Company Continues to Advance Towards First Commercial Sales of the DeepView® System for Burn Indication
Strong Cash Position of
“Spectral AI has entered the second half of 2026 with tremendous momentum and a clear sense of purpose,” said
Select Business Highlights
- In
May 2026 , receivedFDA clearance for the DeepView System for Burn Indication; with this classification,Spectral AI is now authorized to commence commercial distribution activities inthe United States . - In
March 2026 , awarded$31.7 million of advanced funding from theBiomedical Advanced Research and Development Authority (“BARDA”) to accelerate and support additional development and procurement for the DeepView System. - Following the receipt of
FDA clearance for the DeepView System, drew$6.5 million under our existing credit facility withAvenue Capital Group , providing non-dilutive capital to further strengthen the Company’s balance sheet. - Expanded leadership team in advance of commercial activities, including the appointments of
David McGuire as Chief Financial Officer andDarcy Bajko as Chief Commercial Officer. - Completed all remaining milestones under our
Department of Defense contract for the DeepView System handheld device, contracted through theMedical Technology Enterprise Consortium (“MTEC”), including the delivery of a fully functioning prototype device. - Commenced label expansion of the DeepView System to include heads, hands and feet through an extended study based in the
United Kingdom .
Anticipated Operational and Commercial Milestones
- Generate first-ever commercial sales of the DeepView System in the
U.S . by year end 2026. - Complete UKCA authorization label expansion to reflect the
FDA approved DeepView System for sales in either theUnited Kingdom ,Australia , orGulf Cooperation Council countries by year end 2026. - Initiate Triage and Treatment Outcome Study in Q4 2026 to demonstrate that the DeepView System’s wound assessments improve surgical precision and accelerate treatment decisions, leading to a better overall patient care journey and reduced length of stay.
2026 Second Quarter (“Q2 2026”) Financial Results Overview
All comparisons for Q2 2026 and the six months ended
Research & Development Revenue
Research & Development revenue for Q2 2026 was
“We view the triggering of the cost-share component under our contract with BARDA as an indicator of program maturity,” said
For YTD 2026, Research & Development revenue was
Gross Margin
Gross margin for Q2 2026 was 31.6%, down from 45.2%. The decline reflects the cost-share provisions of the follow-on development phase of the BARDA PBS Contract described above, under which the Company continues to incur development costs that are not fully reimbursable. A slightly lower realized margin on the Company’s fixed-fee MTEC contract also contributed to the reduction.
For YTD 2026, gross margin was 41.8%, down from 46.4%. The decline primarily reflects the lower proportion of costs billed under the follow-on development phase of the BARDA PBS Contract. This was partially offset by the higher gross margin realized in the first quarter of 2026, prior to the commencement of that phase.
Operating Expenses
As we transition from mainly development activities to mixed development and commercial activities, we have disaggregated our reporting of G&A costs to break out development, sales and marketing and administrative costs in order to provide investors with clearer and more meaningful visibility of our evolving cost base.
Operating expenses in Q2 2026 were
For YTD 2026, operating expenses were
Total Other (Expense) / Income
Total other income in Q2 2026 was
For YTD 2026, total other expense was
Net (Loss) Income
Net loss for Q2 2026 was
For YTD 2026, net loss was
Adjusted EBITDA
Adjusted EBITDA, a non-GAAP financial measure, was
Financial Condition
As of
2026 Guidance
The Company is reiterating revenue of approximately
CONFERENCE CALL
The Company will host a conference call today at
- 833-890-6620 –
U.S .
- 412-564-3789 – International
A simultaneous webcast of the call may be accessed online from the Events section of the Investor Relations page of the Company’s website at https://investors.spectral-ai.com/news-events/events.
About Spectral AI
Spectral AI, Inc. is a Dallas-based predictive AI company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, with initial applications involving patients with burns. The Company is working to revolutionize the management of wound care by “Seeing the Unknown®” with its DeepView System. The DeepView System is a predictive diagnostic device that offers physicians an objective and immediate assessment of a wound’s healing potential prior to treatment or other medical intervention. With algorithm-driven results and a goal to exceed the current standard of care, the DeepView System provides fast and accurate treatment insights to improve patient outcomes and reduce healthcare costs. Spectral AI has been named to TIME’s list of World’s Top HealthTech companies 2025. For more information about the DeepView System, visit www.spectral-ai.com.
