3,858) N e t I n c r e a s e ( D e c r e a s e ) i n C a s h 10,157 4,790 7,348 8,166 10,316 14,174 Be g i n n i n g C a s h Ba l a n c e 6,877 10,157 4,790 7,348 8,166 10,316 E n d i n g C a s h B a l a n c e 23
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 r e s t ( I n c o m e ) E x p e n s e (2,789) (3,197) (3,611) (10,725) (3,071) (3,608) EBIT 2 3 2 2 3 2 D e p r e c i a t i o n E x p e n s e (2,787) (3,194) (3,609) (10,723) (3,068) (3,606) EBITDA 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 699 276 - - - - B o r r o w i n g r e l a t e d c o s t s (348) (20) 669 (1,069) 81 (16) C h a n g e i n F a i r V a l u e o f W a r r a n t L i a b i l i t y 167 (66) - - - - C h a n g e i n f a i r v a l u e o f n o t e s p a y a b l e 9 16 13 24 - (13) Foreign Exchange Transaction (Gain) Loss (180) 848 - 7,604 738 - O t h e r i n c o m e ( e x p e n s e s ) i n c l . T r a n s a c t i o n C o s t s (2,038) (1,857) (2,659) (3,885) (1,853) (3,335) A d j u s t e d E B I T D A 24
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
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 at Sauvegarder Investment Management with e x t e n s i v e b a c k g r o u n d in investment banking. M a r ti n M e l l i s h Founding director of Aspen Advisory Services Ltd. Deepak S a d a g o p a n Serves as COO of Population Health at Providence, and CEO of Health Connect Partners, LLC. Peter M. Carlson Prior to becoming CEO of Spectral AI, served as CFO since January 2024. Prior to Spectral AI, was CFO of MiMedx Group, Inc. D r . J . M i c h a e l DiMaio 24+ years of experience in cardiothoracic surgery, and Chief of Staff at Baylor Scott & White supervising more than 650 physicians. 26
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 C o n s u l t a n t B u r n , L a s er a n d Reconstructive Surgeon at the Northern Regional Burn Centre based at Newcastle’s Royal Victoria Infirmary, with a special interest in emergency burn care, reconstruction and laser treatment. DeepView will significantly transform how we treat DFUs through continuous monitoring and measurement ensuring an accelerated healing trajectory and prevent DFU reoccurrence . PROF. PAUL CHADWICK EVP of UK and EMEA F o r m e r C E O o f t h e R o y a l C o ll e g e o f P o d i at r y U K Prof. Chadwick is a world - renowned clinical research scientist, wound care key opinion leader (KOL), and has an extensive publication record on diabetic wound management. 27
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 approved Proof of Concept Clinical Study 5. Clinicians are 50% accurate in assessing healing potential of DFUs https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7950518/ 6. Anyanwu JA, Cindass R. Burn Debridement, Grafting, and Reconstruction. [Updated 2023 May 29]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan - . Available from: https://www.ncbi.nlm.nih.gov/books/NBK551717/ 7. Assessment of burn depth and burn wound healing potential. Burns. Volume 34 - 6. September 2008, pages 761 - 769 8. Huson HB, Phelan HA, G'Sell DJ, Smith S, Carter JE. If Seeing Was Believing A Retrospective Analysis of Potential Reduced Treatment Delays with a Novel Burn Wound Assessment Device. JBCR 2021;(42)S117 - 18 9. Definitive Healthcare 2019 Private Pay and CMS pay of inpatient versus outpatient DRG codes 10 . The Effectiveness of Regionalized Burn Care : An Analysis of 6 , 873 Burn Admissions in North Carolina from 2000 to 2007 . Regional Air Transport of Burn Patients : A Case for Telemedicine? 1 1 . W a r r i n er R , S n y d er R J , C a r di n a l M H e t a l ( 2 0 11 ) D i f f e r e n t i a t i n g di a b e t i c f oo t u l c e r s t h a t a re u n l i k e l y t o he a l b y 1 2 w ee k s f o l l o w i n g a c h i e v i n g 50% percent area reduction at 4 weeks. Int Wound J 8(6):632 – 7. https://doi.org/10.1111/j.1742 - 481x.2011.00860.x 12. Sheenan P, Jones P et al (2003) Percent change in wound area of diabetic foot ulcers over a 4 - week period is a robust predictor of complete healing in a 12 - week prospective trial. Diabetes Care 26(6):1879 – 82 https://doi.org/10.2337/diacare.26.6.1879 13. Carter NH, Leonard C, Rae L. Assessment of Outreach by a Regional Burn Center: Could Referral Criteria Revision Help with Utilization of Resources? JBCRi2018;39(2):245 - 51 14. Definitive Healthcare 2019 Cost and Claims Data from Medicare and Private Payer Estimates 15. American Medical Association Common Procedural Terminology CPT® 16. Huson HB, Phelan HA, G'Sell DJ, Smith S, Carter JE. If Seeing Was Believing A Retrospective Analysis of Potential Reduced Treatment Delays with a Novel Burn Wound Assessment Device. JBCR 2021;(42)S117 - 18. 17. TAM and CAGR – Global Burn Care Market Size & Share Report, 2021 - 2028 18. TAM and CAGR – Fortune Business Insights: Diabetic Foot Ulcer Treatment Market Worth $11.16 Billion at 6.8% CAGR; Rise in Clinical Trials to Augment Market
