Indicate by check mark whether the registrant
files or will file annual reports under cover of Form 20-F or Form 40-F.
This Report of Foreign Private Issuer on Form 6-K (the “Form
6-K”) consists of the 2026 Interim Report of MDxHealth SA (the “Company”), which is attached hereto as Exhibit 99.1.
Additionally, the Company confirms the accuracy of the Company’s preliminary financial results included in the press release filed
by the Company as Exhibit 99.1 to Form 6-K with the Securities and Exchange Commission on August 13, 2026.
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.
Exhibit 99.1

2026 INTERIM REPORT
TABLE OF CONTENTS
| I. INTERIM MANAGEMENT REPORT |
|
2 |
| II. INTERIM CONDENSED UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS MDXHEALTH SA |
|
4 |
| 1. CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME |
|
4 |
| 2. CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF FINANCIAL POSITION |
|
5 |
| 3. CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF CHANGES IN EQUITY |
|
6 |
| 4. CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF CASH FLOWS |
|
7 |
| 5. EXPLANATORY NOTES |
|
8 |
| III. CORPORATE INFORMATION |
|
22 |
This Interim Report contains forward-looking statements
and estimates with respect to the anticipated future performance of MDxHealth SA and its wholly-owned subsidiaries (hereinafter “MDxHealth”
or the “Company”) and the market in which it operates. Such statements and estimates are based on assumptions and assessments
of known and unknown risks, uncertainties and other factors, which were deemed reasonable but may not prove to be correct. Actual events
are difficult to predict, may depend upon factors that are beyond the company’s control, and may turn out to be materially different.
Important factors that could cause actual results, conditions and events to differ materially from those indicated in the forward-looking
statements include, among others, the following: the Company’s plans relating to commercializing its tests and related diagnostic
products and services (collectively “tests”, “testing solutions” or “solutions”) and the rate and
degree of market acceptance of its solutions; the size of the market opportunity for the Company’s Confirm mdx, GPS mdx, and Exo
mdx tests and other future tests and solutions it may commercialize or develop; the acceptance of the Company’s testing solutions
by healthcare providers; the willingness of health insurance companies and other payers to cover the Company’s testing solutions
and adequately reimburse the Company for such solutions; changes in payer claims reimbursement practices and the Company’s estimates
regarding collection amounts for tests; the results of recoupment decisions and related appeals; the impacts and effectiveness of exiting
from discontinued operations; the Company’s plans relating to the further development of testing solutions; existing regulations
and regulatory developments in the United States, Europe and other jurisdictions; the Company’s ability to obtain and maintain regulatory
approvals and comply with applicable regulations; timing, progress and results of the Company’s research and development programs;
the period over which the Company estimates its existing cash will be sufficient to fund future operating expenses and capital expenditure
requirements; our ability to remain in compliance with financial covenants made to and make scheduled payments to our creditors; the Company’s
ability to cure any deficiencies in compliance with Nasdaq’s Minimum Bid Price and Market Value of Listed Securities requirements
or maintain compliance with other Nasdaq Listing Rules; the Company’s ability to attract and retain qualified employees and key
personnel; the scope of protection the Company is able to establish and maintain for intellectual property rights covering its testing
solutions and technology; the Company’s ability to operate its business without infringing the intellectual property rights and
proprietary technology of third parties; the possibility that the anticipated benefits from the Company’s business acquisitions
will not be realized in full or at all or may take longer to realize than expected; costs associated with defending intellectual property
infringement, product liability and other claims; and uncertainties associated with global macroeconomic conditions. The risks included
above are not exhaustive. Other important risks and uncertainties are described in the Risk Factors section of the 2025 Annual Report
on Form 20-F and under the heading “Principal risks related to the business activities” in “Section I. Interim Management
Report” below. You are further cautioned not to place undue reliance upon any such forward-looking statements, which speak only
as of the date made. MDxHealth expressly disclaims any obligation to update any such forward-looking statements in this Interim Report
to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement
is based unless required by law or regulation. This Interim Report does not constitute an offer or invitation for the sale or purchase
of securities or assets of MDxHealth in any jurisdiction. No securities of MDxHealth may be offered or sold within the United States without
registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any
applicable U.S. securities laws.
I. INTERIM MANAGEMENT REPORT
Highlights
Key non-audited financials, as of June 30,
2026
Key unaudited consolidated figures for continuing
operations for the six months ended June 30, 2026 and 2025 (thousands of U.S. dollars, except per share data):
| For the six months ended June 30, | |
2026 | | |
2025
(Re-presented*) | | |
$ Change | | |
% Change | |
| Revenue | |
| 51,106 | | |
| 44,957 | | |
| 6,149 | | |
| 14 | % |
| Gross Profit | |
| 32,559 | | |
| 30,519 | | |
| 2,040 | | |
| 7 | % |
| Operating expenses | |
| (45,822 | ) | |
| (36,735 | ) | |
| (9,087 | ) | |
| 25 | % |
| Operating loss | |
| (13,263 | ) | |
| (6,216 | ) | |
| (7,047 | ) | |
| 113 | % |
| Net loss from continuing operations | |
| (19,174 | ) | |
| (16,262 | ) | |
| (2,912 | ) | |
| 18 | % |
| Basic and diluted loss per share – continuing operations | |
| (0.37 | ) | |
| (0.33 | ) | |
| (0.04 | ) | |
| 12 | % |
| * | Comparative information has been re-presented to reflect
the classification of the Resolve business as a discontinued operation. Refer to Note 3 for further information. |
Revenue increased 14% to $51.1 million compared
to $45.0 million for the prior year. Revenue in the first six months of 2026 and 2025 was comprised 75% and 96% from tissue-based tests,
respectively.
Gross profit increased 7% to $32.6 million compared
to $30.5 million for the prior year. Gross margins were 63.7% as compared to 67.9% for the prior year, a reduction of 4.2 percentage points,
primarily attributed to test mix.
Operating loss increased 113% to $13.3 million
compared to $6.2 million for the prior year, driven by increased operating expenses related to the ExoDx acquisition in September 2025.
Net loss from continuing operations increased
18% to $19.2 million compared to $16.3 million for the prior year, primarily driven by higher operating expenses related to the ExoDx
acquisition in September 2025.
Justification to continue using the accounting
rules on the basis of going concern
The Company has experienced net losses and significant
cash used in operating activities since its inception in 2003, and as of and for the period ended June 30, 2026, had an accumulated deficit
of $423.4 million, a net loss of $20.4 million, and net cash used in operating activities of $7.3 million. Management expects the Company
to continue to incur net losses and have significant cash outflows for at least the next twelve months.
On August 13, 2026, the Company completed a registered
direct placement of 44,052,862 ordinary shares of the Company without nominal value (“Ordinary Shares”) at a price to the
public of $0.454 per Ordinary Share for total gross proceeds of $20 million.
While these conditions, among others, indicate
that a material uncertainty exists that casts substantial doubt about the Company’s ability to continue as a going concern, these
consolidated financial statements have been prepared assuming that the Company will continue as a going concern. This basis of accounting
contemplates the recovery of its assets and the satisfaction of liabilities in the normal course of business. A successful transition
to attaining profitable operations is dependent upon achieving a level of positive cash flows adequate to support the Company’s
cost structure.
As of June 30, 2026, the Company had cash and
cash equivalents of $19.2 million. Taking into account the above financial situation and on the basis of the most recent business plan,
including the Company’s expected ability to access additional cash through debt, equity, or other means, the Company believes that
it has sufficient cash to be able to continue its operations for at least the next twelve months from the date of issuance of these financial
statements, and accordingly has prepared the consolidated financial statements assuming that it will continue as a going concern. This
assessment is based on forecasts and projections within management’s most recent business plan as well as the Company’s expected
ability to maintain adequate levels of cash as required by certain financial covenants present in the OrbiMed Loan Facility, and to access
additional cash through debt, equity or other means, for which a material uncertainty exists that casts substantial doubt
on the Company’s ability to continue as a going concern.
Principal risks related to the business
activities
MDxHealth operates in a rapidly changing environment
that involves a number of risks that could materially affect its business, financial condition or future results, some of which are beyond
the Company’s control. In addition to the other information set forth in this section and elsewhere in this Interim Report, the
risks and uncertainties that the Company believes are most important for you to consider have been outlined in the 2025 Annual Report
on Form 20-F, which is available on the Securities and Exchange Commission’s website as well as the Company’s website at www.mdxhealth.com/investors/financials.
The Company’s failure to meet the
continued listing requirements of The Nasdaq Capital Market could result in a delisting of its securities.