Non-GAAP Financial Measures
This release contains Adjusted EBITDA, a financial measure that is not calculated in accordance with generally accepted accounting principles in the United States (“GAAP”). The Company defines Adjusted EBITDA as net loss before income taxes, depreciation of property and equipment and net interest expense, further adjusted to exclude stock-based compensation, financing related costs, changes in the fair value of warrant liabilities and notes payable, foreign exchange transaction gains and losses, and transaction costs.
Management uses Adjusted EBITDA to evaluate the Company’s operating performance, identify trends, prepare budgets and financial projections, and allocate resources. The Company believes Adjusted EBITDA is useful to investors because it excludes items that management does not consider indicative of core operating performance — principally non-cash remeasurements of the fair value of the Company’s warrant liabilities, which can fluctuate significantly from period to period based on the Company’s share price and are outside management’s control — thereby facilitating comparisons between periods and with other companies that report similar measures. The Company also excludes stock-based compensation because it is a non-cash expense whose amount in any period reflects the timing and size of equity awards and valuation inputs such as the Company’s share price at the date of grant, rather than the Company’s underlying operating activities, and can therefore vary significantly from period to period.
Adjusted EBITDA has limitations as an analytical tool and should not be considered in isolation, or as a substitute for or superior to net loss or any other measure prepared in accordance with GAAP. Among other limitations, Adjusted EBITDA excludes net interest expense, which represents a recurring cash cost of the Company’s borrowings; excludes income taxes; excludes stock-based compensation, which is a recurring non-cash expense the Company expects to continue to incur and which is an important component of employee compensation; and does not reflect capital expenditures, working capital requirements or other cash requirements. Adjusted EBITDA is a performance measure and should not be construed as a measure of liquidity or of the cash flows generated by the Company’s operating, investing or financing activities. Because non-GAAP measures are not standardized, the Company’s Adjusted EBITDA may not be comparable to similarly titled measures reported by other companies.
A reconciliation of net loss, the most directly comparable GAAP measure, to Adjusted EBITDA is included in the financial tables accompanying this release.
Forward-Looking Statements
Certain statements made in this release are “forward looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s strategy, plans, objectives, initiatives and financial outlook. When used in this press release, the words “estimates,” “projected,” “expects,” “anticipates,” “forecasts,” “plans,” “intends,” “believes,” “seeks,” “may,” “will,” “should,” “future,” “propose” and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside Company’s control, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. As such, readers are cautioned not to place undue reliance on any forward-looking statements.
Investors should carefully consider the foregoing factors, and the other risks and uncertainties described in the “Risk Factors” sections of the Company’s filings with the US Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the other documents filed by the Company. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements.