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, including but not limited to our plans and projected timelines to begin commercialization and product sales, launch new products, complete clinical trials, add additional clinical indications, (ii) the ability to be listed on the Nasdaq Global Market, (iii) Spectral AI’s managements’ expectations, (iv) potential government contracts, (v) expected beneficial outcomes and synergies, (vi) potential financing opportunities, (vii) Spectral AI’s regulatory pathway for and timing of FDA, CE and UKCA regulatory submissions and approvals, (viii) Spectral AI’s U . S . government contracts and future awards, (ix) the total anticipated target markets for burn wound and diabetic foot ulcers, (x) possible competitors, (xi) potential future indications and applications for DeepView and areas of interest supported by BARDA, (xii) Spectral AI’s future and pending U . S . patent applications and foreign and international patent applications, and (xiii) pro forma information and other estimated values . The foregoing list of risk factors is not exhaustive . Management believes that these forward - looking statements are reasonable as and when made . However, such forward - looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those projected in the forward - looking statements . These risks and uncertainties include but are not limited to our ability to obtain and maintain necessary regulatory approvals, general economic conditions, consumer demand for our products and services, challenges relating to entering into and growing new business lines, the competitive environment, and the risk factors listed from time to time in our Annual Reports on Form 10 - K, Quarterly Reports on Form 10 - Q, the Registration Statement on Form S - 1 , as amended, filed with the SEC on April 10 , 2024 and any other SEC filings including the sections entitled “Cautionary Note Regarding Forward - Looking Statements”, “Cautionary Note Regarding Forward - Looking Statements and Risk Factor Summary”, “Risk Factors”, “Management’s Discussions and Analysis of Financial Condition and Results of Operations” and “Business” and in the Financial Statements . The Company undertakes no obligation to update forward - looking statements except as required by applicable securities laws . Readers are cautioned that forward - looking statements are not guarantees of future performance and are cautioned not to place undue reliance on any forward - looking statements . Any financial projections in this presentation are forward - looking statements that are based on assumptions that are inherently subject to significant uncertainties and contingencies, many of which are beyond Spectral AI’s control . While all projections are necessarily speculative, Spectral AI believes that the preparation of prospective financial information involves increasingly higher levels of uncertainty the further out the projection extends from the date of preparation . The assumptions and estimates underlying the projected results are inherently uncertain and are subject to a wide variety of significant business, economic and competitive risks and uncertainties that could cause actual results to differ materially from those contained in the projections . The inclusion of projections in this communication should not be regarded as an indication that Spectral AI, or its representatives, considered or consider the projections to be a reliable prediction of future events . Annualized, pro forma, projected and estimated numbers are used for illustrative purpose only, are not forecasts and may not reflect actual results . 29
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, without charge, at the SEC's website at www.sec.gov. No Offer or Solicitation This presentation and the information contained herein do not constitute (i) (a) a solicitation of a proxy, consent or authorization with respect to any securities or (b) an offer to sell or the solicitation of an offer to buy any security, commodity or instrument or related derivative, nor shall there be any sale of securities in any jurisdiction in which the offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction or (ii) an offer or commitment to lend, syndicate or arrange a financing, underwrite or purchase or act as an agent or advisor or in any other capacity with respect to any transaction, or commit capital, or to participate in any trading strategies. No offer of securities in the United States or to or for the account or benefit of U.S. persons (as defined in Regulation S under the U.S. Securities Act) shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act, or an exemption therefrom. Investors should consult with their counsel as to the applicable requirements for a purchaser to avail itself of any exemption under the Securities Act. Trademarks All trademarks, logos and brand names are the property of their respective owners. All company, product and service names used in this presentation are for identification purposes only. Use of these names, trademarks and brands does not imply endorsement. 30 Disclaimers
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