UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(MARK ONE)
☒ QUARTERLY REPORT PURSUANT TO SECTION
13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended March 31, 2026
☐ TRANSITION REPORT PURSUANT TO SECTION
13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
Commission file number:
SPECTRAL AI, INC.
(Exact Name of Registrant as Specified in Its
Charter)
Delaware 85-3987148
(State or other jurisdiction of
incorporation or organization) (I.R.S. Employer
Identification No.)
2515 McKinney Avenue ,
Suite 1000
Dallas , Texas 75201
(Address of principal executive offices)
(972) 499-4934
(Issuer’s telephone number)
Securities registered pursuant to Section 12(b) of the Exchange Act:
Title of each class Trading Symbol(s) 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 $2.75 MDAIW The Nasdaq Stock Market LLC
Indicate by check mark whether the registrant
(1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12
months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements
for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant
has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405
of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes
☒ No ☐
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company.
See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and
“emerging growth company” in Rule 12b-2 of the Exchange Act.
Large Accelerated Filer ☐ Accelerated Filer ☐
Non-Accelerated Filer ☒ Smaller Reporting Company ☒
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. ☐
Indicate by check mark whether the registrant
is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As of May 11, 2026, there were 31,823,985 shares
of Common Stock, $0.0001 par value, issued and outstanding.
SPECTRAL AI, INC.
FORM 10-Q FOR THE QUARTER ENDED MARCH 31, 2026
TABLE OF CONTENTS
Page
Part I. Financial Information
1
Item 1. Interim Financial Statements
1
Unaudited Condensed Consolidated Balance Sheets as of March 31, 2026 and December 31, 2025
1
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the three months ended March 31, 2026 and 2025
2
Unaudited Condensed Consolidated Statements of Changes in Stockholders’ Deficit for the three months ended March 31, 2026 and 2025
3
Unaudited Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2026 and 2025
4
Notes to Unaudited Condensed Consolidated Financial Statements
5
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
19
Item
3. Quantitative and Qualitative Disclosures About Market Risk
30
Item
4. Controls and Procedures
30
Part II. Other Information
Item
1. Legal Proceedings
31
Item
1A. Risk Factors
31
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds
31
Item
3. Defaults Upon Senior Securities
31
Item
4. Mine Safety Disclosures
31
Item
5. Other Information
31
Item
6. Exhibits
31
Part
III. Signatures
32
i
PART I - FINANCIAL INFORMATION
Item 1. Interim Financial Statements
SPECTRAL AI, INC.
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
March 31,
December 31,
2026
2025
Assets
Current assets:
Cash
$ 11,655
$ 15,394
Accounts receivable, net
1,185
1,267
Inventory
831
838
Prepaid expenses
738
821
Other current assets
1,577
1,133
Total current assets
15,986
19,453
Non-current assets:
Property and equipment, net
228
258
Right-of-use assets
1,260
1,407
Other assets
260
287
Total Assets
$ 17,734
$ 21,405
Commitments and contingencies (Note 7)
Liabilities and Stockholders’ Equity (Deficit)
Current liabilities:
Accounts payable
$ 1,422
$ 3,010
Accrued expenses
2,649
2,341
Deferred revenue
-
154
Lease liabilities, short-term
755
734
Notes payable
3,912
2,854
Warrant liabilities
12,535
11,533
Total current liabilities
21,273
20,626
Notes payable, long-term
4,502
5,538
Lease liabilities, long-term
769
968
Total Liabilities
26,544
27,132
Stockholders’ Deficit
Preferred stock ($ 0.0001 par value); 1,000,000 shares authorized; no shares issued and outstanding as of March 31, 2026 and December 31, 2025, respectively
-
-
Common stock ($ 0.0001 par value); 80,000,000 shares authorized; 31,823,895 and 30,688,895 shares issued and outstanding as of March 31, 2026 and December 31, 2025, respectively
3
3
Additional paid-in capital
50,369
50,030
Accumulated other comprehensive income
30
40
Accumulated deficit
( 59,212 )
( 55,800 )
Total Stockholders’ Deficit
( 8,810 )
( 5,727 )
Total Liabilities and Stockholders’ Deficit
$ 17,734
$ 21,405
The accompanying notes
are an integral part of these condensed consolidated financial statements
1
SPECTRAL AI, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS
OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share data)
Three Months Ended
March 31,
2026
2025
Research and development revenue
$ 3,991
$ 6,707
Cost of revenue
( 1,964 )
( 3,539 )
Gross profit
2,027
3,168
Operating costs and expenses:
General and administrative
3,998
4,064
Total operating costs and expenses
3,998
4,064
Operating loss
( 1,971 )
( 896 )
Other income (expense):
Net interest (expense) income
( 258 )
( 20 )
Financing related costs
( 7 )
( 581 )
Amortization of debt discount
( 179 )
-
Change in fair value of warrant liability
( 1,002 )
4,253
Change in fair value of notes payable
( 220 )
Foreign exchange transaction loss, net
( 5 )
( 8 )
Total other income (expense), net
( 1,451 )
3,864
Income (loss) before income taxes
( 3,422 )
2,968
Income tax provision
10
( 71 )
Net income (loss)
$ ( 3,412 )
$ 2,897
Net income (loss) per share of common stock
Basic
$ ( 0.11 )
$ 0.13
Diluted
$ ( 0.11 )
$ 0.11
Weighted-average common shares outstanding
Basic
31,756,649
22,986,350
Diluted
31,756,649
24,030,518
Other comprehensive income (loss):
Foreign currency translation adjustments
$ ( 10 )
$ 17
Total comprehensive income (loss)
$ ( 3,422 )
$ 2,914
The accompanying notes
are an integral part of these condensed consolidated financial statements
2
SPECTRAL
AI, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS
OF CHANGES IN STOCKHOLDERS’ DEFICIT
(In thousands, except share data)
Accumulated
Common Stock
Additional
Paid-in
Other
Comprehensive
Accumulated
Total
Stockholders’
Shares
Amount
Capital
Income
Deficit
Deficit
Balance at December 31, 2025
30,688,895
$ 3
$ 50,030
$ 40
$ ( 55,800 )
$ ( 5,727 )
Stock-based compensation
-
-
183
-
-
183
Stock option exercises
150,000
-
156
-
-
156
Vesting of restricted stock units
50,000
-
-
-
-
-
Cumulative translation adjustment
-
-
-
( 10 )
-
( 10 )
Pre-funded warrant exercises
935,000
-
-
-
-
-
Net loss
-
-
-
-
( 3,412 )
( 3,412 )
Balance at March 31, 2026
31,823,895
3
50,369
30
( 59,212 )
( 8,810 )
Additional
Accumulated Other
Total
Common Stock
Paid-in
Comprehensive
Accumulated
Stockholders’
Shares
Amount
Capital
Income
Deficit
Deficit
Balance at December 31, 2024
22,594,877
$ 2
$ 40,973
$ 3
$ ( 48,229 )
$ ( 7,251 )
Stock-based compensation
-
-
200
-
-
200
Issuance of Common Stock from debt offering (net of $158K issuance costs)
2,028,846
-
377
-
-
377
Issuance of common stock to pay convertible debt
610,426
-
1,433
-
-
1,433
Sale of common stock (net of $19K issuance costs)
310,925
543
-
-
543
Exercise of stock options
43,047
158
-
-
158
Cumulative translation adjustment
-
-
-
17
-
17
Net income
-
-
-
-
2,897
2,897
Balance at March 31, 2025
25,588,121
$ 2
$ 43,684
$ 20
$ ( 45,332 )
$ ( 1,626 )
The accompanying notes
are an integral part of these condensed consolidated financial statements
3
SPECTRAL AI, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS
OF CASH FLOWS
(in thousands)
Three Months Ended
March 31,
2026
2025
Cash flows from operating activities:
Net income (loss)
$ ( 3,412 )
$ 2,897
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense
30
2
Amortization of debt issuance costs
179
-
Stock-based compensation
183
200
Amortization of right-of-use assets
147
141
Change in fair value of warrant liabilities
1,002
( 4,253 )
Change in fair value of notes payable
-
( 220 )
Issuances of shares for borrowing related costs
-
241
Changes in operating assets and liabilities:
Accounts receivable
82
402
Inventory
7
( 12 )
Prepaid expenses
110
2
Other assets
( 444 )
( 94 )
Accounts payable
( 1,588 )
( 947 )
Accrued expenses
308
502
Deferred revenue
( 154 )
( 297 )
Lease liabilities
( 178 )
( 69 )
Net cash used in operating activities
( 3,728 )
( 1,505 )
Cash flows from financing activities:
Proceeds from issuance of common stock and warrants
-
3,080
Proceeds from notes payable
-
8,285
Payments for notes payable
( 157 )
( 1,131 )
Stock option exercises
156
158
Net cash provided by financing activities
( 1 )
10,392
Effect of exchange rate changes on cash
( 10 )
17
Net increase in cash
( 3,739 )
8,904
Cash, beginning of period
15,394
5,157
Cash, end of period
$ 11,655
$ 14,061
Supplemental cash flow information:
Cash paid for interest
$ 278
$ 11
Cash paid for taxes
$ 5
$ 11
Noncash investing and financing activities disclosure:
Tenant improvement allowance payments made by the lessor directly to a third party
$ -
$ 164
Issuance of common stock to settle notes payable
$ -
$ 1,192
Capitalized and unpaid debt issuance costs
$ -
$ ( 25 )
The accompanying notes
are an integral part of these condensed consolidated financial statements
4
SPECTRAL AI, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
1. NATURE OF THE BUSINESS AND PRESENTATION
Overview
Spectral AI, Inc., a Delaware
corporation (the “Company”) is an Artificial Intelligence (“AI”) company focused on predictive medical diagnostics.
Our DeepView ® System uses proprietary AI algorithms to distinguish between healthy, partially damaged and fully damaged
human tissue characteristics invisible to the naked eye, at the initial time of wound presentation. The DeepView System delivers a binary
prediction on the wound’s capacity to heal or not-heal by a specified time in the future. Our DeepView System’s output is
specifically engineered to assist the physician in making a more accurate, timely and informed diagnostic decision regarding the treatment
of the patient’s wounds. Our focus is on our burn indication.
In February 2024, our DeepView
System, comprised of the multispectral imaging (“MSI”) component integrated with the predictive AI-Burn ® software
component, received United Kingdom Conformity Assessed (“UKCA”) marking for use in the United Kingdom for burn indications.
In June 2025, we filed a De Novo application for the DeepView System with the United States Food and Drug Administration (“FDA”)
so that it may achieve Class II medical device designation. Following our anticipated receipt of additional necessary commercial market
authorization, our business will have two primary revenue streams, a SaaS (software as a service) offering aligned with SaMD (software
as a medical device) regulatory framework, and the imaging device component. The SaaS component will feature a software licensing fee
that includes maintenance, image hosting, and access to algorithmic updates. The proprietary imaging device acquires the images for the
AI algorithms and is a universal platform to house multiple clinical indications including burn wound healing analysis and other tissue
indication assessments. Pricing for these components will be evaluated and strategically set per country and site-of-service for
heightened customer adoption.