Investors:
The Equity Group
Devin Sullivan, Managing Director
Devin.Sullivan@theequitygroup.com
Conor Rodriguez, Associate
Conor.Rodriguez@theequitygroup.com
Unaudited Condensed Consolidated Balance Sheets (in thousands, except share and per share data) | |||||||
| 2026 | 2025 | ||||||
| (unaudited) | |||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 13,980 | $ | 15,394 | |||
| Accounts receivable, net | 1,181 | 1,267 | |||||
| Inventory | 815 | 838 | |||||
| Prepaid expenses | 494 | 821 | |||||
| Other current assets | 1,322 | 1,133 | |||||
| Total current assets | 17,792 | 19,453 | |||||
| Non-current assets: | |||||||
| Property and equipment, net | 198 | 258 | |||||
| Right-of-use assets | 1,109 | 1,407 | |||||
| Other assets | 337 | 287 | |||||
| Total Assets | $ | 19,436 | $ | 21,405 | |||
| Liabilities and Stockholders’ Deficit | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 1,725 | $ | 3,010 | |||
| Accrued expenses | 1,708 | 2,341 | |||||
| Deferred revenue | 21 | 154 | |||||
| Lease liabilities, short-term | 776 | 734 | |||||
| Notes payable | 3,859 | 2,854 | |||||
| Warrant liabilities | 11,780 | 11,533 | |||||
| Total current liabilities | 19,869 | 20,626 | |||||
| Notes payable, long-term | 11,055 | 5,538 | |||||
| Lease liabilities, long-term | 566 | 968 | |||||
| Total Liabilities | 31,490 | 27,132 | |||||
| Commitments and contingencies | |||||||
| Stockholders’ Deficit | |||||||
| Preferred stock ( | — | — | |||||
| Common stock ( | 3 | 3 | |||||
| Additional paid-in capital | 51,302 | 50,030 | |||||
| Accumulated other comprehensive income | 29 | 40 | |||||
| Accumulated deficit | (63,388 | ) | (55,800 | ) | |||
| Total Stockholders’ Deficit | (12,054 | ) | (5,727 | ) | |||
| Total Liabilities and Stockholders’ Deficit | $ | 19,436 | $ | 21,405 | |||
Unaudited Condensed Consolidated Statements of Operations (in thousands, except share and per share data) | |||||||||||||||||||
| Three Months Ended | Six Months Ended | ||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||||||||
| Research and development revenue | $ | 3,524 | $ | 5,065 | $ | 7,515 | $ | 11,772 | |||||||||||
| Cost of revenue | (2,411 | ) | (2,775 | ) | (4,375 | ) | (6,314 | ) | |||||||||||
| Gross profit | 1,113 | 2,290 | 3,140 | 5,458 | |||||||||||||||
| Operating expenses: | |||||||||||||||||||
| Research and development | 1,696 | 1,457 | 3,258 | 2,770 | |||||||||||||||
| General and administrative | 3,088 | 2,616 | 5,316 | 5,061 | |||||||||||||||
| Selling and marketing | 653 | 340 | 861 | 646 | |||||||||||||||
| Total operating expenses | 5,437 | 4,413 | 9,435 | 8,477 | |||||||||||||||
| Operating loss | (4,324 | ) | (2,123 | ) | (6,295 | ) | (3,019 | ) | |||||||||||
| Other income (expense): | |||||||||||||||||||
| Net interest expense | (378 | ) | (397 | ) | (815 | ) | (417 | ) | |||||||||||
| Financing related costs | (5 | ) | (4 | ) | (12 | ) | (585 | ) | |||||||||||
| Change in fair value of warrant liability | 711 | (5,449 | ) | (291 | ) | (1,196 | ) | ||||||||||||
| Change in fair value of notes payable | — | — | — | 220 | |||||||||||||||
| Foreign exchange transaction loss, net | (10 | ) | (14 | ) | (15 | ) | (22 | ) | |||||||||||
| Total other income (expense), net | 318 | (5,864 | ) | (1,133 | ) | (2,000 | ) | ||||||||||||
| Loss before income taxes | (4,006 | ) | (7,987 | ) | (7,428 | ) | (5,019 | ) | |||||||||||
| Income tax provision | (170 | ) | 19 | (160 | ) | (52 | ) | ||||||||||||
| Net loss | $ | (4,176 | ) | $ | (7,968 | ) | $ | (7,588 | ) | $ | (5,071 | ) | |||||||
| Net loss per share of common stock | |||||||||||||||||||
| Basic | $ | (0.13 | ) | $ | (0.31 | ) | $ | (0.24 | ) | $ | (0.21 | ) | |||||||
| Diluted | $ | (0.13 | ) | $ | (0.31 | ) | $ | (0.24 | ) | $ | (0.21 | ) | |||||||