Our ordinary shares are currently listed for trading
on Nasdaq. On June 30, 2026, we received a written notice from the Listing Qualifications Department of Nasdaq indicating that the Company
was not in compliance with the minimum bid price requirement set forth under Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”),
as the closing bid price of the Company’s ordinary shares was below $1.00 per share for 30 consecutive business days. Listing Rule
5550(a)(2) requires the registrant to maintain a minimum bid price of $1.00 per share for its securities listed on Nasdaq, and
Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum bid price requirement exists if the deficiency continues for a
period of 30 consecutive business days. Based on the closing bid price of the Company’s shares for the 30 consecutive business days
prior to that notice (May 15, 2026 through June 29, 2026), the Company did not meet the Minimum Bid Price Requirement.
Subsequently, on July 20, 2026, we received an
additional written notice from Nasdaq indicating that the Company is not in compliance with the minimum market value of listed securities
requirement set forth under Nasdaq Listing Rule 5550(b)(2) (the “MVLS Requirement”). Based on Nasdaq’s review of the
Company’s market value of listed securities for the 30 consecutive business days ended July 17, 2026, we did not meet
the MVLS Requirement. On August 28, 2026, Nasdaq confirmed in writing that the Company had regained compliance with the MVLS Requirement,
having maintained a market value of listed securities of $35 million or greater for 10 consecutive business days from August 14, 2026
to August 27, 2026, and that this matter was closed.
Pursuant to Nasdaq Listing Rules 5810(c)(3)(A),
we were provided 180 calendar days, or until December 28, 2026 to regain compliance with the Minimum Bid Price Requirement. To regain compliance with the Minimum Bid Price Requirement, the Company’s ordinary shares must
have a closing bid price of at least $1.00 per share for a minimum of 10 consecutive business days (or such longer period, up to 20 consecutive
business days, as Nasdaq may require).
If the Company does not regain compliance with
the Minimum Bid Price Requirement by December 28, 2026, the Company may be eligible for an additional 180-day compliance period,
provided that it meets all other initial listing standards for The Nasdaq Capital Market, other than the Minimum Bid Price Requirement,
and provides written notice of its intention to cure the deficiency. If the Company does not regain compliance with the Minimum Bid Price
Requirement following any applicable compliance period, Nasdaq will provide notice that the Company’s ordinary shares are subject
to delisting. In such event, the Company may appeal the delisting determination to a hearings panel.
The receipt of the notices has no immediate effect
on the listing of the Company’s ordinary shares, and the ordinary shares will continue to trade on Nasdaq under the symbol “MDXH”
during the applicable compliance periods. However, there can be no assurance that the Company will be successful in regaining or maintaining
compliance with the Nasdaq continued listing requirements. If the Company fails to regain compliance and its securities are delisted from
Nasdaq, such delisting could adversely affect the market liquidity of the Company’s ordinary shares, the ability of the Company
to raise capital, and the price at which the ordinary shares trade.
Declaration of responsible persons
The Board of Directors of MDxHealth SA, represented
by all its members, declares that, as far as it is aware, the financial statements in this Interim Report, made up according to the applicable
standards for financial statements, give a true and fair view of the equity, financial position and the results of the Company and its
consolidated subsidiaries. The Board of Directors of MDxHealth SA, represented by all its members, further declares that this Interim
Report gives a true and fair view on the information that has to be contained herein. The condensed consolidated interim financial statements
have been prepared in accordance with International Accounting Standard (IAS) 34 (Interim Financial Reporting) as issued by the International
Accounting Standards Board, or IASB, and as adopted by the EU.
II. INTERIM CONDENSED UNAUDITED CONSOLIDATED
FINANCIAL STATEMENTS OF MDXHEALTH SA
For the six months ended June 30, 2026
1. CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF PROFIT OR LOSS
AND OTHER COMPREHENSIVE INCOME
Thousands of $ (except per share data) For the six months ended June 30, | |
Note | |
2026 | | |
2025 (Re-presented*) | |
| –Continuing operations– | |
| |
| | | |
| | |
| Revenues | |
4 | |
| 51,106 | | |
| 44,957 | |
| Cost of sales (exclusive of amortization of intangible assets) | |
4 | |
| (18,547 | ) | |
| (14,438 | ) |
| Gross profit | |
| |
| 32,559 | | |
| 30,519 | |
| Research and development expenses | |
5 | |
| (4,129 | ) | |
| (4,347 | ) |
| Selling and marketing expenses | |
5 | |
| (22,804 | ) | |
| (17,816 | ) |
| General and administrative expenses | |
5 | |
| (16,235 | ) | |
| (11,899 | ) |
| Amortization of intangible assets | |
| |
| (2,513 | ) | |
| (2,626 | ) |
| Other operating expense, net | |
| |
| (141 | ) | |
| (47 | ) |
| Operating loss | |
| |
| (13,263 | ) | |
| (6,216 | ) |
| Financial income | |
6 | |
| 2,855 | | |
| 1,108 | |
| Financial expenses | |
6 | |
| (8,766 | ) | |
| (11,433 | ) |
| Loss before income tax | |
| |
| (19,174 | ) | |
| (16,541 | ) |
| Income tax (expense) benefit | |
| |
| - | | |
| 279 | |
| Loss from continuing operations | |
| |
| (19,174 | ) | |
| (16,262 | ) |
| –Discontinued operations– | |
| |
| | | |
| | |
| Loss from discontinued operations, net of tax | |
3 | |
| (1,225 | ) | |
| (319 | ) |
| Loss for the period attributable to owners of the parent | |
| |
| (20,399 | ) | |
| (16,581 | ) |
| | |
| |
| | | |
| | |
| Loss per share attributable to owners of the parent | |
| |
| | | |
| | |
| Basic and diluted loss per share from continuing operations | |
| |
| (0.37 | ) | |
| (0.33 | ) |
| Basic and diluted loss per share from discontinued operations | |
| |
| (0.03 | ) | |
| - | |
| Total basic and diluted loss per share | |
| |
| (0.40 | ) | |
| (0.33 | ) |
| | |
| |
| | | |
| | |
| Condensed unaudited consolidated statement of other comprehensive income | |
| |
| | | |
| | |
| | |
| |
| | | |
| | |
| Loss for the period attributable to owners of the parent | |
| |
| (20,399 | ) | |
| (16,581 | ) |
| Other comprehensive (loss) income | |
| |
| | | |
| | |
| Items that will be reclassified to profit or loss: | |
| |
| | | |
| | |
| Exchange differences arising from translation of foreign operations | |
| |
| 127 | | |
| (214 | ) |
| Total other comprehensive (loss) income attributable to the owners of the parent | |
| |
| 127 | | |
| (214 | ) |
| Total comprehensive loss for the period (net of tax) attributable to the owners of the parent | |
| |
| (20,272 | ) | |
| (16,795 | ) |
| * | Comparative information has been re-presented to reflect the
classification of the Resolve business as a discontinued operation. Refer to Note 3 for further information. |
2. CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF FINANCIAL POSITION
| Thousands of $ | |
Notes | |
as of June 30, 2026 | | |
as of December 31, 2025 | |
| ASSETS | |
| |
| | | |
| | |
| Non-current assets | |
| |
| | | |
| | |
| Goodwill | |
13 | |
| 39,252 | | |
| 38,948 | |
| Intangible assets | |
7 | |
| 36,709 | | |
| 39,424 | |
| Property, plant and equipment | |
8 | |
| 3,608 | | |
| 4,855 | |
| Right-of-use assets | |
| |
| 8,290 | | |
| 9,821 | |
| Financial assets | |
| |
| 1,199 | | |
| 1,496 | |
| Total non-current assets | |
| |
| 89,058 | | |
| 94,544 | |
| | |
| |
| | | |
| | |
| Current assets | |
| |
| | | |
| | |
| Assets held-for-sale | |
| |
| - | | |
| 940 | |
| Inventories | |
| |
| 6,433 | | |
| 6,741 | |
| Trade receivables | |
10 | |
| 14,926 | | |
| 14,675 | |