The DeepView System is comprised
of the DeepView-AI Burns ® software and the DeepView SnapShot ® imaging device, and it is intended to be
used as an adjunctive tool to aid health care providers in the assessment of burn wound healing potential by differentiating non-healing
from healing tissue within an image. The MSI imaging technology within the DeepView SnapShot imaging device consists of patented proprietary
multi-spectral optics and sensors, capturing injured tissue images ranging from near ultraviolet light, through the human visible wavelengths,
and into the near infrared range. The broad wavelength ranges go beyond what the human eyes can see and capture what medical professionals
cannot observe with their naked eyes. This wide range of wavelength images contains wound tissue physiology and captures the viability
of various biomarkers within the skin and from the injured tissue spectral signatures. The imaging technology extracts appropriate clinical
data and processes the image data to provide the injured tissue spectral signatures to the DeepView AI Burns software AI model and algorithms.
The AI algorithm classifies various severities of the injuries as (i) fully damaged (non-healing), (ii) partially damaged or
(iii) healthy tissue (healing) and displays a comparison of the original image next to an image with a color overlay of the non-healing
portions of the wound. The image acquisition takes 0.2 seconds, and all image processing and AI model classification takes approximately
20 to 25 seconds. Our DeepView System’s proprietary optics can extract millions of pixels of data or AI model features from each
group of raw images. This information is then used to advance algorithm optimization, which is trained and tested against a proprietary
and clinically validated database of over 340 billion pixels of image data as of December, 2024.
The Company has not generated
any product revenue to date. The Company currently generates revenue from contract development and research services by providing such
services to governmental agencies, primarily to the Biomedical Advanced Research and Development Authority (“BARDA”) and
under a contract with the Medical Technology Enterprise Consortium (“MTEC”).
5
We have received substantial
support from the U.S. government for our DeepView System’s application for burn wounds from BARDA, which is part of the Department
of Health and Human Services Office of the Assistant Secretary for Preparedness and Response in the United States, established to
aid in securing the United States from chemical, biological, radiological, and nuclear threats, as well as from pandemic influenza
and emerging infectious diseases. We have also received funding from the National Science Foundation, the National Institute of Health
and the Defense Health Agency (“DHA”), an agency within the Department of Defense. On September 27, 2023, the Company
executed a new contract with BARDA, providing the Company with additional funding of up to approximately $ 150.0 million. This includes
an initial award of approximately $ 54.9 million to support the clinical validation study and the distribution of up to 30 DeepView
Systems in various burn centers and emergency departments to support the study and approximately another $ 95.0 million for further follow-on
development and procurement activities related to the DeepView System. The funding also supported the Company’s FDA De Novo submission
of our DeepView AI – Burn software, which was completed on June 30, 2025. In March 2026, BARDA exercised a portion of its contractual
options under the contract, providing the Company with (i) a no-cost extension of the base phase of the contract from March, 2026 to
June 2026 and (ii) accelerated funding of approximately $31.7 million for further follow-on development and procurement activities related
to the DeepView System . The contract continues to provide additional options, similar to our prior BARDA contracts, with an additional
$ 63.4 million which can be exercised for additional product development, and the expanded procurement and deployment of DeepView
Systems at emergency rooms, trauma and burn centers. These deployments will enable the Company to conduct health economic and outcome
research studies to support the broader clinical adoption of the DeepView System. As part of this funding advance, the Company has committed
to fund $ 9.7 million of the total overall development costs associated with these feature advancements.
Subject to our receipt of
the necessary regulatory market authorizations, we intend to initially sell the DeepView System throughout the United States and
the UK for its burn indication. Given our receipt of the UKCA authorization for our burn indication we anticipate initial sales in UK
to begin in 2026 with an expanded labeling in the UK to include the FDA submitted DeepView System algorithm and features. The sales channel
for our burn indication will be supported by existing and future governmental contracts, primarily from agencies such as BARDA and the
DHA. In the United States, there are approximately 100 burn centers, 700 trauma centers and 5,400 federal and community hospitals
with emergency rooms where the burn patients are most likely to present upon injury. The DeepView System provides a quick clinical diagnostic
decision tool for emergency room clinicians. It can be used to quickly assess the healing potential for burn wounds so decisions regarding
whether patients need routine care or should be transferred to trauma centers or burn centers for advanced care and accurate surgical
planning can be made in a much more timely fashion. The DeepView System provides an advanced diagnostic assessment of the non-healing
areas of a burn in emergency rooms, trauma centers and burn centers. For the DeepView System’s burn application and following receipt
of any future contract awards, we plan to partner with the U.S. governmental agency sponsors to implement the distribution of our
DeepView System throughout the United States into key regions to support the United States’ mass casualty countermeasure directives,
with the goal of making our country better prepared for mass casualty events and saving scarce healthcare resources.
6
Basis of Presentation
The Company’s condensed
consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“GAAP”)
as determined by the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”)
or an Accounting Standards Update (“ASU”).
These condensed consolidated
financial statements should be read in conjunction with the financial statements and notes included in the Company’s audited consolidated
financial statements as of and for the years ended December 31, 2025 and 2024. The condensed consolidated balance sheet as of December
31, 2025 included herein was derived from the audited consolidated financial statements as of that date.
The accompanying unaudited
condensed consolidated financial statements reflect all normal recurring adjustments necessary to present fairly the financial position,
results of operations, and cash flows for the interim periods. The results for the three months ended March 31, 2026 are not necessarily
indicative of the results to be expected for any subsequent quarter, the year ending December 31, 2026, or any other period.
Except as described elsewhere
in Note 2 under the heading “Recently accounting pronouncements,” there have been no material changes to the Company’s
significant accounting policies as described in the audited consolidated financial statements as of December 31, 2025.
Principles of Consolidation
The condensed consolidated
financial statements include the accounts of the Company and its wholly-owned subsidiaries, Spectral MD Holdings LLC, Spectral MD, Inc.,
Spectral MD UK Limited (“Spectral MD UK”), and Spectral IP, Inc. (“Spectral IP”). Inter-company transactions
and balances have been eliminated in consolidation.
Use of Estimates
The preparation of the condensed
consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts
reported in the condensed consolidated financial statements and accompanying notes. The Company bases its estimates and judgments on
historical experience and on various other assumptions that it believes are reasonable under the circumstances. The amounts of assets
and liabilities reported in the Company’s balance sheets and the amounts of expenses reported for each of the periods presented
are affected by estimates and assumptions, which are used for, but not limited to, revenue recognition (including the measure of progress
of completion), warrant liabilities, the fair value of certain debt, stock-based compensation expense, stock issued for transaction costs,
the net realizable value of inventory, right-of-use assets, and income tax valuation allowances. Actual results could differ from these
estimates.
Segments
Operating segments are defined
as components of an enterprise for which separate and discrete information is available for evaluation by the chief operating decision-maker
in deciding how to allocate resources and assess performance. The Chairman of the Board in conjunction with the Company’s executive
management team manages the Company’s operations on an aggregate basis for the purpose of allocating resources.
The Company has one operating
segment. The accounting policies of the Company’s single operating and reportable segment are the same as those described in the
summary of significant accounting policies.
7
The Company’s method
for measuring profitability includes net loss, which the chief operating decision-maker uses to assess performance and make decisions
for resource allocation, consistent with the measurement principals for net income(loss) as reported on the Company’s consolidated
statement of operations. The significant expenses regularly reviewed by the chief operating decision-maker are consistent with those
reported on the Company’s consolidated statement of operations as well as research and development expenses which are disclosed
in the footnotes to these financial statements. Certain expenses are reviewed for purposes of assessing operating activities and resource
allocation for the Company. The measure of segment assets is reported on the consolidated balance sheets as total assets.
Income Taxes
The
Company recorded an income tax provision for Texas Franchise Tax of approximately $ 10,000 during the three-month period ended March 31,
2026. The Company recorded an income tax provision of approximately $ 71,000 three month period ended March 31, 2025. The effective tax
rate was ( 0.3 )% for the three-month period ended March 31, 2026, and 2.4 % for the three-month period ended March 31, 2025.
The
tax provision for interim periods is determined using an estimate of the Company’s annual effective tax rate, adjusted for discrete
items arising in that quarter. The Company’s effective tax rate differs from the U.S. statutory tax rate in the three months ended
March 31, 2026, primarily due to changes in valuation allowances on deferred tax assets as it is more likely than not that the Company’s
deferred tax assets will not be realized.
The
Company evaluates its tax positions on a quarterly basis and revises its estimate accordingly.
Concentrations of Credit Risk
Financial instruments which
potentially subject the Company to credit risk consist principally of cash and accounts receivable. Primarily all cash is held in US
financial institutions which, at times, exceed federally insured limits. The Company has not recognized any losses from credit risks
on such accounts. The Company believes it is not exposed to significant credit risk on cash.
Additional credit risk is
related to the Company’s concentration of accounts receivable. As of March 31, 2026 and December 31, 2025, accounts receivable
were concentrated from one customer (which is a US. government agency) representing 100 % in each period. No allowance for expected credit losses was recorded as of March 31, 2026 and December 31, 2025.
One customer (which is a
U.S. government agency) accounted for 83 % for the three months ended March 31, 2026 and 95 % for the three months ended March
31, 2025 of the recognized research and development revenue.
8
Risks and Uncertainties
The Company is subject to
a number of risks common to development stage companies in the medical technology industry, including, but not limited to, risks of failure
of preclinical studies and clinical trials, dependence on key personnel, protection of proprietary technology, reliance on third party
organizations, risks of obtaining regulatory approval for any products that it may develop, development by competitors of technological
innovations, compliance with government regulations and the need to obtain additional financing.
Liquidity
As
of March 31, 2026 and December 31, 2025, the Company had approximately $ 11.7 million and $ 15.4 million, respectively, in cash, and an
accumulated deficit of $ 59.2 million and $ 55.8 million, respectively. As of March 31, 2026 and December 31, 2025, the Company had approximately
$ 8.4 million and $ 8.4 million, respectively, of debt outstanding of which $ 4.5 million and $ 5.5 million represented long-term debt as
of such periods.
On March 24, 2025, the Company
completed an equity financing and entered into a long-term debt financing agreement with Avenue Venture Opportunities Fund II, L.P.,
a fund of Avenue Capital Group (the “Avenue Financing”), which provides for the ability to borrow up to $ 15.0 million with
an initial draw-down of $ 8.5 million, and the remaining availability is contingent upon, among other things, FDA clearance of the DeepView
System, see Note 6.
The Avenue Financing also included warrant coverage equal to 8.5 % of the total funding commitment from Avenue, with an exercise price
equal to the lower of (i) average of the daily volume weighted average price of Common Stock as reported for each of five (5) consecutive
trading days , determined as of the end of the trading on the last trading day before the date of issuance, which was $ 1.66 and (ii) the
lowest price per share paid to the Company by cash investors for Common Stock issued in any sale of Common Stock in a bona-fide equity
raising that closes at any time commencing from March 21, 2025 through (but excluding) December 31, 2025.