| Weighted-average common shares outstanding | |||||||||||||||||||
| Basic | 32,080,874 | 25,421,560 | 31,922,459 | 24,409,550 | |||||||||||||||
| Diluted | 32,080,874 | 25,421,560 | 31,922,459 | 24,409,550 | |||||||||||||||
| Other comprehensive income (loss): | |||||||||||||||||||
| Foreign currency translation adjustments | $ | (1 | ) | $ | 32 | $ | (11 | ) | $ | 49 | |||||||||
| Total comprehensive loss | $ | (4,177 | ) | $ | (7,936 | ) | $ | (7,599 | ) | $ | (5,022 | ) | |||||||
Beginning on
Unaudited Condensed Consolidated Statements of Cash Flows (in thousands) | |||||||
| Six Months Ended | |||||||
| 2026 | 2025 | ||||||
| Cash flows from operating activities: | |||||||
| Net loss | $ | (7,588 | ) | $ | (5,071 | ) | |
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
| Depreciation expense | 60 | 12 | |||||
| Amortization of debt issuance costs | 339 | 120 | |||||
| Stock-based compensation | 990 | 611 | |||||
| Amortization of right-of-use assets | 298 | 280 | |||||
| Change in fair value of warrant liabilities | 291 | 1,196 | |||||
| Change in fair value of notes payable | — | (220 | ) | ||||
| Issuance of shares for borrowing related costs | — | 241 | |||||
| Changes in operating assets and liabilities: | |||||||
| Accounts receivable | 86 | 1,038 | |||||
| Inventory | 23 | (37 | ) | ||||
| Prepaid expenses | 327 | 355 | |||||
| Other assets | (239 | ) | 132 | ||||
| Accounts payable | (1,285 | ) | (2,049 | ) | |||
| Accrued expenses | (634 | ) | (663 | ) | |||
| Deferred revenue | (133 | ) | (536 | ) | |||
| Lease liabilities | (360 | ) | (276 | ) | |||
| Net cash used in operating activities | (7,825 | ) | (4,867 | ) | |||
| Cash flows from financing activities: | |||||||
| Proceeds from issuance of common stock and warrants | 5 | 3,080 | |||||
| Proceeds from notes payable | 6,500 | 8,260 | |||||
| Payments for notes payable | (317 | ) | (1,313 | ) | |||
| Proceeds from warrant exercises | 54 | — | |||||
| Stock option exercises | 180 | 158 | |||||
| Net cash provided by financing activities | 6,422 | 10,185 | |||||
| Effect of exchange rate changes on cash | (11 | ) | 49 | ||||
| Net increase (decrease) in cash | (1,414 | ) | 5,367 | ||||
| Cash, beginning of period | 15,394 | 5,157 | |||||
| Cash, end of period | $ | 13,980 | $ | 10,524 | |||
| Supplemental cash flow information: | |||||||
| Cash paid for interest | $ | 587 | $ | 11 | |||
| Cash paid for taxes | $ | 44 | $ | 1 | |||
| Noncash investing and financing activities disclosure: | |||||||
| Tenant improvement allowance payments made by the lessor directly to a third party | $ | — | $ | (327 | ) | ||
| Issuance of common stock to settle notes payable | $ | — | $ | 1,192 | |||
Reconciliation of Net Loss to Adjusted EBITDA (Non-GAAP) (in thousands) | |||||||||||||||
| Three Months Ended | Six Months Ended | ||||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||||
| Net loss | $ | (4,176 | ) | $ | (7,968 | ) | $ | (7,588 | ) | $ | (5,071 | ) | |||
| Adjust: | |||||||||||||||
| Depreciation expense | 30 | 10 | 60 | 12 | |||||||||||
| Provision for income taxes | 170 | (19 | ) | 160 | 52 | ||||||||||
| Net interest expense | 378 | 397 | 815 | 417 | |||||||||||
| EBITDA | (3,598 | ) | (7,580 | ) | (6,553 | ) | (4,590 | ) | |||||||
| Additional adjustments: | |||||||||||||||
| Stock-based compensation | 807 | 411 | 990 | 611 | |||||||||||
| Financing related costs | 5 | 4 | 12 | 585 | |||||||||||
| Change in fair value of warrant liability | (711 | ) | 5,449 | 291 | 1,196 | ||||||||||
| Change in fair value of notes payable | — | — | — | (220 | ) | ||||||||||
| Foreign exchange transaction loss, net | 10 | 14 | 15 | 22 | |||||||||||
| Adjusted EBITDA | $ | (3,487 | ) | $ | (1,702 | ) | $ | (5,245 | ) | $ | (2,396 | ) | |||
Source: