0001213900-23-086606.txt : 20231114 0001213900-23-086606.hdr.sgml : 20231114 20231114120108 ACCESSION NUMBER: 0001213900-23-086606 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20231113 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20231114 DATE AS OF CHANGE: 20231114 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Spectral AI, Inc. CENTRAL INDEX KEY: 0001833498 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 000000000 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-40058 FILM NUMBER: 231403001 BUSINESS ADDRESS: STREET 1: 2515 MCKINNEY AVE #1000 CITY: DALLAS STATE: TX ZIP: 75201 BUSINESS PHONE: (212) 492-3000 MAIL ADDRESS: STREET 1: 2515 MCKINNEY AVE #1000 CITY: DALLAS STATE: TX ZIP: 75201 FORMER COMPANY: FORMER CONFORMED NAME: Rosecliff Acquisition Corp I DATE OF NAME CHANGE: 20201123 8-K 1 ea188358-8k_spectral.htm CURRENT REPORT
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

PURSUANT TO SECTION 13 OR 15(D) OF THE

SECURITIES EXCHANGE ACT OF 1934

 

Date of Report (Date of earliest event reported): November 13, 2023

 

SPECTRAL AI, INC.

(Exact name of registrant as specified in its charter)

 

Delaware   001-40058   85-3987148
(State or other jurisdiction
of incorporation)		   (Commission File Number)   (I.R.S. Employer
Identification No.)

 

2515 McKinney Avenue, Suite 1000

Dallas, Texas

   75201
(Address of principal executive offices)   (Zip Code)

 

(972) 499-4934

(Registrant’s telephone number, including area code)

 

Not Applicable

(Former name or former address, if changed since last report)

 

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:

 

☐Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

☐Pre-commencements communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbols   Name of each exchange on which registered
Common Stock, par value $0.0001 per share   MDAI   The Nasdaq Stock Market LLC
Redeemable Warrants, each whole warrant exercisable for one share of Common Stock, at an exercise price of $11.50 per share   MDAIW   The Nasdaq 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 ☒

 

If an emerging growth company, indicate by check 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 2.02 Results of Operations and Financial Condition.

 

On November 13, 2023, Spectral AI, Inc. issued an earnings press release announcing its financial results for the third quarter ended September 30, 2023, and announcing a conference call that was held at 8am (CST) on November 14, 2023, to discuss these results. A copy of the earnings release is furnished as Exhibit 99.1 and incorporated herein by reference.

 

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   Press Release issued by Spectral AI, Inc. on November 13, 2023

 

1

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Dated: November 14, 2023

 

  SPECTRAL AI, INC.
   
  By: /s/ Wensheng Fan
  Name: Wensheng Fan
  Title: Chief Executive Officer

 

 

2

 
 EX-99.1 2 ea188358ex99-1_spectral.htm PRESS RELEASE ISSUED BY SPECTRAL AI, INC. ON NOVEMBER 13, 2023

Exhibit 99.1

 

 

Spectral AI Announces 2023 Third Quarter Financial Results

 

Highlights Continuing Progress in Developing and Commercializing AI-Driven DeepView® System Wound Healing Assessment Technology

 

Affirms Full Year Revenue Guidance for 2023 and 2024

 

DALLAS, November 13, 2023 - Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced financial results for the third quarter ended September 30, 2023 (“Q3 2023”).

 

“This has been an extraordinary period for Spectral AI, highlighted by our September listing on Nasdaq, continued progress towards developing and commercializing our AI-Driven DeepView® System wound healing assessment platform for burn and diabetic foot ulcers (“DFU”), and the recent receipt of the largest contract in our history a $149 million award from the United States government to advance our DeepView® System for burn wound assessment,” said Wensheng Fan, CEO of Spectral AI.

 

“We believe that our DeepView® System is the only digital predictive medical diagnostic product that provides clinicians with an objective and immediate assessment of a wound’s healing potential through the application of AI. Multiple clinical studies have validated the efficacy of our DeepView® System in assessing - within seconds - whether a wound will heal on its own or will require medical intervention to do so. In the case of burn, where our DeepView® System’s current accuracy is 92% for adults and 88% for pediatrics, a non-healing assessment may suggest a surgical referral as well as determining which specific areas require excision and grafting. For DFU, where our DeepView® System’s accuracy is 86%, a non-healing assessment may justify the immediate use of advanced wound care therapy as opposed to the current ‘wait-and-see’ approach. In each case, our DeepView® System is designed to support clinicians in placing their patients on an informed, defined, and immediate path to healing, while improving outcomes, reducing hospital stays, and eliminating unnecessary expenses.”