| Prepaid expenses and other current assets | |
| |
| 2,462 | | |
| 2,021 | |
| Cash and cash equivalents | |
| |
| 19,207 | | |
| 29,032 | |
| Total current assets | |
| |
| 43,028 | | |
| 53,409 | |
| TOTAL ASSETS | |
| |
| 132,086 | | |
| 147,953 | |
| | |
| |
| | | |
| | |
| EQUITY | |
| |
| | | |
| | |
| Share capital | |
| |
| 219,209 | | |
| 219,209 | |
| Issuance premium | |
| |
| 153,177 | | |
| 153,177 | |
| Accumulated deficit | |
| |
| (423,433 | ) | |
| (403,034 | ) |
| Share-based compensation | |
| |
| 21,297 | | |
| 19,335 | |
| Translation reserve | |
| |
| (654 | ) | |
| (781 | ) |
| Total equity | |
| |
| (30,404 | ) | |
| (12,094 | ) |
| | |
| |
| | | |
| | |
| LIABILITIES | |
| |
| | | |
| | |
| Non-current liabilities | |
| |
| | | |
| | |
| Loans and borrowings | |
9/10 | |
| 96,408 | | |
| 76,197 | |
| Lease liabilities | |
| |
| 7,634 | | |
| 8,509 | |
| Other non-current financial liabilities | |
9/10 | |
| 21,046 | | |
| 25,807 | |
| Total non-current liabilities | |
| |
| 125,088 | | |
| 110,513 | |
| | |
| |
| | | |
| | |
| Current liabilities | |
| |
| | | |
| | |
| Lease liabilities | |
| |
| 1,804 | | |
| 1,898 | |
| Trade payables | |
10 | |
| 10,569 | | |
| 10,330 | |
| Other current liabilities | |
| |
| 6,945 | | |
| 6,741 | |
| Other current financial liabilities | |
9/10 | |
| 18,084 | | |
| 30,565 | |
| Total current liabilities | |
| |
| 37,402 | | |
| 49,534 | |
| Total liabilities | |
| |
| 162,490 | | |
| 160,047 | |
| TOTAL EQUITY AND LIABILITIES | |
| |
| 132,086 | | |
| 147,953 | |
3. CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
Attributable to owners of MDxHealth SA
| Thousands of $, except number of shares | |
Number of
shares | | |
Share
capital
and
issuance
premium | | |
Accumulated
Deficit | | |
Share-based
compensation
and other
reserves | | |
Translation
reserves | | |
Total equity | |
| | |
| | |
| | |
| | |
Note 9, 12 | | |
| | |
| |
| Balance at December 31, 2024 | |
| 49,497,334 | | |
| 367,847 | | |
| (369,515 | ) | |
| 17,124 | | |
| (615 | ) | |
| 14,841 | |
| Loss for the period | |
| | | |
| | | |
| (16,581 | ) | |
| | | |
| | | |
| (16,581 | ) |
| Other comprehensive income | |
| | | |
| | | |
| | | |
| | | |
| (214 | ) | |
| (214 | ) |
| Total comprehensive (loss) for the period | |
| | | |
| | | |
| (16,581 | ) | |
| | | |
| (214 | ) | |
| (16,795 | ) |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Transactions with owners in their capacity as owners: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Share-based compensation | |
| | | |
| | | |
| | | |
| 1,071 | | |
| | | |
| 1,071 | |
| Balance at June 30, 2025 | |
| 49,497,334 | | |
| 367,847 | | |
| (386,096 | ) | |
| 18,195 | | |
| (829 | ) | |
| (883 | ) |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Balance at December 31, 2025 | |
| 51,364,520 | | |
| 372,386 | | |
| (403,034 | ) | |
| 19,335 | | |
| (781 | ) | |
| (12,094 | ) |
| Loss for the period | |
| | | |
| | | |
| (20,399 | ) | |
| | | |
| | | |
| (20,399 | ) |
| Other comprehensive income | |
| | | |
| | | |
| | | |
| | | |
| 127 | | |
| 127 | |
| Total comprehensive (loss) income for the period | |
| | | |
| | | |
| (20,399 | ) | |
| | | |
| 127 | | |
| (20,272 | ) |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Transactions with owners in their capacity as owners: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Share-based compensation | |
| | | |
| | | |
| | | |
| 1,167 | | |
| | | |
| 1,167 | |
| Exact Sciences 5-year warrants | |
| | | |
| | | |
| | | |
| 795 | | |
| | | |
| 795 | |
| Balance at June 30, 2026 | |
| 51,364,520 | | |
| 372,386 | | |
| (423,433 | ) | |
| 21,297 | | |
| (654 | ) | |
| (30,404 | ) |
4. CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF CASH FLOWS
Thousands of $ For the six months ended June 30, | |
Note | |
2026 | | |
2025 | |
| CASH FLOWS FROM OPERATING ACTIVITIES | |
| |
| | | |
| | |
| Operating loss | |
| |
| (14,425 | ) | |
| (6,504 | ) |
| Depreciation | |
| |
| 2,253 | | |
| 1,871 | |
| Amortization of intangible assets | |
| |
| 2,529 | | |
| 2,642 | |
| Impairment | |
3 | |
| 914 | | |
| - | |
| Provision for inventory obsolescence | |
3 | |
| 901 | | |
| 528 | |
| Share-based compensation | |
12 | |
| 1,167 | | |
| 1,071 | |
| Other non-cash transactions | |
| |
| (47 | ) | |
| 70 | |
| Cash used in operations before working capital changes | |
| |
| (6,708 | ) | |
| (322 | ) |
| | |
| |
| | | |
| | |
| Changes in operating assets and liabilities | |
| |
| | | |
| | |
| Increase (-) in inventories | |
| |
| (594 | ) | |
| (317 | ) |
| Increase (-) in receivables | |
| |
| (692 | ) | |
| (1,083 | ) |
| Increase (+) decrease (-) in payables | |
| |
| 654 | | |
| (2,507 | ) |
| Net cash outflow from operating activities | |
| |
| (7,340 | ) | |
| (4,229 | ) |
| | |
| |
| | | |
| | |
| CASH FLOWS FROM INVESTING ACTIVITIES | |
| |
| | | |
| | |
| Purchase of property, plant and equipment | |
8 | |
| (401 | ) | |
| (840 | ) |
| Payment of ExoDx purchase price adjustment | |
| |
| (304 | ) | |
| - | |
| Payment to Bio-Techne for share of Innovation Platform sale proceeds | |
| |
| (329 | ) | |
| - | |
| Earnout payment (GPS acquisition) | |
9/10 | |
| (7,479 | ) | |
| (19,658 | ) |
| Interest received | |
| |
| 354 | | |
| 922 | |
| Net cash outflow from investing activities | |
| |
| (8,159 | ) | |
| (19,576 | ) |
| | |
| |
| | | |
| | |
| CASH FLOWS FROM FINANCING ACTIVITIES | |
| |
| | | |
| | |
| Proceeds from loan obligation | |
9 | |
| 19,400 | | |
| 24,250 | |
| Earnout payment (GPS acquisition) | |
9/10 | |
| (6,521 | ) | |
| (8,313 | ) |
| Repayment of PPP loan obligation | |
9 | |
| - | | |
| (324 | ) |
| Payment of lease liability | |
| |
| (1,393 | ) | |
| (1,032 | ) |
| Payment of interest | |
| |
| (5,520 | ) | |
| (4,554 | ) |
| Other financial expense | |
| |
| (290 | ) | |
| (227 | ) |
| Net cash inflow from financing activities | |
| |
| 5,676 | | |
| 9,800 | |
| | |
| |
| | | |
| | |
| Net decrease in cash and cash equivalents | |
| |
| (9,823 | ) | |
| (14,005 | ) |
| | |
| |
| | | |
| | |
| Cash and cash equivalents at beginning of the period | |
| |
| 29,032 | | |
| 46,798 | |
| Effect of exchange rates | |
| |
| (2 | ) | |
| 18 | |
| Cash and cash equivalents at end of the period | |
| |
| 19,207 | | |
| 32,811 | |
5. EXPLANATORY NOTES
Accounting policies
When used in this report, all references to “mdxhealth”,
the “Company”, “we”, “our” and “us” refer to MDxHealth SA and its subsidiaries. MDxHealth
SA is a limited liability company domiciled in Belgium, with registered and corporate office at Cap Business Center, Rue d’Abhooz
31, 4040 Herstal, Belgium and labs in the United States.
Mdxhealth is a commercial-stage precision diagnostics
company committed to providing non-invasive, clinically actionable and cost-effective urologic solutions to improve patient care. The
Company’s novel prostate cancer genomic testing solutions combine advanced clinical modelling with genomic data to provide each
patient with a personalized cancer risk profile, which provides more accurate and actionable information than standard risk factors (e.g.,
PSA, DRE, age) used by clinicians.
The Company’s Confirm mdx and Exo mdx (formerly
ExoDx) solutions address men at risk for developing prostate cancer, providing physicians with a clear clinical pathway to accurately
identify clinically significant prostate cancer while minimizing the use of invasive procedures that are prone to complications. The Company’s
Genomic Prostate Score (GPS mdx) solution addresses men newly diagnosed with prostate cancer, providing physicians with a clear clinical
pathway to make the most informed treatment decision for their individual disease, including active surveillance. The Company’s
collective decades of experience in precision diagnostics and its portfolio of novel biomarkers for diagnostic, prognostic and predictive
molecular assays supports its active pipeline of new testing solutions for prostate and other urologic diseases.
In May 2026, the Company’s Board of Directors
approved a strategic plan to discontinue the Resolve UTI testing offering and cease operations at the Company’s laboratory facility
in Plano, Texas. As of June 30, 2026, the Company completed this wind-down with the permanent cessation of operations of its wholly-owned
subsidiary Delta Laboratories, LLC (“Delta Lab”) and its Plano, Texas laboratory. As a result, the Resolve UTI business has
been presented as discontinued operations in the consolidated financial statements. This requires the consolidated statement of profit
or loss for the six months ended June 30, 2026, to present continuing operations separately from discontinued operations, with comparative
amounts in the prior period re-presented on a consistent basis. The net cash flows of the discontinued operation are presented separately
in Note 3. There is no requirement for the re-presentation of the comparative consolidated statement of financial position as of December
31, 2025. For further information, refer to Note 3.
Mdxhealth offers its laboratory solutions from
its state-of-the-art College of American Pathologists (CAP)-accredited and Clinical Laboratory Improvement Amendments of 1988 (“CLIA”)
certified, molecular laboratory facility located at its U.S. headquarters in Irvine, California as well as a CLIA-certified lab in Waltham,
Massachusetts.
The condensed consolidated interim financial statements
have been prepared in accordance with International Accounting Standard (IAS) 34 – Interim Financial Reporting, as issued by the
International Accounting Standards Board, or IASB, and as adopted by the EU.
The principal accounting policies applied in the
preparation of the consolidated financial statements are set out below. These policies have been consistently applied to all the years
presented, unless otherwise stated. The functional and presentation currency is the U.S. Dollar ($) and all amounts are presented in thousands
of U.S. Dollars, rounded to the nearest thousand, unless otherwise indicated. The results and financial positions of foreign operations
that have a functional currency different from the presentation currency are translated into the presentation currency as follows:
| ● | Assets and liabilities for each statement of
financial position presented are translated at the closing rate at the date of that balance sheet. At June 30, 2026, the exchange rate
applied for assets and liabilities was €1 to $1.1394 (at December 31, 2025: €1 to $1.175) quoted by the European Central Bank. |
| ● | Income and expenses for each statement of profit
or loss and statement of comprehensive income are translated at average exchange rates. At June 30, 2026, the exchange rate applied for
income and expenses was €1 to $1.1666 (at June 30, 2025: €1 to $1.0927) quoted by the European Central Bank. |
| ● | All resulting exchange differences are recognized
in other comprehensive income. |
These interim consolidated financial statements
do not include all the information required for full annual financial statements and should be read in conjunction with the consolidated
financial statements of the Company as of, and for the year ended, December 31, 2025.
The Company ended the period with $19.2 million
in cash and cash equivalents as of June 30, 2026, and continued to incur losses. On August 13, 2026, the Company completed a registered
direct placement of 44,052,862 ordinary shares of the Company without nominal value (“Ordinary Shares”) at a price to the
public of $0.454 per Ordinary Share for total gross proceeds of $20 million. The Company is expecting continued losses and negative operating
cash flows in the coming twelve months. Taking into account the above financial situation and on the basis of the most recent business
plan, including the Company’s expected ability to access additional cash through debt, equity, or other means, the Company believes
that it has sufficient cash to be able to continue its operations for at least the next twelve months from the date of issuance of these
financial statements, and accordingly has prepared the consolidated financial statements assuming that it will continue as a going concern.
This assessment is based on forecasts and projections within management’s most recent business plan as well as the Company’s
expected ability to maintain adequate levels of cash as required by certain financial covenants present in the OrbiMed Loan Facility (described
in Note 9), and to access additional cash through debt, equity or other means, for which at this moment, a material uncertainty exists
that casts substantial doubt about the Company’s ability to continue as a going concern.
| 2. |
Significant accounting policies, use of judgments and estimates |
The financial statements comply with IFRS as issued
by the International Accounting Standards Board (IASB), collectively “IFRS”. In addition, the financial statements are also
prepared in accordance with IFRS as adopted by the EU (“EU IFRS”). The same accounting policies, presentation and methods
of computation have been followed in these condensed financial statements as were applied in the preparation of the Company’s financial
statements for the year ended December 31, 2025. No amendments to existing standards that became applicable as from January 1, 2026, have
a material impact on the interim condensed consolidated financial statements or accounting policies.
The preparation of the interim condensed financial
statements in compliance with IAS 34 requires the use of certain critical accounting estimates. It also requires the Company’s management
to exercise judgment in applying the Company’s accounting policies. The Company has applied the same accounting policies and methods
of computation in these interim condensed consolidated financial statements as those applied in its consolidated financial statements
for the year ended December 31, 2025, except for the changes in accounting estimates relating to the recognition of testing revenue described
below, which were adopted during the six-month period ended June 30, 2026, and applied prospectively in accordance with IAS 8.
The Company revised its estimate for cash collections
in excess of amounts accrued on an individual accession, which are now applied against accounts receivable rather than recognized as cash-basis
revenue. The Company also extended the period over which accounts receivable is carried before being aged out from nine to twelve months.
The combined effect of these changes was a decrease in testing revenue of approximately $0.2 million for the six months ended June 30,
2026. The effect of these changes in estimate on future periods has not been provided, as estimating that effect is impracticable.
Discontinued Operations
During the six months ended June 30, 2026, the
Company applied IFRS 5, Non-current Assets Held for Sale and Discontinued Operations to the strategic exit from the Resolve UTI
testing business and the closure of the Plano, Texas laboratory. This involved assessing the specific timeline of the operational shutdown
to determine when the business component was considered abandoned. Based on this assessment, the Resolve business met the criteria to
be classified as a discontinued operation as of the end of the interim reporting period. Consequently, the historical comparative periods
in the Condensed Consolidated Statement of Profit or Loss have been re-presented to reflect this classification. The net cash flows of
the discontinued operation are presented separately in Note 3. Further details are provided in Note 3.
| 3. |
Discontinued operations |
Discontinuation of the Resolve UTI Business
In May 2026, the Company’s Board of Directors
approved a strategic plan to discontinue the Resolve UTI testing offering and cease operations at the Company’s laboratory facility
in Plano, Texas. This proactive exit was initiated to prioritize the integration of the recently acquired ExoDx business and to focus
the Company’s capital, operational resources, and sales force on its core prostate cancer precision diagnostics menu.
The decision to exit the UTI testing market was
primarily driven by the increasingly uncertain administrative and reimbursement landscape for complex, multi-organism UTI testing. Specifically,
unexplained policy reversals and heightened reimbursement volatility from Novitas, the Medicare Administrative Contractor (MAC) overseeing
the Texas laboratory, made the continued operation of this business line unsustainable. The operational shutdown of the Plano facility
and the discontinuation of the Resolve offering were completed by June 30, 2026.
Financial Statement Presentation
In accordance with IFRS 5, Non-current Assets
Held for Sale and Discontinued Operations, the Resolve UTI business represents a separate major line of business and geographical
area of operations, and constitutes a component of the Company whose operations and cash flows are clearly distinguished, both operationally
and for financial reporting purposes, from the rest of the Company. Because the Resolve business was abandoned rather than sold, and its
carrying amount will not be recovered principally through a sale transaction, the disposal group does not qualify as held for sale under
IFRS 5.13. However, the complete cessation of the Resolve clinical operations and the permanent closure of the dedicated Plano, Texas
laboratory both occurred prior to June 30, 2026, satisfying the abandonment criteria within the interim period. Accordingly, the results
of the Resolve business are presented as a discontinued operation from the date on which it ceased to be used, and its net cash flows
are presented separately in this note, in accordance with IFRS 5.13 and IFRS 5.31–5.32.
The results of operations associated with the
Resolve business have been excluded from the Company’s continuing operations and are presented net of tax as a single line item,
“Loss from discontinued operations, net of tax,” in the Condensed Consolidated Statement of Profit or Loss. The net cash flows
from operating, investing, and financing activities of the discontinued operation are presented separately in this note.
To ensure comparability, the Unaudited Condensed
Consolidated Statement of Profit or Loss for the six months ended June 30, 2025, has been retroactively re-presented to reflect the Resolve
business as a discontinued operation. The net cash flows of the discontinued operation for the comparative period are presented separately
in this note. In accordance with IFRS 5, the comparative Condensed Consolidated Statement of Financial Position as of December 31, 2025,
has not been re-presented.
Thousands of $ (except per share data) For the six months ended June 30, | |
2026 | | |
2025 | |
| Results of discontinued operations | |
| | |
| |
| Revenues | |
| 5,651 | | |
| 5,940 | |
| Cost of sales (exclusive of amortization of intangible assets) | |
| (3,739 | ) | |
| (3,388 | ) |
| Gross Profit | |
| 1,912 | | |
| 2,552 | |
| Research and development expenses | |
| - | | |
| (719 | ) |
| Selling and marketing expenses | |
| (1,680 | ) | |
| (1,927 | ) |
| General and administrative expenses | |
| (464 | ) | |
| (178 | ) |
| Amortization of intangible assets | |
| (16 | ) | |
| (16 | ) |
| Other operating expense, net | |
| (914 | ) | |
| - | |
| Operating loss | |
| (1,162 | ) | |
| (288 | ) |
| Financial income | |
| 2 | | |
| 4 | |
| Financial expenses | |
| (65 | ) | |
| (35 | ) |
| Loss before income tax | |
| (1,225 | ) | |
| (319 | ) |
| Income tax benefit | |
| - | | |
| - | |
| Loss attributable to owners of the parent | |
| (1,225 | ) | |
| (319 | ) |
| Loss per share attributable to owners of the parent | |
| | | |
| | |
| Basic and diluted | |
| (0.03 | ) | |
| - | |
Thousands of $ For the six months ended June 30, | |
2026 | | |
2025 | |
| Results of discontinued operations | |
| | |
| |
| Net cash outflow from operating activities | |
| (1,263 | ) | |
| (744 | ) |
| Net cash outflow from investing activities | |
| (154 | ) | |
| (173 | ) |
| Net cash outflow from financing activities | |
| (194 | ) | |
| (179 | ) |
Exit charges and asset impairments
As part of the wind-down of the Resolve business,
the Company recognized the following charges within loss from discontinued operations for the six months ended June 30, 2026. Impairment
charges of $0.9 million were recognized, comprised of intangible assets of $0.2 million, property, plant and equipment of $0.3 million,
and the right-of-use asset associated with the Plano, Texas laboratory of $0.4 million, in each case recorded within other operating expense,
net, together with an inventory obsolescence provision of $0.9 million recorded within cost of sales. In addition, the loss from discontinued
operations includes employee severance and termination costs of $0.2 million recorded within cost of sales, and legal and professional
costs of $0.3 million recorded within general and administrative expenses. The lease liability associated with the Plano, Texas laboratory
remains recognized as of June 30, 2026 and will be derecognized upon deconsolidation of Delta Lab (see Note 14).
Contingencies related to the discontinued operation
On April 20, 2026, Delta Lab received a Medicare
contractor recoupment decision dated April 13, 2026, totaling approximately $10.4 million related to a retrospective review of certain
historical Resolve mdx claims. Delta Lab strongly disagrees with the contractor’s findings and is vigorously contesting the contractor’s
decision on substantive and procedural grounds. The Company has evaluated the matter and concluded that the recognition criteria for an
accrual have not been met. The existence and ultimate amount of any obligation are contingent on the outcomes of a multi-level appeals
process, which are uncertain future events not wholly within either Delta Lab’s or the Company’s control. At this time no reliable
estimate of any obligation can be made. Accordingly, the matter is accounted for as a contingent liability, and no provision has been
recorded in the Company’s interim financial statements for the six months ended June 30, 2026.
| 4. |
Revenue and cost of sales |
Revenue
Thousands of $ For the six months ended June 30, | |
2026 | | |
2025 (Re-presented*) | |
| Tissue-based revenue | |
| 38,086 | | |
| 43,180 | |
| Liquid-based revenue | |
| 12,847 | | |
| 1,762 | |
| Royalties and other revenues | |
| 173 | | |
| 15 | |
| Total revenue | |
| 51,106 | | |
| 44,957 | |
| * | Comparative information has been re-presented to reflect
the classification of the Resolve business as a discontinued operation. Refer to Note 3 for further information. |
The Company does not distinguish different business
segments since most revenues are generated from clinical laboratory service testing, or the out-licensing of the Company’s patented
DNA methylation platform and biomarkers. Revenue is generated primarily in the U.S. with minimal revenue recognized throughout Europe
and the rest of the world. The Company does distinguish between three sources of revenue:
| ● | Tissue-based revenue, from the Company’s
Confirm mdx and GPS mdx tests; |
| ● | Liquid-based revenue, from the Company’s
Exo mdx test (2026) and Select mdx and Germline test (2025); and |
| ● | Royalties and other revenues |
Revenues related to royalties, licenses and other
revenues are generally recognized over time as described in Note 2.7 of the Company’s 2025 year-end financial statements on Form
20-F. The Company did not recognize any contract assets or contracts liabilities.
Total revenue for six months ended June 30, 2026,
was $51.1 million, an increase of 14% as compared to total revenue of $45.0 million for the six months ended June 30, 2025, driven by
the acquisition of ExoDx in September 2025. Tissue-based tests (being GPS and Confirm mdx) comprised 75% and 96% of our six months ended
June 30, 2026, and 2025 revenues, respectively.
Cost
of sales (exclusive of amortization of intangible assets)
Thousands of $ For the six months ended June 30, | |
2026 | | |
2025 (Re-presented*) | |
| Cost of sales (exclusive of amortization of intangible assets) | |
| (18,547 | ) | |
| (14,438 | ) |
| Total cost sales | |
| (18,547 | ) | |
| (14,438 | ) |
| * | Comparative information has been re-presented to reflect
the classification of the Resolve business as a discontinued operation. Refer to Note 3 for further information. |
The costs of sales include the costs associated
with providing testing services to third parties and include the cost of materials, labor (including salaries, bonuses, and benefits),
transportation, collection kits, and allocated overhead costs associated with processing samples. Allocated overhead costs include depreciation
of laboratory equipment, facility occupancy and information technology costs. Costs associated with processing samples are expensed when
incurred, regardless of the timing of revenue recognition. Amortization of intangible assets are excluded from cost of sales and are presented
separately in the statement of profit or loss.
For further information relating to the primary
nature of the costs associated with each of our operating expenses categories, reference Note 5 in the 2025 20-F filing. The following
is a summary of the significant drivers of the changes affecting operating expenses.
Research & development expenses
For the six months ended June 30, 2026, research
and development expenses decreased 5%, primarily due to timing of our clinical research trials.
Sales and marketing expenses
For the six months ended June 30, 2026, selling
and marketing expenses increased by $5.0 million, or 28%, primarily due to the additional headcount related to the ExoDx acquisition which
was completed in September 2025.
General and administrative expenses
For the six months ended June 30, 2026, general
and administrative expenses increased by $4.3 million or 36%, primarily due to increased IT costs related to new AI initiatives as well
as increased HR and administrative costs related to the ExoDx acquisition.
Other operating expense, net
For the six months ended June 30, 2026, other
operating expense, net, was $0.1 million, primarily due to the write-off of fixed assets not associated with Delta Lab.
| 6. |
Financial income and expense |
Financial income
Thousands of $ For the six months ended June 30, | |
2026 | | |
2025 (Re-presented*) | |
| Interest income | |
| 352 | | |
| 918 | |
| Fair value adjustments | |
| | | |
| | |
| GPS contingent consideration | |
| 2,350 | | |
| - | |
| Right to pay ExoDx earnout in shares | |
| 153 | | |
| - | |
| Prepayment right on OrbiMed loan | |
| - | | |
| 190 | |
| Total financial income | |
| 2,855 | | |
| 1,108 | |
| * | Comparative information has been re-presented to reflect
the classification of the Resolve business as a discontinued operation. Refer to Note 3 for further information. |
Financial income for the period ended June 30,
2026, increased by $1.7 million, primarily attributed to the $2.4 million gain from fair value adjustments related to the GPS contingent
consideration, partially offset by a decrease of $0.6 million in interest income generated from our cash reserves. Refer to Note 9 for
details of the amendment to defer and extend the GPS earnout obligation.