On March 21, 2025, as a condition to the Avenue Financing, the Company entered into securities purchase agreements with certain investors
in the United States and the United Kingdom for the sale of an aggregate of 2,076,923 shares of the Company’s Common Stock, at an
offering price of $ 1.30 per Share which raised an additional $ 2.7 million.
On October 22, 2025, the
Company entered into a securities purchase agreement with Hudson Bay Master Fund Ltd., which provided for the issuance and sale of 3.1
million shares of Common Stock, at an offering price of $ 1.90 per share. In addition, in a concurrent private placement, the Company
issued and sold warrants for the purchase of up to 4.0 million shares of Common Stock and pre-funded warrants to purchase up to 0.9 million
shares of common stock, for aggregate gross proceeds of $ 7.6 million (such transaction, the “Hudson Bay Financing”). Each
warrant has an exercise price per share of $ 2.51 and will be exercisable on the earlier of (a) the effective date of stockholder approval
for the issuance of shares of Common Stock underlying the warrants and (b) the date that is six months following the issuance date of
the warrants and will have a term of five (5) years from the initial issuance date. See Note 2 for further information.
On March 18, 2026, the Company
announced that it has received a contract modification from BARDA for the acceleration of $ 31.7 million from its existing contract
with BARDA which included (i) a no-cost extension of the base phase of the contract, and (ii) the acceleration of certain parts of the
next phase of such contract. As part of this funding advance, the Company has committed to fund $ 9.7 million of the total
overall development costs associated with these feature advancements. This funding comes as part of an ongoing partnership with
BARDA, which has committed $ 86.6 million to date under the contract with an overall value of approximately $ 150 million.
As
of March 31, 2026, based on our current operating plan, we believe that our cash and cash equivalents, together with the PBS BARDA
Contract, the MTEC Agreement, the Avenue Financing, the Hudson Bay Financing, the Yorkville SEPA and certain research and
development cost-saving measures, the Company believes it has, sufficient working capital to fund operations for at least one year
beyond the release date of the condensed consolidated financial statements. We have based this determination on assumptions that may
prove to be wrong, and we could utilize our available capital resources sooner than we currently expect. Changing circumstances
could also cause us to consume capital significantly faster than we currently anticipate, and we may need to raise capital sooner or
in greater amounts than currently expected because of circumstances beyond our control. To the extent additional capital is
necessary, there are no assurances that we will be able to raise additional capital on favorable terms or at all, and therefore we
may not be able to execute our business plans and the continued work on indications beyond expanding our burn indication.
9
2. RECENT ACCOUNTING PRONOUCEMENTS
Recently Adopted Accounting Standards
In
July 2025, the FASB issued ASU No. 2025-05, Measurement of Credit Losses for Accounts Receivable and Contract Assets, (“ASU 2025-05”)
which provides a practical expedient to measure credit losses on accounts receivable and contract assets. The Company adopted this guidance
prospectively in the three months ended March 31, 2026. The adoption of ASU 2025-05 did not have a material impact on the consolidated
financial statements and related disclosures.
Recently Issued Accounting Standards
In October 2023, the
FASB issued ASU 2023-06 Disclosure Improvements: Codification Amendments in Response to the SEC’s Disclosure Update and Simplification
Initiative (“ASU 2023-06”), which modifies certain disclosure and presentation requirements of a variety of Topics in the
Codification and is intended to both clarify or improve such requirements and align the requirements with the SEC’s regulations.
The effective date for each amendment is the effective date of the removal of the related disclosure from Regulation S-X or Regulation
S-K, with early adoption prohibited. The Company will apply the provisions prospectively as such provisions become effective and does
not expect ASU 2023-06 to have a material impact on the consolidated financial statements.
In November 2024, the FASB
issued ASU No. 2024-03, Income Statement- Reporting Comprehensive Income- Expense Disaggregation Disclosures (Subtopic 220-40),
requiring public business entities to disclose additional information about specific expense categories in the notes to financial statements
at interim and annual reporting periods. ASU 2024-03 is effective for fiscal years beginning after December 15, 2026, and interim
reporting periods beginning after December 15, 2027, with early adoption permitted. The disclosures required under the guidance can be
applied either prospectively to financial statements issued for reporting periods after the effective date or retrospectively to any
or all periods presented in the financial statements. The Company is currently evaluating the impact of adopting this guidance on its
consolidated financial statements and disclosures.
3. FAIR VALUE MEASUREMENTS
The following table presents
information about the Company’s financial liabilities that are measured at fair value on a recurring basis as of March 31, 2026
and December 31, 2025, by level within the fair value hierarchy (in thousands):
Fair value measured as of March 31, 2026
Fair
Quoted
prices
Significant
other
Significant
value at
March 31, 2026
in active
markets
(Level 1)
observable
inputs
(Level 2)
unobservable
inputs
(Level 3)
Warrant liabilities
$ 12,535
$ 4,723
$ -
$ 7,812
$ 12,535
$ 4,723
$ -
$ 7,812
Fair value measured as of December 31, 2025
Fair
Quoted
prices
Significant
other
Significant
value at
December 31,
2025
in active
markets
(Level 1)
observable
inputs
(Level 2)
unobservable
inputs
(Level 3)
Warrant liabilities
$ 11,533
$ 3,795
$ -
$ 7,738
$ 11,533
$ 3,795
$ -
$ 7,738
10
There were no transfers
between Level 1, 2 or 3 during the three months ended March 31, 2026.
Fair values of cash, accounts
receivable, accounts payable, accrued expenses, and short-term debt are carried at cost, which management believes approximates fair
value due to the short-term nature of these instruments. The fair value of the Public Warrants, which trade in active markets, is based
on quoted market prices and classified in Level 1 of the fair value hierarchy. The Angel Warrants, Avenue Warrants, Investor Warrants,
and Hudson Warrants are classified within Level 3 of the fair value hierarchy because their fair values are based on significant inputs
that are unobservable in the market.
The fair value of
the Angel Warrants and Avenue Warrants at March 31, 2026 were estimated using a Black-Scholes option pricing model. The fair value of
the Investor Warrants and Hudson Warrants were estimated using a simulation model.
The following table presents
changes in Level 3 liabilities measured at fair value for the three months ended March 31, 2026 and 2025 (in thousands):
Balance - January 1, 2026
$ 7,738
Change in fair value
74
Balance - March 31, 2026
$ 7,812
Balance - January 1, 2025
$ 41
Issuance
2,908
Change in fair value
( 37 )
Balance - March 31, 2025
$ 2,912
Both observable and unobservable
inputs were used to determine the fair value of warrants that the Company has classified within the Level 3 category. Unrealized gains
and losses associated with liabilities within the Level 3 category include changes in fair value that were attributable to both observable
(e.g., changes in market interest rates) and unobservable (e.g., changes in unobservable long-dated volatilities) inputs.
The following table provides
quantitative information regarding Level 3 fair value measurements inputs at their measurement:
March 31, 2026
Angel
Warrants
Investor
Warrants
Avenue
Warrants
Hudson
Warrants
Valuation Method
Black Scholes
Monte Carlo
Black Scholes
Monte Carlo
Strike price (per share)
$ 7.32
$ 1.80
$ 1.66
$ 2.51
Contractual term (years)
1.2
4.0
3.3
4.6
Volatility (annual)
93.1 %
80.0 %
78.1 %
80.0 %
Risk-free rate
3.7 %
3.8 %
3.8 %
3.9 %
Dividend yield (per share)
0.0 %
0.0 %
0.0 %
0.0 %
Probability assessment (1)
n/a
10 %- 30 %
n/a
10 %- 30 %
December 31, 2025
Angel
Warrants
Investor
Warrants
Avenue
Warrants
Hudson
Warrants
Valuation Method
Black Scholes
Monte Carlo
Black Scholes
Monte Carlo
Strike price (per share)
$ 7.32
$ 1.80
$ 1.66
$ 2.51
Contractual term (years)
1.5
4.2
3.5
4.8
Volatility (annual)
92.1 %
80.0 %
79.0 %
70.0 %
Risk-free rate
3.5 %
3.6 %
3.6 %
3.6 %
Dividend yield (per share)
0.0 %
0.0 %
0.0 %
0.0 %
Probability assessment (1)
n/a
10 %- 30 %
n/a
10 %- 30 %
(1) Probability assessment reflects management’s estimate of the likelihood of an event that could accelerate exercisability or modify
settlement mechanics under the warrant agreements
11
Warrant Liabilities
On
September 11, 2023, in conjunction with the Business Combination, the Company assumed the Public Warrants which had an exercise price
of $ 11.50 per share, are exercisable 30 days after the Business Combination and expire five years after the Business Combination or upon
redemption. The Company may redeem the Public Warrants if the Company’s common stock, $ 0.0001 par value (“Common Stock”)
equals or exceeds $ 18.00 per share for 20 trading days within a 30 -trading day period ending on the third trading day prior to the date
on which the Company sends the notice of redemption to the holders of Public Warrants. In November 2024, the Company amended the Public
Warrants to have an exercise price of $ 2.75 per share. As of March 31, 2026, there are 8,433,333 Public Warrants outstanding. Each warrant
entitles the registered holder to purchase one share of Common Stock at an exercise price of $ 2.75 per full share. Pursuant to the Warrant
Agreement, a holder of Public Warrants may exercise its Public Warrants only for a whole number of shares of Common Stock. This means
that only a whole warrant may be exercised at any given time by a holder of Public Warrants. The Company maintains a redemption right
with respect to the Public Warrants in that the Company can redeem some or all of the Public Warrants for $ 0.10 per Public Warrant based
on certain market conditions and the market price of the Company Common Stock.
In
September 2021, the Company issued 73,978 warrants, with a strike price of $ 7.32 and a five-year life, to SP Angel Corporate
Finance LLP (“SP Angel”), who acted as nominated adviser and broker to the Company for the purposes of the AIM Rules relating
to the London Stock Market (the “Angel Warrants”). In conjunction with the Business Combination, the Angel Warrants were
converted into warrants to purchase Common Stock based on the exchange ratio as set forth in the Business Combination agreements. As
of March 31, 2026, there are 77,017 Angel Warrants to purchase Common Stock outstanding. In December 2025, SP Angel was issued 3,039
additional Angel Warrants due to an anti-dilution right that was implicated in a Qualifying Financing (as defined in the warrant agreement).
The Hudson Bay transaction, which closed in October 2025, qualified as a Qualifying Financing. Following the adjustment, there were 77,017
Angel Warrants Outstanding.
Investor
Warrants: On March 21, 2025, the Company entered into the purchase agreements with certain stockholders for the sale of an aggregate
of 2,068,846 shares of Common Stock, at an offering price of $ 1.30 per Share (the “Purchase Agreements”). In a concurrent
private placement pursuant to the Purchase Agreements (the “Private Placement”), the Company agreed to sell to the investors
an aggregate of 2,068,846 warrants to purchase shares of Common Stock at an exercise price of $ 1.80 per share (the “Investor Warrants”).
The Investor Warrants, along with the shares of Common Stock issuable upon the exercise of the Investor Warrants, were offered pursuant
to the exemptions provided in Section 4(a)(2) under the Securities Act of 1933, as amended (the “Securities Act”). No
consideration was received by the Company for the issuance of the Investor Warrants.
The
Investor Warrants issued in connection with the Purchase Agreements are exercisable any time on or after March 20, 2025 (the “Issuance
Date”) and on or prior to the close of business on the third anniversary of the Issuance Date. Additionally, the Investor Warrants
issued in connection with the Purchase Agreements contain adjustment provisions in the event of (i) stock dividends and split, (ii) reclassifications
of securities, (iii) issuance of Common Stock or Common Stock Equivalents (as defined in the Purchase Agreements), (iv) pro rata distributions,
(v) Fundamental Transactions (as defined in the Warrants), and (vi) subsequent equity sales of shares of common stock or common stock
equivalents for a consideration per share less than a price equal to $ 1.30 , subject to a floor of $ 0.65 per share. The Investor Warrants
issued in connection with the Purchase Agreements also include a “Most Favored Nation” clause which grants the holders of
such Investor Warrants the right, in their sole discretion, to elect to receive more favorable terms and conditions given to a subsequent
investor in a subsequent financing transaction (including, but not limited to, a lower purchase price per share, a higher warrant coverage
percentage, a lower warrant exercise price, a longer warrant exercise period, more favorable anti-dilution protections, preferential
liquidation rights, enhanced voting rights, reduced fees or commissions, more advantageous registration rights, or the inclusion of additional
incentives such as cash bonuses, dividend preferences, or equity sweeteners). The Investor Warrants were determined to be liability
classified instruments, as certain terms preclude them from being considered indexed to the Company’s Common Stock. The gross proceeds
of the Private Placement and Investor Warrants of $ 2.7 million were allocated to the Investor Warrants based on their fair value at issuance
of $ 2.2 million, with the residual gross proceeds of $ 0.5 million allocated to the Common Stock. Total issuance costs incurred of $ 0.2
million were allocated between the Investor Warrants and Common Stock issued. Issuance costs allocated to the Investor Warrants of $ 43,000
were expensed during the year ended December 31, 2025 as financing related costs in the consolidated statement of operations and comprehensive
loss. Issuance costs allocated to the Common Stock of $ 152,000 were recorded in additional paid-in-capital.
12
In
May 2025, 915,000 Investor Warrants (the “Amended Investor Warrants”) were amended and restated. The amendment extended the
contractual term such that the Amended Investor Warrants are exercisable any time on or prior to the close of business on the fifth anniversary
of the Issuance Date and resulted in $ 137,000 increase in the fair value of the warrants recognized as additional expense in the change
in fair value of warrant liabilities in the consolidated statement of operations and comprehensive loss.
During
the year ended December 31, 2025, 1,403,846 Investor Warrants were exercised. The warrants were remeasured to fair value immediately
prior to exercise and the carrying amount of the warrant liability was derecognized and reclassified to additional paid-in-capital. Any
proceeds received from exercise were recognized in stockholders’ equity. The exercise of warrants resulted in an increase to stockholders’
equity of $ 4.7 million. For the three months ended March 31, 2026 no Investor Warrants were exercised. As of March 31, 2026, there were
665,000 Investor Warrants to purchase Common Stock outstanding.
Avenue Warrants:
On March 24, 2025, the Company completed the Avenue Financing, with an initial draw-down of $ 8.5 million. As part of the Avenue Financing,
the Company issued 768,072 warrants to Avenue Capital Group which was equal to 8.5 % of the total funding commitment (the “Avenue
Warrants”). The Avenue Warrants have an exercise price equal to the lower of $ 1.66 per share and the lowest price per share paid
to the Company in cash for common stock through December 31, 2025. The Avenue Warrants were determined to be classified as a liability
instrument as certain terms preclude them from being considered indexed to the Company’s Common Stock.
The net proceeds of the
Avenue Financing of $ 8.3 million were first allocated to the fair value of the Avenue Warrants, with the residual proceeds being allocated
to the debt. The difference between debt proceeds and the amount of those proceeds allocated to debt gave rise to a debt discount of
$ 0.7 million. The discount amount due to the Avenue Warrants of $ 0.7 million along with the loan fees allocated to the loan of $ 1.0 million,
which includes the final payment of $ 0.8 million, for an aggregate debt discount and debt issuance costs of $ 1.7 million, will be amortized
as interest expense through maturity using the effective interest method. The portion of loan fees allocated to the Avenue Warrants,
of $ 22,000 , were expensed during the year ended December 31, 2025 as financing related costs in the consolidated statement of operations
and comprehensive loss.
As
of March 31, 2026, there were 768,072 Avenue Warrants to purchase Common Stock outstanding.
Hudson
Warrants: On October 22, 2025, the Company entered into a securities purchase agreement with a certain investor for the sale of 3,065,000
shares of Common Stock, at an offering price of $ 1.90 per Share (the “Offering”). In a concurrent private placement pursuant
to the purchase agreement, the Company agreed to sell to the investor (i) warrants (the “Hudson Warrants”) to purchase up
to 4,000,000 shares of Common Stock, and (ii) pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to 935,000 shares
of Common Stock. Each Hudson Warrant has an exercise price per share of $ 2.51 , will exercisable on the earlier of (a) the effective date
of stockholder approval for the issuance of shares of Common Stock underlying the warrants and (b) the date that is six months following
the issuance date of the warrants and will have a term of five years from the initial issuance date. Each Pre-Funded Warrant has a purchase
price of $1.8999 , an exercise price per share of $0.0001 , is exercisable immediately and may be exercised at any time until such Pre-Funded
Warrant is exercised in full. The Hudson Warrants and the Pre-Funded Warrants, along with the shares of Common Stock issuable upon the
exercise of the warrants, are being offered pursuant to the exemptions provided in Section 4(a)(2) under the Securities Act of 1933,
as amended.
13
The
Hudson Warrants and Pre-Funded Warrants contain adjustment provisions in the event of (i) stock dividends and split, (ii) pro rata distributions,
and (iii) Fundamental Transactions (as defined in the warrant agreements). In the event of a Fundamental Transaction not in the Company’s
control, the holders of the Warrants have the right to require the Company or a successor entity to redeem the Hudson Warrants for cash
in the amount of the Black Scholes Value (as defined in the warrant agreements). The Hudson Warrants contain further adjustment provisions
in the event of the (i) subsequent equity sales of shares of common stock or common stock equivalents for a consideration per share less
than a price equal to $ 2.51 (ii) changes in the exercise price or rate of conversion of equity sales or convertible securities any time
prior to the two-year anniversary of the stockholder approval date, subject to a floor of $ 0.48 per share. The Hudson Warrants were determined
to be liability classified instruments, as certain terms preclude them from being considered indexed to the Company’s Common Stock.
The Pre-Funded Warrants were determined to be equity classified instruments, as they are considered indexed to the Company’s stock
and do not contain any provisions that preclude equity classification. The gross proceeds of the Offering and private placement of $ 7.6
million were allocated to the Hudson Warrants based on their fair value at issuance of $ 7.5 million, with the residual gross proceeds
of $ 0.1 million allocated between the Common Stock and Pre-Funded Warrants based on their relative fair value. Total issuance costs of
$ 0.6 million were incurred and allocated between the warrants and Common Stock issued. Issuance costs allocated to the Hudson Warrants
of $ 0.6 million were expensed during the year ended December 31, 2025 as financing related costs in the consolidated statement of operations
and comprehensive loss. Issuance costs allocated to the Common Stock and Pre-Funded Warrants of less than $0.1 million were recorded
in additional paid-in-capital.
As
of March 31, 2026, there were 4,000,000 Hudson Warrants to purchase Common Stock outstanding.
The
Company accounts for its Public Warrants, Angel Warrants, Investor Warrants and Hudson Warrants as derivative liabilities. Accordingly,
the Company recognizes the instruments as liabilities at fair value, and adjusts the instruments to fair value at the end of each reporting
period. The liabilities are subject to re-measurement at each balance sheet date until exercised, redeemed or expired, and any change
in fair value is recognized in the Company’s consolidated statements of operations within other income (expense).
4. RESEARCH AND DEVELOPMENT REVENUE
For the three months ended
March 31, 2026 and 2025, the Company’s revenues disaggregated by the major sources were as follows (in thousands):
Three Months Ended
March 31,
2026
2025
BARDA
$ 3,311
$ 6,382
Other U.S. governmental authorities
680
325
Total revenue
$ 3,991
$ 6,707
The following table
presents the activity in the Company’s contract liabilities during the three months ended March 31, 2026:
December 31,
2025
Balance
Additions
Reductions
March 31,
2026
Balance
(in thousands)
Contract liabilities:
Deferred revenue
$ 154
$ 5,104
$ ( 5,258 )
$ -
Total contract liabilities
$ 154
$ 5,104
$ ( 5,258 )
$ -
14
The following table
presents the activity in the Company’s contract assets during the three months ended March 31, 2026:
December 31,
2025
Balance
Additions
Reductions
March 31, 2026
Balance
(in thousands)
Contract assets:
Unbilled revenue
$ 849
$ 447
$ -
$ 1,296
Total contract assets
$ 849
$ 447
$ -
$ 1,296
Research and Development Revenue
On March 18, 2026, the Company
announced that it has received a contract modification from the Biomedical Advanced Research and Development Authority (BARDA) for the
advancement of $ 31.7 million from its existing contract with BARDA which included (i) a no-cost extension of the base phase of the contract,
and (ii) the acceleration of certain parts of the next phase of such contract. As part of this funding advance, the Company has committed
to fund $ 9.7 million of the total overall development costs associated with these feature advancements. This funding comes as part of
an ongoing partnership with BARDA, which has committed $ 86.6 million to date under the contract with an overall value of approximately
$ 150 million.
Research and Development Expense
The Company expenses research
and development costs as incurred. These expenses include salaries for research and development personnel, consulting fees, product development,
pre-clinical studies, clinical trial costs, and other fees and costs related to the development of our technology. For the three months
ended March 31, 2026 and 2025, research and development expense was $ 2.0 million and $ 3.6 million, respectively, of which $ 2.0 million
and $ 3.4 million, respectively, is related to the combined BARDA contract and contracts with other U.S. governmental authorities
and included in cost of revenue and $ 64 thousand and $ 0.2 million, respectively, is included in general and administrative expenses.
5. ACCRUED EXPENSES
Accrued expenses consist
of the following as of March 31, 2026 and December 31, 2025 (in thousands):
March 31,
December 31,
2026
2025
Salary and wages
$ 2,017
$ 1,762
Operating expenses
74
81
Benefits
402
340
Non-operating expenses
96
98
Taxes
60
60
Total accrued expenses
$ 2,649
$ 2,341
15
6. NOTES PAYABLE
The Company entered into
the Avenue Financing and financing arrangements for a portion of its Directors and Officers (“D&O”) insurance premiums,
as follows (in thousands):
Principal Repayments
Outstanding Balance
Amount
Three Months Ended
March 31,
March 31
December 31,
Financed
Interest Rate
2026
2025
2026
2025
Avenue Capital Note Principal and Final Payment Fee
$ 8,500
Prime + 5.25 %
$ -
$ -
$ 9,250
$ 9,250
Yorkville Convertible Notes, at fair value
11,500
0.0 %
-
2,365
-
-
2025 Insurance Note
580
8.0 %
157
-
269
426
2024 Insurance Note
596
8.4 %
-
178
-
-
$ 157
$ 2,543
$ 9,519
$ 9,676
Less: current portion of notes payable
( 3,912 )
( 2,854 )
Unamortized debt discounts and debt issuance costs
( 1,105 )
( 1,284 )
Notes payable. long term
$ 4,502
$ 5,538
Avenue Capital Financing
On March 24, 2025, the Company
completed the Avenue Financing, with an initial draw-down of $ 8.5 million.
The term of the Avenue Financing
is for three years, with an interest-only payment period of no less than 15 months, which can be extended to 24 months upon achieving
the milestones for the second financing tranche. The second financing tranche, which includes an additional $ 6.5 million in debt financing
from Avenue Capital Group is contingent upon; (i) FDA clearance of the DeepView System and (ii) the Company completing a $ 7.0 million
equity raise. The borrowings under the Avenue Financing accrue interest at a variable amount per annum equal to the greater of (i) the
sum of (A) the Prime Rate plus (B) 5.25 %, and (ii) 12.75 %, and they mature on March 1, 2028 (the “Maturity Date”). In addition,
on the Maturity Date a final payment of $ 0.8 million is due to Avenue Capital Group and is accrued as debt as of March 31, 2026.
Up to $ 2.0 million of the
borrowings under the Avenue Financing are convertible at the lender’s option, into a number of shares of common stock at a price
per share equal to 120 % of the exercise price of the Avenue Warrants discussed below. Pursuant to the guidance in ASC 815-40, Contracts
in Entity’s Own Equity, the Company evaluated whether the conversion feature needed to be bifurcated from the host instrument as
a freestanding financial instrument. Under ASC 815-40, to qualify for equity classification (or non-bifurcation, if embedded) the instrument
(or embedded feature) must be both (1) indexed to the issuer’s own stock and (2) meet the requirements of the equity classification
guidance. Based upon the Company’s analysis, it was determined the conversion option is indexed to its own stock and also met all
the criteria for equity classification. Accordingly, the conversion option is not required to be bifurcated from the host instrument
as a derivative.
As
part of the Avenue Financing the Company issued 768,072 warrants to Avenue Capital Group which was equal to 8.5 % of the total funding
commitment. The Avenue Warrants have an exercise price equal $ 1.66 per share, see Note 3.
Repayment of Yorkville Convertible Notes
During the first quarter
of 2025, the Company paid the remaining $ 2.4 million of the Yorkville Convertible Notes of which $ 1.2 million was settled in cash and
$ 1.2 million was settled in shares of common stock.
Insurance Notes
The Company determined that
the carrying amounts of all of the insurance notes approximate fair value due to the short-term nature of borrowings and current market
rates of interest.
16
7. COMMITMENTS AND CONTINGENCIES
Legal Matters
The Company is not a party
to any material legal proceedings or pending claims. From time to time, the Company may be subject to various legal proceedings and claims
that arise in the ordinary course of its business activities, none of which we believe are material or would be expected to have, individually
or in the aggregate, a material adverse effect on our business, financial condition, cash flows or results of operations.
8. STOCKHOLDERS’
DEFICIT
In conjunction with the
Closing, the Company’s certificate of incorporation was amended and restated to authorize the issuance of 80,000,000 shares of
Common Stock, $ 0.0001 par value and 1,000,000 shares of preferred stock, $ 0.0001 par value (the “Preferred Stock”).
During the three months
ended March 31, 2026, 935,000 Pre-Funded Warrants were exercised, at an exercise price per share of $ 0.0001 .
9. STOCK-BASED COMPENSATION
As of March 31, 2026, there
were 3,795,494 shares available for the grant of awards under the Company’s 2023 Long Term Incentive Plan (the “2023
Plan”).
Restricted Stock Units
A summary of RSU activities
for the three months ended March 31, 2026 are presented below:
Number of
Shares
Weighted
Average
Grant Date
Fair Value
per Share
Nonvested as of January 1, 2026
9,700
$ 0.45
Granted
-
$ -
Vested
-
$ -
Forfeited
-
$ -
Nonvested as of March 31, 2026
9,700
$ 0.45
As of March 31, 2026, total
unrecognized compensation expense related to restricted stock units was $ 1.2 thousand, which is expected to be recognized over a weighted-average
period of 0.04 years.
Stock Options
A summary of stock options
activity for the three months ended March 31, 2026 is presented below:
Stock
Options Weighted
Average
Exercise
Price Weighted
Average
Remaining
Contractual
Life
(in years) Aggregate
Intrinsic Value
(in thousands)
Outstanding at January 1, 2026 3,857,138 $ 1.84 6.1 544
Options granted -
$ -
Options forfeited ( 64,810 ) $ 1.83
Options cancelled -
$ -
Options exercised ( 150,000 ) $ 1.04
Outstanding as of March 31, 2026 3,642,328 $ 1.87 5.9 571
Options vested and exercisable as of March 31, 2026 2,951,221 $ 1.94 5.2 440
17
The Company did not grant
any stock options during the three months ended March 31, 2026. As of March 31, 2026, total unrecognized compensation expense related
to stock options was $ 0.3 million, which is expected to be recognized over a weighted-average period of 0.9 years.
The
Company recorded stock-based compensation expense for stock options and RSUs of $ 183 thousand and $ 200 thousand for the three months
ended March 31, 2026 and March 31, 2025, respectively, in general and administrative expenses in the condensed consolidated statements
of operations.
10. NET (LOSS) INCOME PER COMMON SHARE
Basic and diluted net income
(loss) per share was calculated as follows (in thousands, except share and per share data):
Three Months Ended
March 31,
2026
2025
Numerator:
Net income (loss) attributable to common stockholders - basic
$ ( 3,412 )
$ 2,897
Less: Change in fair value of convertible notes
-
( 220 )
Net income (loss) attributable to common stockholders - diluted
$ ( 3,412 )
$ 2,677
Denominator:
Weighted average shares of common stock outstanding - basic
31,756,649
22,986,350
Effective of dilutive securities
-
1,044,168
Weighted average shares of common stock outstanding - diluted
31,756,649
24,030,518
Net income (loss) per share of common stock - basic
$ ( 0.11 )
$ 0.13
Net income (loss) per share of common stock - diluted
$ ( 0.11 )
$ 0.11
The table below summarizes
potentially dilutive securities that were excluded from the above computation of net loss per common share as of the periods presented
because including them would be anti-dilutive.
Three Months Ended
March 31,
2026
2025
Common stock options
3,642,328
1,971,145
Common stock warrants
13,943,422
8,507,311
Unvested restricted stock units
9,700
94,399
Total
17,595,449
10,572,855
11. RELATED PARTY TRANSACTIONS
None.
12. SUBSEQUENT EVENTS
On April 8, 2026, the Company
announced the appointment of David McGuire as the Company’s Chief Financial Officer, filling the vacancy created by Vincent Capone’s
appointment as Chief Executive Officer. In connection with his appointment as Chief Executive Officer on February 10, 2026, the Board
of Directors entered into a new employment agreement with Mr. Capone on April 17, 2026. Copies of the employment agreements for Mr. McGuire
and Mr. Capone were previously filed as exhibits to Current Reports on Form 8-K.
18
Item 2. Management’s Discussion and Analysis of Financial
Condition and Results of Operations
You should read the following
discussion and analysis of our financial condition and results of operations together with the unaudited condensed consolidated financial
statements and related notes included elsewhere in this Quarterly Report on Form 10-Q and with our Annual Report on Form 10-K for the
year ended December 31, 2025 (the “2025 Annual Report”). Some of the information contained in this discussion and analysis
or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business, includes
forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the
section titled “Risk Factors,” in our 2025 Annual Report and in other reports we have filed or may file with the SEC, our
actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following
discussion and analysis.
Overview
We are an artificial intelligence
(“AI”) company focused on predictive medical diagnostics. We operate in one segment. Currently, we are devoting substantially
all of our efforts towards research and development of our DeepView System, an internally developed multi-spectral imaging (“MSI”)
device that has previously received FDA breakthrough device designation (“BDD”) status for an earlier version. Given our
receipt of the UKCA mark for burn indication on our DeepView System, we expect to begin commercialization activities in the United Kingdom
in 2026. Our DeepView System uses proprietary algorithms to distinguish between damaged and healthy human tissue invisible to the naked
eye, providing “Day One” healing assessments. DeepView’s output is specifically engineered to allow the physician to
make a more accurate, timely and informed decision regarding the treatment of the patient’s wound. Our focus has been on the burn
indication which is supported by the BARDA PBS contract.
For burn wounds, a non-healing assessment
could aid the clinician in making an immediate and objective determination for appropriate candidates for surgery, as well as determining
what specific areas of the burn wound will require excision and skin grafting. The Company has completed the enrollment of 164 patients,
including 49 pediatric subjects, representing the full enrollment requirements in its validation study for the De Novo submission. In
participants, the DeepView System has shown superiority in sensitivity and met non-inferiority margin in specificity compared to
clinician assessment. These findings were corroborated by the AI model’s cross-validation in identifying non-healing burn regions. This
represents a significant improvement above the diagnostic accuracy of burn physicians assessing the same population. In addition
to our validation study, we have conducted three large clinical studies with multiple sites across the United States,
enrolling more than 400 patients, including adult and pediatric burn patients.
19
We have not generated any
product revenue to date. We have received substantial support from the U.S. government for our DeepView System’s application
for burn wounds, particularly from the Biomedical Advanced Research and Development Authority (“BARDA”), which is part of
the HHS Office of the Assistant Secretary for Preparedness and Response in the United States, established to aid in securing the
United States from chemical, biological, radiological, and nuclear threats, as well as from pandemic influenza and emerging infectious
diseases. We have also received funding from the National Science Foundation (the “NSF”), the National Institute of Health
(the “NIH”) and the Defense Health Agency (the “DHA”). Since 2013, we have received approximately $281.9
million in funding awards from government contracts, primarily from BARDA, which accounts for $272.9 million. This has allowed us to
develop our technology and further our clinical trials.