 

Mr. Fan concluded, “We are preparing across all fronts for the commercial launch of our DeepView® System as early as 2024 following the receipt of necessary regulatory approvals. To that end, we remain on track to submit applications for FDA, UKCA, and CE mark approval for the DeepView® System DFU indication and 3D wound measurement in 2024 and for FDA and CE mark approval for the burn indication in 2025. As previously announced, we also expect 2024 revenue growth of approximately 60% from anticipated 2023 levels.”

 

 

 

Q3 2023 FINANCIAL RESULTS OVERVIEW

 

All comparisons are to the third quarter ended September 30, 2022 (“Q3 2022”) unless otherwise stated.

 

●Research & Development Revenue1 was $3.4 million compared to $7.0 million, primarily due to decreased research and development work performed pursuant to the BARDA Burn II contract as clinical trials under this contract were nearing completion. New patient enrollments in our BARDA clinical study declined as the Company is completing enrollment and transitioning to the closeout phase of the study.
  
●Cost of revenue declined by $1.8 million, or 48.4%, primarily due to decreased activity to fulfill the BARDA Burn II contract consistent with decreased Research & Development revenue.
  
●Gross margin declined to 42.8% from 45.9%, primarily due to the commencement of Phase II of the Medical Technology Enterprise Consortium (“MTEC”) contract, which has a lower gross margin than the BARDA Burn II contract.
  
●General & administrative expenses were $5.6 million compared to $3.5 million, the result of increased headcount required to support our organizational growth, and R&D initiatives associated largely with ongoing studies in support of planned regulatory applications for our DFU indication.
  
●Non-recurring transaction costs associated with the September 2023 consummation of the Company’s business combination that resulted in our Nasdaq listing were $7.6 million as compared to no such costs.
  
●Net loss was $(10.6) million, or $(0.77) per share, compared to a net loss of $(0.4) million, or $(0.03) per share. Net loss for Q3 2023 included the above-referenced $7.6 million in non-recurring transaction costs.
  
●Adjusted EBITDA loss was $(3.9) million compared to Adjusted EBITDA of $0.0 million.
  
●As of September 30, 2023, cash and cash equivalents totaled $7.3 million and the Company had no long-term debt.

 

2023 and 2024 Guidance

 

The Company is reiterating its revenue guidance of approximately $17.4 million for full year 2023 and approximately $28.0 million for full year 2024. Financial guidance for FY2024 does not reflect the material financial contributions the Company expects would result from the commercialization of our DeepView® System for DFU and 3D wound measurement following the receipt of necessary regulatory clearances.

 

Q3 2023 OPERATIONS OVERVIEW

 

Burn Indication

 

●Awarded a new contract from the U.S. Government valued at up to $149 million to support the clinical validation and FDA clearance of our DeepView® System for burn wound assessment. Together with the previous contracts, this brings total U.S. Government awards to the Company since 2019 to more than $246.0 million.

 

 

1Research and Development Revenue consisted primarily of funding from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services.

 

2

 

 

●Announced that the imaging component of the DeepView SnapShot® Wound Imaging System (“SnapShot®”) achieved UK Conformity Assessed (UKCA)-mark for use in the United Kingdom and Class 1 medical device classification with the United States Food and Drug Administration (FDA). The Company is now pursuing the approval of its integrated AI application to obtain both UKCA and FDA approval for the commercialization of the complete DeepView® System in the U.S. and around the world.

 

●Continued to pursue horizon indication uses of the DeepView® System by commencing Phase II design and development activities for DeepView SnapShot® M, a handheld, portable and wireless device capable of performing digital burn assessment in military and combat environments. The Company is advancing this product under a $4 million contract award in April 2023 from MTEC, a biomedical technology consortium working in partnership with the U.S. Department of Defense.

 

●Commenced enrolling an additional 150 adult and pediatric subjects across at least 15 clinical sites in the U.S. and EU to expand one of the largest, multi-center burn studies ever conducted, which the Company completed in Q2 2023. The results of this expanded study will allow the Company to complete the development of the AI algorithm for burn and support its applications for FDA and CE Mark approval for the DeepView® System burn indication, which are planned for 2025.

 

DFU Indication

 

●Added seven additional clinical sites to its third multi-center DFU validation study in the U.S. Data collected from this third study will be used to further test the wound healing prediction capability of our DeepView® System’s DFU healing prediction algorithm and support the Company’s applications for FDA, UCKA and CE Mark approval for our DeepView® System’s DFU indication, which is planned for 2024.

 

Corporate

 

●Completed the business combination with Rosecliff Acquisition Corp I, subsequent to which the Company commenced trading on Nasdaq on September 12, 2023 following its delisting from the AIM Market of the London Stock Exchange.
  