Financial expenses
Thousands of $ For the six months ended June 30, | |
2026 | | |
2025 (Re-presented*) | |
| Contingent consideration fair value adjustments: | |
| | |
| |
| GPS contingent consideration | |
| - | | |
| (5,421 | ) |
| ExoDx contingent consideration | |
| (516 | ) | |
| - | |
| Innovation platform contingent liability | |
| (30 | ) | |
| - | |
| Prepayment right on OrbiMed loan | |
| (44 | ) | |
| - | |
| Exact Sciences warrants, net | |
| (795 | ) | |
| - | |
| NovioGendix contingent consideration | |
| - | | |
| (112 | ) |
| Right to pay GPS earnout in shares | |
| (407 | ) | |
| (292 | ) |
| Total fair value adjustments | |
| (1,792 | ) | |
| (5,825 | ) |
| | |
| | | |
| | |
| Other financial expenses: | |
| | | |
| | |
| Interest on OrbiMed loan | |
| (6,356 | ) | |
| (5,061 | ) |
| Interest on other loans & leases | |
| (347 | ) | |
| (340 | ) |
| Other financial loss | |
| (271 | ) | |
| (207 | ) |
| Total other financial expenses | |
| (6,974 | ) | |
| (5,608 | ) |
| Total financial expenses | |
| (8,766 | ) | |
| (11,433 | ) |
| * | Comparative information has been re-presented to reflect
the classification of the Resolve business as a discontinued operation. Refer to Note 3 for further information. |
Financial expenses for the period ended June 30,
2026, decreased by $2.7 million, primarily from a decrease of $5.4 million in the fair value of the GPS contingent consideration, partially
offset by an increase in $1.3 million in interest payments to OrbiMed as well as an increase of $0.8 million and $0.5 million in the fair
value of the Exact Sciences warrants and the ExoDx contingent consideration, respectively.
| Thousands of $ | |
Patents
and
software
licenses | | |
Internally-
developed
intangible
assets | | |
Externally
acquired
intellectual
property | | |
Customers | | |
Total | |
| Gross Value at January 1, 2025 | |
| 5,134 | | |
| 14,196 | | |
| 41,375 | | |
| 8,007 | | |
| 68,712 | |
| Additions | |
| | | |
| | | |
| | | |
| | | |
| | |
| Gross Value at June 30, 2025 | |
| 5,134 | | |
| 14,196 | | |
| 41,375 | | |
| 8,007 | | |
| 68,712 | |
| | |
| | | |
| | | |
| | | |
| | | |
| | |
| Accumulated amortization and impairment at January 1, 2025 | |
| (5,134 | ) | |
| (9,813 | ) | |
| (10,196 | ) | |
| (2,977 | ) | |
| (28,120 | ) |
| Additions | |
| - | | |
| (566 | ) | |
| (1,460 | ) | |
| (616 | ) | |
| (2,642 | ) |
| Accumulated amortization and impairment at June 30, 2025 | |
| (5,134 | ) | |
| (10,379 | ) | |
| (11,656 | ) | |
| (3,593 | ) | |
| (30,762 | ) |
| Net value at June 30, 2025 | |
| - | | |
| 3,817 | | |
| 29,719 | | |
| 4,414 | | |
| 37,950 | |
| Thousands of $ | |
Patents
and
software
licenses | | |
Internally-
developed
intangible
assets | | |
Externally
acquired
intellectual
property | | |
Customers | | |
Total | |
| Gross Value at January 1, 2026 | |
| 5,134 | | |
| 14,036 | | |
| 44,345 | | |
| 9,217 | | |
| 72,732 | |
| Additions | |
| - | | |
| | | |
| | | |
| | | |
| | |
| Disposals | |
| (3,687 | ) | |
| (2,156 | ) | |
| (4,825 | ) | |
| | | |
| (10,668 | ) |
| Gross Value at June 30, 2026 | |
| 1,447 | | |
| 11,880 | | |
| 39,520 | | |
| 9,217 | | |
| 62,064 | |
| | |
| | | |
| | | |
| | | |
| | | |
| | |
| Accumulated amortization and impairment at January 1, 2026 | |
| (5,134 | ) | |
| (10,904 | ) | |
| (13,007 | ) | |
| (4,263 | ) | |
| (33,308 | ) |
| Additions and impairments | |
| - | | |
| (487 | ) | |
| (2,137 | ) | |
| (92 | ) | |
| (2,529 | ) |
| Disposals | |
| 3,687 | | |
| 2,156 | | |
| 4,825 | | |
| | | |
| 10,481 | |
| Currency translation adjustments | |
| | | |
| | | |
| | | |
| 1 | | |
| 1 | |
| Accumulated amortization and impairment at June 30, 2026 | |
| (1,447 | ) | |
| (9,235 | ) | |
| (10,319 | ) | |
| (4,354 | ) | |
| (25,355 | ) |
| Net value at June 30, 2026 | |
| - | | |
| 2,645 | | |
| 29,201 | | |
| 4,863 | | |
| 36,709 | |
During the six months ended June 30, 2026, the
Company disposed of and impaired intangible assets it no longer utilizes, relating primarily to its European operations and the Select
mdx and Resolve product lines. The disposals consisted principally of fully amortized assets and had no material impact on the net carrying
amount; the related impairment charges were recognized in connection with the discontinued Resolve operation (see Note 3).
| 8. |
Property, plant & equipment |
During the six months ended June 30, 2026, the
Company acquired $0.4 million of fixed assets, consisting of $0.2 million of laboratory equipment, $0.1 million of leasehold improvements,
and $0.1 million of IT equipment and furniture, primarily to add testing capacity. During the same period, the Company disposed of and
impaired fixed assets of $0.7 million, primarily laboratory equipment no longer in use in connection with the discontinuation of Delta
Lab (see Note 3).
During the six-months ended June 30, 2025, the
Company acquired $0.8 million of fixed assets, which consisted of $0.6 million of laboratory equipment, $0.1 million of leasehold improvements,
and $0.1 million of IT equipment and furniture. The primary purpose of these acquisitions was to add testing capacity for GPS and Resolve
assays.
| 9. |
Loans, borrowings, lease obligations and other financial liabilities |
| | |
Loans and borrowings | | |
Other financial liabilities | |
thousands of $
As of | |
June 30, 2026 | | |
December 31, 2025 | | |
June 30, 2026 | | |
December 31, 2025 | |
| Beginning balance | |
| 76,197 | | |
| 51,291 | | |
| 56,372 | | |
| 67,856 | |
| Cash movements | |
| | | |
| | | |
| | | |
| | |
| Loans and borrowings repaid and contingent considerations (PPP / Exact Sciences / Innovation Platform) | |
| - | | |
| (324 | ) | |
| (14,329 | ) | |
| (27,971 | ) |
| Loans and borrowings received (OrbiMed) | |
| 20,000 | | |
| 25,000 | | |
| - | | |
| - | |
| Amendment and other fees related to OrbiMed agreement | |
| (625 | ) | |
| (871 | ) | |
| - | | |
| - | |
| Non-cash movements | |
| | | |
| | | |
| | | |
| | |
| Recognition of initial consideration for ExoDx acquisition | |
| - | | |
| - | | |
| - | | |
| 4,539 | |
| Recognition of ExoDx contingent consideration | |
| - | | |
| - | | |
| - | | |
| 6,273 | |
| Transfer of Innovation Platform to Exact Sciences applied against the GPS earnout payable (see Note 10) | |
| - | | |
| - | | |
| (1,000 | ) | |
| - | |
| Recognition and settlement of Innovation Platform contingent consideration | |
| - | | |
| - | | |
| (171 | ) | |
| 470 | |
| Recognition of warrants classified as liability | |
| - | | |
| | | |
| 3,856 | | |
| - | |
| Settlement of ExoDx obligation through issuance of shares | |
| - | | |
| - | | |
| - | | |
| (4,539 | ) |
| Reclass of warrants as an equity instrument | |
| - | | |
| - | | |
| (795 | ) | |
| - | |
| Effective interest rate adjustment (OrbiMed) | |
| 836 | | |
| 1,101 | | |
| - | | |
| - | |
| Fair value changes through profit and loss | |
| - | | |
| - | | |
| (4,803 | ) | |
| 9,744 | |
| Ending balance | |
| 96,408 | | |
| 76,197 | | |
| 39,130 | | |
| 56,372 | |
OrbiMed Credit Agreement
On May 1, 2024, the Company entered into a $100
million credit agreement (the “Credit Agreement”) with certain funds managed by OrbiMed Advisors LLC (“OrbiMed”).
The Credit Agreement provides a five-year senior secured credit facility in an aggregate principal amount of up to $100 million (the “Loan
Facility”), of which (i) $55 million was advanced on May 1, 2024, (ii) $25 million was advanced, on March 10, 2025, and (iii) $20
million was advanced on March 30, 2026. For further information relating to the OrbiMed Credit Agreement, refer to Note 16 in the 2025
20-F filing.
Other financial liabilities
GPS Contingent consideration
As part of the acquisition of the GPS business
from Exact Sciences in August 2022, and the subsequent amendments to the asset purchase agreement, an aggregate earnout amount of up to
$82.5 million was to be paid by the Company to Exact Sciences upon achievement of certain revenue milestones related to fiscal years 2023
through 2025.
On April 30, 2025, the Company made its first
earnout payment to Exact Sciences in the amount of $28.0 million, lowering the aggregate undiscounted amount due to Exact Sciences from
$82.5 million to $54.5 million.
On January 9, 2026, mdxhealth and Exact
Sciences signed an amendment to defer and extend the earnout obligation. Per the terms of the amendment, the remaining earnout
payments owed to Exact Sciences will be paid as follows: $15.0 million by April 15, 2026 (which the Company paid on April 15, 2026;
$14.0 million settled in cash and $1.0 million through transfer of the Innovation Platform), $18.0 million by April 15, 2027, and
$21.5 million by April 15, 2028. In consideration, mdxhealth agreed to issue to Exact Sciences warrants exercisable into 3 million
ordinary shares of mdxhealth at an exercise price of $5.265 per warrant.