In September 2023, we executed
our third contract with BARDA for a multi-year Project BioShield (“PBS”) agreement, valued at up to approximately $150.0
million (the “PBS BARDA Contract”). This included an initial award of approximately $54.9 million to support the clinical
validation study and the distribution of up to 30 DeepView Systems in various burn centers and emergency departments to support our validation
study and approximately another $95.0 million for further follow-on development and procurement activities related to the DeepView System.
The funding also supported the Company’s FDA De Novo submission of our DeepView AI – Burn software, which was completed on
June 30, 2025. In March 2026, BARDA exercised a portion of its contractual options under the contract, providing the Company with (i)
a no-cost extension of the base phase of the contract from March, 2026 to June 2026 and (ii) accelerated funding of approximately $31.7
million for further follow-on development and procurement activities related to the DeepView System. The contract continues to provide
additional options, similar to our prior BARDA contracts, with an additional total value of approximately $63.4 million which can
be exercised for additional product development, and the expanded procurement and deployment of DeepView Systems at emergency rooms,
trauma and burn centers. These deployments will enable the Company to conduct health economic and outcome research studies to support
the broader clinical adoption of the DeepView System. As part of this funding advance, the Company has committed to fund $9.7 million of
the total overall development costs associated with these feature advancements. This contract funding is non-dilutive to our
shareholders, and we believe it validates the important nature of our mission and technology.
In
addition to our PBS BARDA contract, we received a $4.0 million grant award from the Medical Technology Enterprise Consortium (“MTEC”)
in April 2023, which, building on prior awards from the DHA, is to be used to support military battlefield burn evaluation via a handheld
version of the DeepView System device (the “MTEC Agreement”). In August 2024, the MTEC award was increased to $4.9 million
and was extended to run through December 2025 with funding dependent on various milestones. In December 2025, the MTEC contract was extended
to run through June 2026. In March 2024, we received an additional $0.5 million award from the DHA to further this development, for a
total contract value of approximately $2.8 million .
Once commercialized,
we anticipate that the DeepView System will have two revenue streams, a SaMD (software as a medical device) model, and an imaging device
component. The SaMD model applies a SaaS (software as a service) treatment for the DeepView System which will feature a software licensing
fee that includes maintenance, image hosting, and access to algorithm updates. The proprietary imaging device accesses artificial intelligence
algorithms and is a universal platform to house multiple clinical applications. Pricing for these components will be evaluated and strategically
set per country and site-of-service for heightened customer adoption.
20
Business Combination
On September 12, 2023, following
completion of the Business Combination, the Company began trading its shares of the Company Common Stock and the Public Warrants on the
Nasdaq Global Market (the “Nasdaq”) under the symbols “MDAI” and “MDAIW”, respectively.
Key Operating and Financial Metrics
We regularly review a number
of metrics, including the following key operating and financial metrics, to evaluate our business, measure our performance, identify
trends in our business, prepare financial projections and make strategic decisions. We believe the operating and financial metrics presented
are useful in evaluating our operating performance, as they are similar to measures by our public competitors and are regularly used
by security analysts, institutional investors, and other interested parties in analyzing operating performance and prospects. Adjusted
EBITDA is a non-GAAP measure, as it is not a financial measure calculated in accordance with GAAP and should not be considered as
a substitute for net loss, calculated in accordance with GAAP. See “Non-GAAP Financial Measures” for additional
information on adopted non-GAAP financial measures and a reconciliation of these non-GAAP measures to the most comparable GAAP
measures.
Comparison of
Three Months Ended March 31, 2026 and 2025
The following table summarizes
these metrics for the three months ended March 31, 2026 and 2025 (in thousands):
Three Months Ended
March 31,
2026
2025
Change
Research and development revenue
$ 3,991
$ 6,707
$ (2,716 )
Gross profit
2,027
3,168
(1,141 )
Gross margin
50.8 %
47.2 %
3.6 %
Operating loss
(1,971 )
(896 )
(1,075 )
Net income (loss)
(3,412 )
2,897
(6,309 )
Adjusted EBITDA
(1,758 )
(694 )
(1,064 )
See “Non-GAAP Financial
Measures” below for a reconciliation of net loss to Adjusted EBITDA.
Research and Development Revenue
We define research and development
revenue as revenue generated from the research, testing and development of our DeepView System as utilized in connection with our burn
indication. This research and development revenue reflects applied research and experimental development costs relating to our burn application
as developed in connection with our BARDA, MTEC, and DHA contracts.
Gross Profit and Gross Margin
We define gross profit as
research and development revenue, less cost of revenue, and define gross margin, expressed as a percentage, as the ratio of gross profit
to revenue. Gross profit and gross margin can be used to understand our financial performance and efficiency and as we begin commercialization,
it will allow investors to evaluate our pricing strategy and compare against our competitors. Our management uses these metrics to make
strategic decisions, pricing decisions, identifying areas for improvement, set targets for future performance and make informed decisions
about how to allocate resources going forward.
21
Adjusted EBITDA
We define adjusted earnings
before interest, tax, depreciation and amortization (“Adjusted EBITDA”) as net loss excluding income taxes, depreciation
of property and equipment, net interest income, stock compensation, transaction costs and any non-operating financial income and expense.
See “Non-GAAP Financial Measures” for a reconciliation of GAAP net loss to Adjusted EBITDA.
Key Factors that May Influence Future Results of Operations
Our
financial results of operations may not be comparable from period to period due to several factors. Key factors affecting our results
of operations are summarized below.
Revenue Sources. As
a pre-commercialization company, we currently generate revenue almost exclusively from two U.S. governmental agencies. We are
highly dependent upon the continuation of the existing U.S. governmental contract awards, as well as future governmental procurement
or other awards. Our operating results may not be comparable between periods as the timing and amount of awards or procurements from
the U.S. government may be inconsistent with the timing of prior awards and the phasing of the development study schedules may be
different. Our revenues may continue to be almost exclusively dependent upon the terms of those awards.
Gross Margin. When
we begin commercial sales of the DeepView System, we may need to determine lower pricing and incentives to accelerate adoption and implementation
of the DeepView System, which may negatively impact future revenue and gross margin percentages.
Managing our Supply Chain. We
are reliant on contract manufacturers and suppliers to produce our components. While we have not been subject to any disruptions in our
current limited production, we may be subject to component shortages, which may cause delays in critical components and inventory, longer
lead times, increased costs and delays in product shipments. Our ability to grow depends, in part, on the ability of our contract manufacturers
and suppliers to provide high quality services and deliver components and finished products on time and at reasonable costs. While we
do not maintain sole-source suppliers, there is a concentration of suppliers which could lead to supply shortages, long lead times
for components and supply changes. In the event we are unable to mitigate the impact of delays and/or price increases in raw materials,
electronic components and freight, it could delay the manufacturing and installation of our products, which would adversely impact our
cash flows and results of operations, including revenue and gross margin.
Components of Consolidated Statements
of Operations
Research and Development Revenue
To
date, we have not generated any revenues from the sale or license of our products. Our primary source of revenue is research and development
revenue. Currently, we are highly dependent upon the reimbursements from BARDA for the burn diagnostic testing of our DeepView System
and other U.S. government awards. The Company recognizes revenue in accordance with ASC 606, Revenue from Contracts with Customers
(“ASC 606”). The provisions of ASC 606 require the following steps to determine revenue recognition: (1) identify
the contract(s) with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price;
(4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when (or as) the entity
satisfies a performance obligation. The Company’s product revenue is recognized when the performance obligation is satisfied by
transferring control of the promised goods or services to a customer. Our research and development revenue is affected by the amount
of research and development that is expended each month with respect to our contract with BARDA and other U.S. governmental contract
awards, such as our grant under the MTEC Agreement which we earn based on the achievement of milestones and performance milestones. Our
revenue growth is dependent upon a number of factors, including expanding the research and development activities under the BARDA contract,
research and development reimbursed expenses relating to other contract awards from U.S. governmental agencies and the intended future
commercial sales of our DeepView System. See “Liquidity and Capital Resources” for additional information.
22
Cost of Revenue
Our
cost of revenues consists primarily of direct and indirect costs associated with the research and development expenses relating to the
BARDA and MTEC contracts. Our revenue costs are affected by the extent of research and development expenses as well as expansion of work
on other U.S. governmental projects and the expanded applications for our DeepView System.
Gross Profit
Gross
profit may vary from period-to-period and is primarily affected by the current reimbursement rates under the BARDA contract and other
U.S. governmental contract awards. These reimbursement rates are fixed under the BARDA contract. Under the BARDA contract our gross profit
represents this reimbursement rate plus a fixed fee component relating to non-reimbursed expenses incurred in connection with the work
completed. Under the other fixed fee U.S. governmental contract awards our gross profit corresponds to the achievement of pre-determined
milestones
Operating Costs and Expenses
Operating
costs and expenses consist of general and administrative expense. These expenses primarily relate to salaries and related costs of our
organization’s support and operations staff, consulting fees, rent, insurance and office expenses, and our non-revenue generating
research and development expenses, primarily related to salaries and related costs and consulting fees.
Other income (expense)
Other
income (expense) consists of net interest expense, financing related costs related to the Avenue Financing, fees related to the Hudson
Bay Financing, change in the fair value of warrant liability, and foreign exchange transaction gains/losses.. Historic foreign exchange
transaction loss primarily relates to changes in the exchange rate between the U.S. dollar and the British pound sterling for our
deposit accounts that are denominated in British pound sterling. In addition, this amount includes costs associated with buying British
pound sterling for payment of our employees and vendors in the UK.
Results of Operations
The following table summarizes
our results of operations for the three months ended March 31, 2026 and 2025 (in thousands):
Three Months Ended
March 31,
2026
2025
Change
Research and development revenue
$ 3,991
$ 6,707
$ (2,716 )
Cost of revenue
(1,964 )
(3,539 )
1,575
Gross profit
2,027
3,168
(1,141 )
Operating costs and expenses:
General and administrative
3,998
4,064
(66 )
Total operating costs and expenses
3,998
4,064
(66 )
Operating loss
(1,971 )
(896 )
(1,075 )
Other income (expense):
Net interest (expense) income
(258 )
(20 )
(238 )
Financing related costs
(7 )
(581 )
574
Amortization of debt discount
(179 )
-
(179 )
Change in fair value of warrant liability
(1,002 )
4,253
(5,255 )
Change in fair value of notes payable
-
220
(220 )
Foreign exchange transaction loss, net
(5 )
(8 )
3
Total other income (expense), net
(1,451 )
3,864
(5,315 )
Income (loss) before income taxes
(3,422 )
2,968
(6,390 )
Income tax provision
10
(71 )
81
Net income (loss)
$ (3,412 )
$ 2,897
$ (6,309 )
23
Research and Development Revenue
Three Months Ended
March 31,
Change in
2026
2025
$
%
Research and development revenue
$ 3,991
$ 6,707
$ (2,716 )
-40.5 %
Research and development
revenue was $4.0 million for the three months ended March 31, 2026, a decrease of 40.5% compared to the same periods in 2025, reflecting
a decrease in the completed work under the PBS BARDA Contract as the contract progressed to the end of the base phase of such contract,
partially offset by an increase in revenue from the awards and work performed under the Company’s other U.S. governmental contracts.