●Received ISO 13485 certification for the manufacture and distribution of the DeepView® System.
  
●Appointed healthcare services leader and population health expert Deepak Sadagopan, MHCDS, to its board of directors.
  
●Appointed Professor Paul Chadwick, former CEO of the Royal College of Podiatry UK, as Executive Vice President of the Company’s UK subsidiary where he will be responsible for the market expansion of our DeepView® System in the EMEA.

 

Conference Call

 

The Company will host a conference call on Tuesday, November 14, 2023 at 9:00 am Eastern Time to discuss the results. Investors interested in participating in the live call can dial:

 

●833-630-1956 - U.S.
  
●412-317-1837 - International

 

A simultaneous webcast of the call may be accessed online from the Events & Presentations section of the Investor Relations page of the Company’s website at https://investors.spectral-ai.com/news-events/events

 

3

 

 

About Spectral AI

 

Spectral AI, Inc. is a Dallas-based predictive AI company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, with initial applications involving patients with burns and diabetic foot ulcers. The Company is working to revolutionize the management of wound care by “Seeing the Unknown®” with its DeepView® System. DeepView® is a predictive diagnostic device that offers clinicians an objective and immediate assessment of a wound’s healing potential prior to treatment or other medical intervention. With algorithm-driven results and a goal of substantially exceeding the current standard of care in the future, DeepView® is expected to provide faster and more accurate treatment insight towards value care by improving patient outcomes and reducing healthcare costs. For more information about DeepView®, visit www.spectral-ai.com.

 

Forward Looking Statements

 

Certain statements made in this release are “forward looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s strategy, plans, objectives, initiatives and financial outlook. When used in this press release, the words “estimates,” “projected,” “expects,” “anticipates,” “forecasts,” “plans,” “intends,” “believes,” “seeks,” “may,” “will,” “should,” “future,” “propose” and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements.

 

These forward-looking statements are not guarantees of future performance, conditions, or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside Company’s control, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. As such, readers are cautioned not to place undue reliance on any forward-looking statements.

 

Investors should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” sections of the Company’s filings with the SEC, including the Registration Statement and the other documents filed by the Company. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements.

 

Contacts:  
   
Investors:  
   
Spectral AI The Equity Group
Vince Capone Devin Sullivan, Managing Director
General Counsel dsullivan@equityny.com
ir@spectral-ai.com  
  Conor Rodriguez, Analyst
  crodriguez@equityny.com
   
Media:  
   
Russo Partners  
David Schull Guillermo Ruiz, M.D., Ph.D.
Russo Partners Russo Partners
(858) 717-2310 (646) 218-4604
david.schull@russopartnersllc.com guillermo.ruiz@russopartnersllc.com

 

4

 

 

Spectral AI, Inc.
Unaudited Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)

 

   September 30,   December 31, 
   2023   2022 
Assets        
Current assets:        
Cash  $7,348   $14,174 
Accounts receivable, net   1,312    2,294 
Inventory   220    - 
Unbilled revenue   127    618 
Prepaid expenses   1,755    331 
Other current assets   594    270 
Total current assets   11,356    17,687 
           
Non-current assets:          
Property and equipment, net   14    21 
Right-of-use assets   961    1,008 
Total Assets  $12,331   $18,716 
           
Commitments and contingencies (Note 8)          
           
Liabilities and Stockholders’ Equity          
Current liabilities:          
Accounts payable  $3,275   $2,759 
Accrued expenses   3,983    2,631 
Deferred revenue   795    - 
Lease liabilities, short-term   813    680 
Notes payable   632    175 
Warrant liabilities   1,149    129 
Total current liabilities   10,647    6,374 
Lease liabilities, long-term   228    346 
Total Liabilities   10,875    6,720 
           
Stockholders’ Equity          
Preferred stock ($0.0001 par value); 1,000,000 shares authorized; no shares  issued and outstanding as of  September 30, 2023 and December 31, 2022   -    - 
Common stock ($0.0001 par value); 80,000,000 shares authorized; 15,688,268 and 13,127,472 shares  issued and outstanding as of September 30, 2023 and December 31, 2022, respectively   2    1 
Additional paid-in capital   30,696    23,929 
Accumulated deficit   (29,242)   (11,934)
Total stockholders’ equity   1,456    11,996 
Total Liabilities and Stockholders’ Equity  $12,331   $18,716 

 

5

 

 

Spectral AI, Inc.
Unaudited Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)

 

   Three Months Ended
September 30,		   Nine Months Ended
September 30,		 
   2023   2022   2023   2022 
                 