The issuance of the warrants was subject to shareholder
approval. Pending that approval, the Company’s obligation to deliver the warrants was classified as a financial liability measured at
fair value through profit or loss, with an initial fair value of $3.9 million recognized in financial expenses. Following shareholder
approval at the Annual General Meeting in May 2026, the warrants qualified as equity instruments and the liability, with a then-current
fair value of $0.8 million, was reclassified to equity with no subsequent remeasurement. The net amount recognized in financial expenses
for the six months ended June 30, 2026 was $0.8 million, comprising the initial recognition of $3.9 million less subsequent fair value
gains of $3.1 million.
As of June 30, 2026, the contingent consideration
has been assessed at $31.8 million, of which $15.8 million has been recorded under “Other current financial liabilities” and
the remaining $16.0 million has been recorded under “Other non-current financial liabilities”. As of December 31, 2025, the
contingent consideration was assessed at $49.1 million, and has been accounted for as other financial liabilities (current and non-current
liabilities).
Exosome Contingent consideration
In connection with the acquisition of the Exosome
(ExoDx) business from Bio-Techne in September 2025, the Company agreed to make deferred contingent payments to Bio-Techne of up to $10.0
million. At the Company’s option, a portion of these payments may be settled in cash or through the issuance of shares of the Company,
subject to the limitation that no more than 50% of the earnout may be settled in shares. The contingent consideration is measured at fair
value through profit or loss.
As of June 30, 2026, the contingent consideration
was assessed at $7.3 million, of which $2.3 million has been recorded under “Other current financial liabilities” and the
remaining $5.0 million has been recorded under “Other non-current financial liabilities”. As of December 31, 2025, the contingent
consideration was assessed at $6.8 million, and has been accounted for as other financial liabilities (current and non-current liabilities).
| 10. |
Financial instruments and fair value |
The table shows the Company’s significant
financial assets and liabilities. All financial assets and liabilities are carried at amortized cost with the exception of the contingent
considerations in relation to acquisitions and derivative financial instruments reported at fair value through profit and loss.
All financial assets and liabilities are considered
to have carrying amounts that do not materially differ from their fair value.
The carrying value and fair value of the financial
instruments as of June 30, 2026, and December 31, 2025, can be presented as follows:
| Thousands of $ | |
As of June 30, 2026 | | |
As of December 31, 2025 | | |
Fair value hierarchy |
| Financial assets | |
| | |
| | |
|
| At fair value: | |
| | |
| | |
|
| Right to pay GPS earnout in shares | |
| 124 | | |
| 530 | | |
Level 3 |
| Right to pay ExoDx earnout in shares | |
| 386 | | |
| 233 | | |
Level 3 |
| Right for early repayment of OrbiMed loan | |
| 689 | | |
| 733 | | |
Level 3 |
| Subtotal financial assets at fair value | |
| 1,199 | | |
| 1,496 | | |
|
| | |
| | | |
| | | |
|
| At amortized cost: | |
| | | |
| | | |
|
| Trade receivables | |
| 14,926 | | |
| 14,675 | | |
|
| Cash and cash equivalents | |
| 19,207 | | |
| 29,032 | | |
|
| Subtotal financial assets at amortized cost | |
| 34,133 | | |
| 43,707 | | |
|
| Total financial assets | |
| 35,332 | | |
| 45,203 | | |
|
| | |
| | | |
| | | |
|
| Financial liabilities | |
| | | |
| | | |
|
| At fair value: | |
| | | |
| | | |
|
| Other financial liabilities | |
| | | |
| | | |
|
| GPS contingent consideration | |
| 31,850 | | |
| 49,139 | | |
Level 3 |
| Exosome contingent consideration | |
| 7,280 | | |
| 6,763 | | |
Level 3 |
| Innovation platform contingent consideration | |
| - | | |
| 470 | | |
Level 3 |
| Subtotal financial liabilities at fair value | |
| 39,130 | | |
| 56,372 | | |
|
| | |
| | | |
| | | |
|
| At amortized cost: | |
| | | |
| | | |
|
| Loans and borrowings | |
| 96,408 | | |
| 76,197 | | |
Level 2 |
| Lease liabilities | |
| 9,438 | | |
| 10,407 | | |
|
| Trade payables | |
| 10,569 | | |
| 10,330 | | |
|
| Subtotal financial liabilities at amortized cost | |
| 116,415 | | |
| 96,934 | | |
|
| Total financial liabilities | |
| 155,545 | | |
| 153,306 | | |
|
The fair value of the financial instruments has
been determined on the basis of the following methods and assumptions:
| ● | The carrying value of the cash and cash equivalents,
the trade receivables, other current assets and the trade payables approximate their fair value due to their short-term character. |
| ● | The fair value of loans and borrowings applying
the effective interest rate method approximates their carrying value (level 2). |
| o | OrbiMed Loan Facility: the host financial liability was obtained with a variable interest rate
based upon the Secured Overnight Financing Rate (“SOFR”), (with a floor of 2.5%) plus a margin of 8.5%. |
| ● | Leases are measured at the present value of the
remaining lease payments, using a discount rate based on the incremental borrowing rate at the commencement date of these leases. Their
fair value approximates their carrying value. |
| ● | The fair value of contingent consideration payable
to Bio-Techne (for the ExoDx acquisition) and Exact Sciences (for the GPS acquisition) is based on an estimated outcome of the conditional
purchase price/contingent payments arising from contractual obligations (level 3). This is initially recognized as part of the purchase
price and subsequently fair valued with changes recorded through financial income/expense in the statement of profit or loss. |
| o | ExoDx: the fair value of the contingent consideration payable to Bio-Techne is based on the net
present value of the expected future payments, which are payable in equal annual installments over four years, subject to certain conditions.
This contingent consideration was initially recorded along with the purchase price allocation of this business combination on September
15, 2025. Fair-value adjustments resulting in total charges of $0.5 million have been recorded in financial expenses for the period ended
June 30, 2026. The Company used a discount rate of 17.99%. A hypothetical 1.5% increase (decrease) in the discount rate would correspond
to a decrease (increase) in the fair value by approximately -$0.1 million (+$0.1 million), assuming all other variables remain constant. |
| o | GPS: the fair value of the contingent consideration payable to Exact Sciences is based on the estimated
net present value of the remaining earnout payment of $39.5 million. This contingent consideration was initially recorded along with the
purchase price allocation of this business combination. Fair-value adjustments resulting in total financial gains of $2.4 million have
been recorded as of June 30, 2026, of which the full amount has been included in financial income. The Company used a discount rate of
17.99%. A hypothetical 1.5% increase (decrease) in the discount rate would correspond to a decrease (increase) in the fair value by approximately
-$0.5 million (+$0.5 million), assuming all other variables remain constant. |
| ● | Derivative Financial assets, both valued using
valuation models with level 3 inputs: |
| o | The fair value of the Company’s option to prepay the OrbiMed Loan Facility was measured based on
a valuation model which takes into account several factors, including the expected prepayment option exercise price and the potential
cash savings that could be realized by the Company. This valuation model is considered as level 3 input and was valued as a $0.7 million
financial asset, as of June 30, 2026. |
| o | The fair value of Company’s option to settle the Exact Sciences earnout obligation in cash or through
the issuance of additional shares of the Company was measured based on a Monte Carlo valuation model which takes into account several
factors including the expected evolution in Company’s share price as well as the 7.5% ownership limit of the outstanding shares
of mdxhealth, as described above. This valuation model is considered as level 3 input and was valued as a $0.1 million financial asset,
as of June 30, 2026. |
| o | The fair value of the Company’s option to settle the Exosome earnout obligation in cash or through
the issuance of additional shares of the Company was measured based on a Monte Carlo valuation model which takes into account several
factors including the expected evolution in Company’s share price as well as the limitation that a maximum of 50% of the $10.0 million
Exosome earnout may be settled through the issuance of shares of mdxhealth, as described above. This valuation model is considered as
level 3 input and was valued as a $0.4 million financial asset, as of June 30, 2026. |
No financial assets or financial liabilities have been reclassified
between the valuation categories during the year.
A reconciliation of cash and non-cash movements
of level 3 financial liabilities is presented in the table in Note 9 under the heading “Other financial liabilities”.
| 11. |
Related party transactions |
There were no transactions to key management other
than remuneration, warrants, and bonus, all of which are detailed in the Company’s 2025 Annual Report. For the six months ended
June 30, 2026, total remuneration for key management and Directors was $2.0 million, and 1.7 million warrants were granted.
There were no other related party transactions.