For the three months ended
March 31, 2026 and 2025, the Company’s revenues disaggregated by the major sources were as follows (in thousands):
Three Months Ended
March 31,
Change in
2026
2025
$
%
BARDA
$ 3,311
$ 6,382
$ (3,071 )
-48.1 %
Other U.S. governmental authorities
680
325
355
109.2 %
Total research and development revenue
$ 3,991
$ 6,707
$ (2,716 )
-40.5 %
Cost of Revenues and Gross Profit
Three Months Ended
March 31,
Change in
(in thousands)
2026
2025
$
%
Cost of revenue
$ 1,964
$ 3,539
$ (1,575 )
-44.5 %
Gross profit
2,027
3,168
(1,141 )
-36.0 %
Gross margin
50.8 %
47.2 %
Cost of revenue for the
three months ended March 31, 2026 was $2.0 million, a decrease of 44.5% compared to the same periods in 2025, due to decreased development
activity to fulfill our U.S. governmental contracts, consistent with the decrease in research and development revenue.
Gross margin for the three
months ended March 31, 2026 was 50.8%, an increase of 3.6% as compared to the same periods in 2025, reflecting a decreased concentration
of direct labor as a component of our overall revenue.
24
General and Administrative Expense
Three Months Ended
March 31,
Change in
2026
2025
$
%
General and administrative expense
$ 3,998
$ 4,064
$ (66 )
-1.6 %
General and administrative
expense was $4.0 million for the three months ended March 31, 2026, a decrease of 1.6%, as compared to the same period in 2025 reflecting
an overall decrease in expense offset by an increase in non-revenue generating research and development activities, primarily related
to salaries and related costs and consulting fees. Additionally, the Company incurred less put option and premium expense for financing
transactions in the current three-month period.
Other income (expense)
Three Months Ended
March 31,
Change in
2026
2025
$
Net interest (expense) income
$ (258 )
$ (20 )
$ (238 )
Financing related costs
(7 )
(581 )
574
Amortization of debt discount
(179 )
-
(179 )
Change in fair value of warrant liability
(1,002 )
4,253
(5,255 )
Change in fair value of notes payable
-
220
(220 )
Foreign exchange transaction loss
(5 )
(8 )
3
Total other income (expense), net
$ (1,451 )
$ 3,864
$ (5,315 )
Net interest expense for
the three months ended March 31, 2026 primarily relate to interest expense associated with the Avenue Financing as well as costs related
to the Company’s insurance policy financing.
Financing related costs
decreased $0.6 million for the three months ended March 31, 2026, as compared to the comparable period in 2025 primarily due to the elimination
of the expenses relating to the Company’s prior financings that were expensed during fiscal year 2025. Amortization of debt discount
of $0.2 million for the three months ended March 31, 2026 relates to amortization of the discount on the Avenue note payable.
Change in fair value of
warrant liability increased by approximately $5.3 million for the three months ended March 31, 2026 as compared to the comparable period
in 2025. Change in fair value of warrant liability was an expense of $1.0 million for the three months ended March 31, 2026, as compared
to a benefit of $4.3 million for same period in 2025. The changes reflect fluctuations in the fair value of the Company’s warrants
during the three-month period ended March 31, 2026. The Company’s warrants are classified as liabilities and remeasured to fair
value at each reporting period, with changes recognized in net loss. As a result, fluctuations in the warrant price of Public Warrants
and fluctuations in the fair value of other outstanding warrants may cause significant non-cash gains or losses, leading to volatility
in reported net loss.
Foreign exchange transaction
loss for the three months ended March 31, 2026 and 2025 is immaterial due to lower balances in our deposit accounts and accounts payable
denominated in British pound sterling and less fluctuation in the exchange rate between the U.S. dollar and the British pound sterling.
In addition, these amounts include costs associated with buying British pound sterling for payment of our employees and vendors in the
UK.
25
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, net interest income, stock compensation, transaction costs
and any non-operating financial income and expense.
The following table presents
our Adjusted EBITDA for the three months ended March 31, 2026 and 2025 (in thousands):
Three Months Ended
March 31,
2026
2025
Net Income (loss)
$ (3,412 )
$ 2,897
Adjust:
Depreciation expense
30
2
Provision for income taxes
(10 )
71
Net interest (expense) income
258
20
EBITDA
(3,134 )
2,990
Additional adjustments:
Stock-based compensation
183
200
Financing related costs
7
581
Amortization of debt discount
179
-
Change in fair value of warrant liability
1,002
(4,253 )
Change in fair value of notes payable
-
(220 )
Foreign exchange transaction loss
5
8
Adjusted EBITDA
$ (1,758 )
$ (694 )
Liquidity and Capital Resources
Sources of Liquidity
As
of March 31, 2026 and December 31, 2025, the Company had approximately $11.7 million and $15.4 million, respectively, in cash, and an
accumulated deficit of $59.2 million and $55.8 million, respectively. As of March 31, 2026 and December 31, 2025, the Company had approximately
$8.4 million and $8.4 million, respectively, of debt outstanding of which $4.5 million and $5.5 million represented long-term debt as
of such periods, respectively.
On March 18, 2026, the Company
announced that it has received a contract modification from BARDA for the acceleration of $31.7 million from its existing contract
with BARDA which included (i) a no-cost extension of the base phase of the contract, and (ii) the acceleration of certain parts of the
next phase of such contract. As part of this funding advance, the Company has committed to fund $9.7 million of the total
overall development costs associated with these feature advancements. This funding comes as part of an ongoing partnership with
BARDA, which has committed $86.6 million to date under the contract with an overall value of approximately $150 million.
The Avenue Financing also included warrant coverage equal to 8.5% of the total funding commitment from Avenue, with an exercise price
equal to the lower of (i) average of the daily volume weighted average price of Common Stock as reported for each of five (5) consecutive
trading days, determined as of the end of the trading on the last trading day before the date of issuance, which was $1.66 and (ii) the
lowest price per share paid to the Company by cash investors for Common Stock issued in any sale of Common Stock in a bona-fide equity
raising that closes at any time commencing from March 21, 2025 through (but excluding) December 31, 2025.
On March 21, 2025, as a condition to the Avenue Financing, the Company entered into securities purchase agreements with certain investors
in the United States and the United Kingdom for the sale of an aggregate of 2,076,923 shares of the Company’s Common Stock, at an
offering price of $1.30 per Share which raised an additional $2.7 million.
26
As of March 31, 2026,
based on our current operating plan, we believe that our cash and cash equivalents, together with the PBS BARDA Contract, the MTEC
Agreement, the Avenue Financing, the Hudson Bay Financing, the Yorkville SEPA and certain research and development cost-saving
measures, the Company believes it has, sufficient working capital to fund operations for at least one year beyond the release date
of the condensed consolidated financial statements. We have based this determination on assumptions that may prove to be wrong, and
we could utilize our available capital resources sooner than we currently expect. Changing circumstances could also cause us to
consume capital significantly faster than we currently anticipate, and we may need to raise capital sooner or in greater amounts
than currently expected because of circumstances beyond our control. To the extent additional capital is necessary, there are no
assurances that we will be able to raise additional capital on favorable terms or at all, and therefore we may not be able to
execute our business plans and the continued work on indications beyond expanding our burn indication.
Cash Flows
The
following table summarizes our cash flows for the three months ended March 31, 2026 and 2025 (in thousands):
Three Months Ended
March 31,
2026
2025
Net cash used in operating activities
$ (3,728 )
$ (1,505 )
Net cash provided by (used in) financing activities
(1 )
10,392
Cash Flows Used in
Operating Activities
Net
cash used in operating activities increased to approximately $3.7 million for the three months ended March 31, 2026, as compared
to $1.5 million for the three months ended March 31, 2025, primarily driven by a higher net operating loss as a result of reduced reimbursed
research and development revenue, based on lower BARDA activity, and higher cash used from changes in operating assets and liabilities,
primarily due to a decrease in accounts payable.
Cash Flows Provided
by Financing Activities
Net
cash used by financing activities for the three months ended March 31, 2026 reflects repayments of insurance notes payable, offset by
proceeds received from the exercise of stock options. Net cash provided by financing activities of $10.4 million for the three months
ended March 31, 2025 was primarily attributable to proceeds from the Avenue Financing of $8.3 million, proceeds from the exercise of
common stock warrants of $2.0 million and the attendant equity raise of $3.1 million, partially offset by the loan repayments on the
Yorkville debt facility.
Current Indebtedness
The
Company has the ability with the LSA to borrow up to $15.0 million in funding from Avenue with an initial drawdown of $8.5 million from
the Avenue Financing.
The
loans under the LSA mature on March 1, 2028, with an interest-only payment period of no less than 15 months, which can be extended to
24 months upon the achievement of certain milestones prior to the end of such 15 month period as described in the Tranche 2 Milestone
Date (as defined in the Supplement). The Tranche 2 Commitment (as defined in the Supplement) includes an additional $6.5 million in debt
financing and is contingent upon, among other things, (i) U.S. FDA’s clearance of the Company’s DeepView System and (ii)
an additional $7.0 million equity raise to be completed by the Company.
The
Avenue Financing also includes warrant coverage equal to 8.5% of the total funding commitment from Avenue, with an exercise price equal
to the lower of (i) average of the daily volume weighted average price of Common Stock as reported for each of five (5) consecutive trading
days, determined as of the end of the trading on the last trading day before the date of issuance, which was $1.66 and (ii) the lowest
price per share paid to the Company by cash investors for Common Stock issued in any sale of Common Stock in a bona-fide equity raising
that closes at any time commencing from March 21, 2025 through (but excluding) December 31, 2025.
27
Related Party Transactions
For the three-month period
ended March 31, 2026, the Company did not have any related party transactions.
Off-Balance Sheet
Arrangements
During
the periods presented, we did not have any off-balance sheet arrangements, as defined in Item 303(a)(4)(ii) of SEC Regulation S-K.
Critical Accounting
Policies
Our
management’s discussion and analysis of our financial condition and results of operations is based on our condensed consolidated
financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States. The
preparation of these condensed consolidated financial statements and related disclosures requires us to make estimates and assumptions
that affect the reported amounts of assets and liabilities, costs and expenses and the disclosure of contingent assets and liabilities
in our financial statements and accompanying notes. On an ongoing basis, we evaluate our estimates which include, but are not limited
to, revenue recognition, warrant liabilities, fair value of certain debt, stock-based compensation expense, stock issued for transaction
costs, the net realizable value of inventory, right-of-use assets, and income tax valuation allowances. We base our estimates on historical
experience, known trends and events and various other factors that we believe to be reasonable under the circumstances, the results of
which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other
sources. Actual results could differ from those estimates under different assumptions or conditions.