Research and development revenue  $3,440   $7,038   $12,769   $19,272 
Cost of revenue   (1,968)   (3,811)   (7,325)   (10,943)
Gross profit   1,472    3,227    5,444    8,329 
                     
Operating costs and expenses:                    
General and administrative   5,638    3,478    15,499    9,207 
Total operating costs and expenses   5,638    3,478    15,499    9,207 
Operating loss   (4,166)   (251)   (10,055)   (878)
                     
Other income (expense):                    
Net interest income   42    2    128    1 
Change in fair value of warrant liability   1,069    22    1,004    50 
Foreign exchange transaction loss, net   (24)   (51)   (11)   (255)
Transaction costs   (7,604)   -    (8,342)   - 
Other expense   -    (17)   -    - 
Total other expense, net   (6,517)   (44)   (7,221)   (204)
                     
Loss before income taxes   (10,683)   (295)   (17,276)   (1,082)
Income tax benefit (provision)   54    (85)   (32)   (91)
Net loss  $(10,629)  $(380)  $(17,308)  $(1,173)
Net loss per share of common stock                    
Basic and Diluted  $(0.77)  $(0.03)  $(1.29)  $(0.09)
Weighted average common shares outstanding                    
Basic and Diluted   13,822,990    13,145,834    13,410,287    13,127,825 

 

6

 

 

Non-GAAP Financial Measures

 

We use Adjusted EBITDA as a non-GAAP metric when measuring performance, including when measuring current period results against prior periods’ Adjusted EBITDA. This non-GAAP financial measure should be considered in addition to results prepared in accordance with GAAP and should not be considered as a substitute for, or superior to, GAAP results. In addition, Adjusted EBITDA should not be construed as an indicator of our operating performance, liquidity or cash flows generated by operating, investing and financing activities, as there may be significant factors or trends that it fails to address.

 

Because of their non-standardized definitions, non-GAAP measures (unlike GAAP measures) may not be comparable to the calculation of similar measures of other companies. We caution investors that non-GAAP financial information, by its nature, departs from traditional accounting conventions. Supplemental non-GAAP measures are presented solely to permit investors to more fully understand how Spectral AI’s management assesses underlying performance.

 

Adjusted EBITDA

 

We define Adjusted EBITDA as net loss excluding income taxes, depreciation of property and equipment, interest income, stock compensation, transaction costs and any non-operating financial income and expense.

 

The following table presents our Adjusted EBITDA for the three and nine months ended September 30, 2023 and 2022:

 

   Three Months Ended
 September 30,		   Nine Months Ended
 September 30,		 
   2023   2022   2023   2022 
   (In thousands) 
Net loss  $(10,629)  $(380)  $(17,308)  $(1,173)
Adjust:                    
Depreciation expense   2    -    7    6 
Provision for income taxes   (54)   85    32    91 
Net interest income   (42)   (2)   (128)   (1)
EBITDA   (10,723)   (297)   (17,397)   (1,077)
Additional adjustments:                    
Stock-based compensation   279    247    975    874 
Change in fair value of warrant liability   (1,069)   (22)   (1,004)   (50)
Foreign exchange transaction gain   24    51    11    255 
Transaction costs   7,604    -    8,342    - 
Other income   -    17    -    - 
Adjusted EBITDA  $(3,885)  $(4)  $(9,073)  $2 

 

7

 

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Cover
Nov. 13, 2023
Document Type 8-K
Amendment Flag false
Document Period End Date Nov. 13, 2023
Entity File Number 001-40058
Entity Registrant Name SPECTRAL AI, INC.
Entity Central Index Key 0001833498
Entity Tax Identification Number 85-3987148
Entity Incorporation, State or Country Code DE
Entity Address, Address Line One 2515 McKinney Avenue
Entity Address, Address Line Two Suite 1000
Entity Address, City or Town Dallas
Entity Address, State or Province TX
Entity Address, Postal Zip Code 75201
City Area Code 972
Local Phone Number 499-4934
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Entity Emerging Growth Company true
Elected Not To Use the Extended Transition Period false
Common Stock, par value $0.0001 per share  
Title of 12(b) Security Common Stock, par value $0.0001 per share
Trading Symbol MDAI
Security Exchange Name NASDAQ
Redeemable Warrants, each whole warrant exercisable for one share of Common Stock, at an exercise price of $11.50 per share  
Title of 12(b) Security Redeemable Warrants, each whole warrant exercisable for one share of Common Stock, at an exercise price of $11.50 per share
Trading Symbol MDAIW
Security Exchange Name NASDAQ
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