During the second quarter of 2026, the shareholders
approved the issuance of 3,000,000 Share Options, pursuant to a share option plan named the “2026 Share Option Plan” in an
effort to create a pool of outstanding options available for further grants to selected participants. Each 2026 Share option shall entitle
the holder thereof to subscribe for one new share to be issued by the Company. As of June 30, 2026, 1,562,300 shares from the 2026 Share
Option Plan were granted.
As of June 30, 2026, there are 7,523,991 employee
warrants outstanding, entitling their holders to subscribe to 7,523,991 shares of the Company. As of June 30, 2026, there are 2,939,892
vested warrants outstanding.
The warrants have been granted free of charge.
Each warrant entitles its holder to subscribe to one common share of the Company at a subscription price determined by the board of directors,
within the limits decided upon at the time of their issuance. The warrants issued generally have a term of ten years as of issuance. Upon
expiration of their term, the warrants become null and void. In general, the warrants vest in cumulative tranches of 25% per year, provided
that the beneficiary has been employed for at least one year.
All warrant grants are considered to be equity-settled,
share-based payment plans where the fair value of the warrants granted is determined at the grant date, without subsequent remeasurement.
The fair value of each warrant grant is estimated using the Black-Scholes option pricing model with the following assumptions:
| ● | The dividend return is estimated by reference
to the historical dividend payment of the Company; currently, this is estimated to be zero as no dividends have been paid since inception. |
| ● | The expected volatility was determined using
the Euronext average volatility of the stock over the last two years at the date of grant for any grants done until December 15, 2023,
the date on which the delisting from Euronext took place. For any subsequent grants, the expected volatility was determined using the
Nasdaq Capital Market average volatility of the stock over the last two years at the date of grant. |
| ● | For grants done until December 15, 2023, the
risk-free interest rate was based on the interest rate applicable for the 10-year Belgian government bond at the grant date. For grants
performed after December 15, 2023, the risk-free rate was based on the 10-year risk free treasury par yield curve rates listed by the
U.S. Department of the Treasury. |
The model inputs for warrants granted during the period ended June
30, 2026, included:
| Grant Date | |
Number of Shares | | |
Exercise Plan | | |
Expiry Date | |
Stock Price | | |
Exercise Price | | |
Expected Dividend Yield | | |
Expected Volatility | | |
Risk Free Rate | |
| January 1, 2026 | |
| 1,000 | | |
| 2025 | | |
31/03/2035 | |
$ | 3.57 | | |
$ | 3.57 | | |
| - | | |
| 82.67 | % | |
| 4.18 | % |
| March 5, 2026 | |
| 1,500 | | |
| 2025 | | |
31/03/2035 | |
$ | 3.31 | | |
$ | 3.42 | | |
| - | | |
| 82.47 | % | |
| 4.13 | % |
| June 1, 2026 | |
| 201,500 | | |
| 2025 | | |
31/03/2035 | |
$ | 0.66 | | |
$ | 0.76 | | |
| - | | |
| 91.83 | % | |
| 4.47 | % |
| June 1, 2026 | |
| 1,562,300 | | |
| 2026 | | |
31/03/2036 | |
$ | 0.66 | | |
$ | 0.76 | | |
| - | | |
| 91.83 | % | |
| 4.47 | % |
The total fair value of the granted warrants during
the six months ended June 30, 2026, is estimated at $0.9 million following the underlying assumptions of the model. This amount represents
the full fair value of the warrants granted in 2026 that will vest over time. For the six months ended, June 30, 2026, the company recorded
an expense of $1.2 million.
13. Goodwill impairment testing
The goodwill amount of $39.3 million as of June
30, 2026 is fully allocated to the Company’s single cash-generating unit (“CGU”), corresponding to the Company as a whole. The
Company does not distinguish separate business segments or smaller groups of assets that generate largely independent cash inflows.
During the period, the Company recognized a measurement-period
adjustment of $0.3 million to goodwill in connection with the finalization of the ExoDx working capital adjustment.
Impairment indicator
The decision of the Board to discontinue the Resolve
UTI business, and the subsequent significant decline of the Company’s share price in the period thereafter, are triggers for an
impairment test. As a result (although goodwill is otherwise tested for impairment on an annual basis) management performed an interim
impairment assessment as of June 30, 2026.
The recoverable amount of the CGU has been determined
from the value-in-use calculation based on the Company’s updated cash flow projections covering a period of 4.5 years through December
31, 2030. The use of this method requires estimating of future cash flows and the determination of a discount rate in order to calculate
the present value of the cash flows.
The amount by which the CGU’s recoverable
value exceeds its carrying value is $134.3 million, following a number of refinements of the model as well as updated estimates on the
budgeted cashflows after the exclusion from the Resolve test.
The main assumptions used are as follows:
| For the Years Ended December 31 | |
June 30,
2026 | | |
December 31,
2025 | |
| Discount rate (post-tax) | |
| 18.81 | % | |
| 18.64 | % |
| Terminal growth rate | |
| 2.0 | % | |
| 2.0 | % |
The discount rate is based on comparable companies
in the industry together with Company-specific risks. Terminal growth rate is based on management estimates and industry data.
The Company’s impairment review is not sensitive
to any reasonable possible changes in the key assumptions used by management.
Based on the above information, management concluded
that there was no Goodwill impairment on June 30, 2026.
On August 3, 2026, in connection with the permanent
cessation of operations of the Company’s wholly-owned subsidiary Delta Lab and its Plano, Texas laboratory, Delta Lab executed an Assignment
for the Benefit of Creditors (“ABC”) under applicable state law, assigning substantially all of its assets to an assignee for
the benefit of Delta Lab’s creditors. The assignee has broad authority to take possession of, preserve, and dispose of Delta Lab’s assets
and to administer creditor claims in accordance with statutory priorities. The ABC was undertaken to effect an orderly disposition of
Delta Lab’s assets and satisfaction of its claims, inclusive of the previously disclosed Novitas Solutions recoupment claim of $10.4 million
relating to certain historical Resolve mdx claims (see Note 3).
As a result of the ABC, control of Delta Lab passed
to the assignee, and the Company ceased to control Delta Lab within the meaning of IFRS 10. Accordingly, Delta Lab will be deconsolidated
from the Company’s consolidated financial statements in the third quarter of 2026, with the assets and liabilities of Delta Lab derecognized
as of the date control was lost. The ABC process is limited to Delta Lab, which has operated as a separate legal entity since its acquisition
in 2022. The deconsolidation is expected to result in a non-cash gain, presented within discontinued operations.
On August 13, 2026, the Company completed a registered
direct placement of 44,052,862 ordinary shares of the Company without nominal value (“Ordinary Shares”) at a price to the public
of $0.454 per Ordinary Share for total gross proceeds of $20 million before deducting estimated offering expenses. The shares were sold
to institutional investors and were placed directly by the Company under its shelf registration statement on Form F-3 filed on February
17, 2026. As the placement occurred after June 30, 2026, the newly issued shares are not included in the weighted-average number of shares
used to calculate earnings per share for the periods presented herein.
Subsequent to June 30, 2026, the Company received notices from Nasdaq regarding non-compliance with the minimum bid price and minimum
market value of listed securities requirements for continued listing on The Nasdaq Capital Market, as further described in ‘Principal
risks related to the business activities’ in the Interim Management Report. On August 28, 2026, Nasdaq confirmed in writing that
the Company had regained compliance with the minimum market value of listed securities requirement under Nasdaq Listing Rule 5550(b)(2),
having maintained a market value of listed securities of $35 million or greater for 10 consecutive business days from August 14 to August
27, 2026, and that this matter was closed. The Company remains in non-compliance with the separate minimum bid price requirement under
Nasdaq Listing Rule 5550(a)(2), for which the initial period to regain compliance extends to December 28, 2026.
III. CORPORATE INFORMATION
Registered office
MDxHealth SA has the legal form of a public limited
liability company (société anonyme - SA / naamloze vennootschap - NV) organized and existing under the laws of Belgium.
The company’s registered office is located at CAP Business Center, Rue d’Abhooz 31, B-4040 Herstal, Belgium.
The company is registered with the Registry of
Legal Persons (registre des personnes morales - RPM / rechtspersonenregister – RPR) under company number RPM/RPR 0479.292.440 (Liège).
Listings
NASDAQ: MDXH
Financial year
The financial year starts on 1 January and ends on 31 December.
Statutory auditor
BDO Bedrijfsrevisoren / Réviseurs d’entreprises BV/SRL
Da Vincilaan 9
1935 Zaventem
Belgium
Availability of the Interim Report
This document is available to the public free of charge and upon request:
MDxHealth SA – Investor Relations
CAP Business Center - Rue d’Abhooz, 31 – 4040 Herstal –
Belgium
E-mail: ir@mdxhealth.com
For informational purposes, an electronic version
of the 2026 Interim Report is available on the website of mdxhealth at www.mdxhealth.com/investors/financials