Our
critical accounting policies are described under the heading “Management’s Discussion and Analysis of Financial Condition
and Results of Operations — Critical Accounting Policies” in our Annual Report on Form 10-K for the year ended December 31,
2025, which was filed with the SEC on March 25, 2026. During the three months ended March 31, 2026, there were no material changes to
our critical accounting policies from those previously disclosed.
Recent Accounting Pronouncements
See
Note 2, Recent Accounting Pronouncements, of the notes to our condensed consolidated financial statements included elsewhere in this
Form 10-Q for recently adopted accounting standards and recently issued accounting standards as of the dates of the statement of financial
position included in this Form 10-Q.
Emerging Growth Company
We
are an emerging growth company, as defined in the JOBS Act. The JOBS Act provides that an emerging growth company can take advantage
of an extended transition period for complying with new or revised accounting standards. This provision allows an emerging growth company
to delay the adoption of some accounting standards until those standards would otherwise apply to private companies. We have elected
to use the extended transition period under the JOBS Act for the adoption of certain accounting standards until the earlier of the date
we (i) are no longer an emerging growth company or (ii) affirmatively and irrevocably opt out of the extended transition period
provided in the JOBS Act. As a result, our financial statements may not be comparable to companies that comply more promptly with new
or revised accounting pronouncements as of public company effective dates.
In
addition, as an emerging growth company, we may take advantage of specified reduced disclosure and other requirements that are otherwise
applicable generally to public companies. These provisions include:
●
being permitted to present
only two years of audited consolidated financial statements in addition to any required unaudited interim consolidated financial
statements, with correspondingly reduced disclosure in the section titled “Management’s Discussion and Analysis of Financial
Condition and Results of Operations”;
●
an exception from compliance
with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended;
●
reduced disclosure about
our executive compensation arrangements in our periodic reports, proxy statements and registration statements;
●
exemptions from the requirements
of holding non-binding advisory votes on executive compensation or golden parachute arrangements; and
28
We
may take advantage of these provisions until the last day of the fiscal year ending after the fifth anniversary of the Company’s
initial public offering or such earlier time that we no longer qualify as an emerging growth company. We will cease to qualify as an
emerging growth company on the date that is the earliest of: (i) December 31, 2026; (ii) the last day of the fiscal year in which we
have more than $1.235 billion in total annual gross revenues; (iii) the date on which we are deemed to be a “large accelerated
filer” under the rules of the SEC, which means the market value of our common stock that is held by non-affiliates exceeds $700.0
million as of the prior June 30th and we have been a public company for at least 12 months and have filed one annual report on Form 10-K;
or (iv) the date on which we have issued more than $1.0 billion of non-convertible debt over the prior three-year period. We may choose
to take advantage of some but not all of these reduced reporting burdens. Accordingly, the information contained herein may be different
than you might obtain from other public companies in which you hold equity interests.
We are also a “smaller
reporting company.” If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue
to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller
reporting company, we may choose to present only the two most recent fiscal years of audited consolidated financial statements in our
Annual Report and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive
compensation.
Quantitative and
Qualitative Disclosures About Market Risk
We
are exposed to market risks in the ordinary course of our business. These risks primarily include interest rate, foreign exchange, credit
and inflation risks.
Interest Rate
Sensitivity
We
maintain a large amount of our assets in cash. Our cash is held primarily in cash deposits. The fair value of our cash would not be significantly
affected by either an increase or decrease in interest rates due mainly to the short-term nature of these instruments. Additionally,
changes to interest rates will impact on the cost of any future borrowings. With respect to our current borrowings, the interest rates
on the notes are Prime plus 5%. Changes in prevailing interest rates could have a material impact on our results of operations.
Foreign Currency
Risk
Our
revenue is denominated in U.S. dollars. Our expenses are generally denominated in the currencies in which our operations are located,
which is primarily in the United States and United Kingdom, with an insignificant portion of expenses incurred in our wholly owned
subsidiaries in the UK and denominated in British pound sterling.
Credit
Risk
Financial
instruments that subject us to concentrations of credit risk consist primarily of cash and accounts receivable. The vast majority of
our cash is held in U.S. financial institutions which, at times, exceed federally insured limits. We have not recognized any losses
from credit risks on such accounts. We believe we are not exposed to significant credit risk on cash.
Additional
credit risk is related to our concentration of receivables and revenues. One customer (which is a U.S. government agency) represents
the majority of our research and development revenue and accounts receivable.
Inflation Risk
If
the cost of our products, employee costs, or other costs continue to be subject to significant inflationary pressures, such inflationary
pressure may have an adverse effect on our ability to maintain current levels of gross margin and selling, general and administrative
expense. As a result, our inability to quickly respond to inflation could harm our cash flows and results of operations in the future.
29
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Not required for smaller reporting companies.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our management is responsible
for establishing and maintaining adequate internal control over financial reporting (as that term is defined in Rules 13a-15(f) and 15d-15(f)
under the Exchange Act). Our management, under the supervision of our Chief Executive Officer and Chief Financial Officer, has evaluated
the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, as of
the end of the period covered by this Annual Report on Form 10-K.
Material Weakness:
Our financial statement close process controls, including controls over account reconciliations, transaction processing, and financial
reporting review, did not operate consistently or with sufficient precision to ensure timely performance and review, including appropriate
oversight of financial statement reporting. In conducting our evaluation, management used the updated framework issued by the Committee
of Sponsoring Organizations of the Treadway Commission (“COSO”) in Internal Control-Integrated Framework (2013). Disclosure
controls and procedures are designed to ensure that information required to be disclosed by a company in the reports that it files or
submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules
and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information
required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated
to our management, including our principal executive and principal financial officers, as appropriate to allow timely decisions regarding
required disclosure.
Based on that evaluation,
management concluded that, as of March 31, 2026, our disclosure controls and procedures were not effective due to the material weakness
in internal control over financial reporting described below. As discussed in Item 9A of our Form 10-K for the year ended December 31,
2025, we identified a material weakness in our internal control over financial reporting as well as a lack of effective controls over
the COSO principles including control environment, risk assessment, control activities, information and communications and monitoring
as of December 31, 2025.
Remediation Plan for Material Weakness
Remediation generally requires
making changes to how controls are designed and implemented and then adhering to those changes for a sufficient period of time such that
the effectiveness of those changes is demonstrated with an appropriate amount of consistency. In response to the material weakness, we
implemented, and are continuing to implement and monitor, measures designed to improve our internal control over financial reporting.
These efforts include:
●
engaging a professional
accounting services firm, in 2024, to help us assess and commence documentation of our internal controls for complying with the Sarbanes-Oxley
Act of 2002;
●
Engaged consultants to
provide additional technical accounting expertise;
●
During 2025, enhanced functionality
of our enterprise resource planning system to support certain key financial processes and controls and enforce certain segregation
of duties through automation and approval workflows; and
●
Improved accounting personnel
by supplementing capacity gaps. We will continue to make additional accounting hires to further bolster capabilities.
The measures we implemented
are subject to continued management review supported by confirmation and testing, as well as audit committee oversight. Management and
the Audit Committee remain committed to the implementation of remediation efforts to address the material weakness. We will continue
to implement measures to remedy our internal control deficiencies, though there can be no assurance that our efforts will be successful
or avoid potential future material weaknesses. In addition, until remediation steps have been completed and are operated for a sufficient
period of time, and subsequent evaluation of their effectiveness is completed, the material weaknesses previously disclosed, and as described
above, will continue to exist
Changes in Internal Control over Financial
Reporting
Except for the remediation
efforts in connection with the material weakness described above, there were no changes in our internal control over financial reporting
(as defined in Rule 13a-15(f) of the Exchange Act) that occurred during the quarter ended March 31, 2026 that has materially affected,
or is reasonably likely to materially affect, our internal control over financial reporting.
30
PART II - OTHER INFORMATION
Item 1. Legal Proceedings
The Company is not a party
to any material legal proceedings or pending claims. From time to time, the Company may be subject to various legal proceedings and claims
that arise in the ordinary course of its business activities, none of which we believe are material or would be expected to have, individually
or in the aggregate, a material adverse effect on our business, financial condition, cash flows or results of operations.
Item 1A. Risk Factors
Factors that could cause
our actual results to differ materially from those in this Quarterly Report include the risk factors described in our Annual Report on
Form 10-K filed with the SEC on March 25, 2026 and in the Registration Statement on Form S-4 filed with the SEC on January 5, 2024, as
amended. Any of those factors could result in a significant or material adverse effect on our results of operations or financial condition.
Additional risk factors not presently known to us or that we currently deem immaterial may also impair our business or results of operations.
As of the date of this Quarterly Report, there have been no material changes to the risk factors disclosed in our Annual Report on Form
10-K filed with the SEC on March 25, 2026 and in the Registration Statement on Form S-4 filed with the SEC on January 5, 2024, as amended.
We may disclose changes to such factors or disclose additional factors from time to time in our future filings with the SEC.
Item 2. Unregistered Sales of Equity Securities
and Use of Proceeds
None .
Use of Proceeds
There has been no material
change in the planned use of the proceeds from the Business Combination, as is described in the Company’s final prospectus (Registration
No. 333-275218), as filed with the SEC on January 2, 2024. Additionally, there has been no material change in the planned use of proceeds
from the Avenue Financing, as is described in the Company’s Current Report on Form 8-K as filed with the SEC on March 26, 2025.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
None.
Item 5. Other Information
None .
Item 6. Exhibits
The following exhibits are
filed as part of, or incorporated by reference into, this Quarterly Report on Form 10-Q:
No.
Description
of Exhibit
2.1
Business
Combination Agreement, dated as of April 11, 2023, by and among Rosecliff Acquisition Corp I, Ghost Merger Sub I Inc., Ghost Merger
Sub II and Spectral MD Holdings Ltd. (incorporated by reference to the Company’s Form 8-K, filed with the SEC on April 17,
2023).
31.1*
Certification of Principal Executive Officer
31.2*
Certification of Chief Financial Officer (Principal Financial and Accounting Officer)
32**
18 U.S.C. Section 1350 Certification
101.INS*
Inline XBRL Instance Document.
101.SCH*
Inline XBRL Taxonomy Extension Schema Document.
101.CAL*
Inline XBRL Taxonomy Extension Calculation Linkbase
Document.
101.DEF*
Inline XBRL Taxonomy Extension Definition Linkbase
Document.
101.LAB*
Inline XBRL Taxonomy Extension Label Linkbase Document.
101.PRE*
Inline XBRL Taxonomy Extension Presentation Linkbase
Document.
104
Cover Page Interactive Data File (formatted as Inline
XBRL and contained in Exhibit 101).
*
Filed herewith.
**
Furnished herewith.
31
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 thereunto duly authorized.
SPECTRAL AI, INC.
Date: May 12, 2026
By:
/s/ Vincent
S. Capone
Name:
Vincent S. Capone
Title:
Chief Executive Officer
(Principal Executive Officer)
Date: May 12, 2026
By:
/s/
Thomas Spieth
Name:
Thomas Spieth
Title:
Controller
(Principal Financial and Accounting Officer)
32
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.