MDxHealth SA 6-K, filed Feb 15, 2023
MDxHealth SA (MDXH)
About this 6-K
MDxHealth SA filed this 6-K on February 15, 2023.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE
SECURITIES EXCHANGE ACT OF 1934
For the month of February 2023
Commission File Number 001-40996
MDXHEALTH SA
(Translation of registrant’s name into English)
CAP Business Center
Zone Industrielle des Hauts-Sarts
4040 Herstal, Belgium
+32 4 257 70 21
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):☐
Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant’s “home country”), or under the rules of the home country exchange on which the registrant’s securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant’s security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.
MDXHEALTH SA
On February 13 and February 15, 2023, MDxHealth SA (the “Company”) issued press releases, copies of which are attached hereto as Exhibits 99.1 and 99.2, respectively.
The information in the attached Exhibits 99.1 and 99.2 is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise set forth herein or as shall be expressly set forth by specific reference in such a filing.
| Exhibit No. | Description of Exhibit | |
| 99.1 | Press Release, dated February 13, 2023 | |
| 99.2 | Press Release, dated February 15, 2023 |
1
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| MDXHEALTH SA | ||
| Date: February 15, 2023 | By: | /s/ Michael McGarrity |
|
Name: Michael McGarrity Title: Chief Executive Officer | ||
2
Exhibit 99.1
NEWS RELEASE
13 FEBRUARY 2023, 4:00PM ET / 22:00 CET
MDxHealth Announces UnitedHealthcare to Provide Commercial Coverage for the Genomic Prostate Score (GPS) Test
UnitedHealthcare singles out mdxheath’s GPS test as its only commercially-covered test
to risk stratify men newly diagnosed with localized prostate cancer
IRVINE, CA, and HERSTAL, BELGIUM – February 13, 2023 – MDxHealth SA (NASDAQ/Euronext: MDXH), a commercial-stage precision diagnostics company, today announced that UnitedHealthcare will cover the mdxhealth Genomic Prostate Score (GPS) test (formerly Oncotype DX GPS) under UnitedHealthcare’s commercial policies to assist with treatment decisions for individuals newly diagnosed with localized prostate cancer and meeting coverage criteria.
Michael K. McGarrity, CEO of mdxhealth, commented: “We are very pleased to announce that UnitedHealthcare, the largest private health insurer in the United States, will provide coverage for our Genomic Prostate Score (GPS) test. We applaud UnitedHealthcare’s decision to identify our GPS test as its only commercially-covered diagnostic that can improve clinical outcomes for men newly diagnosed with localized prostate cancer.”
In its technical assessment of commercially available genomic panels for stratifying risk in individuals with prostate cancer, UnitedHealthcare’s updated Medical Policy cites findings that "the body of evidence consistently favors use of the GPS assay to assist with management strategies…” UnitedHealthcare’s commercial coverage of GPS supplements coverage that GPS has from other national and regional commercial payers, as well as from Medicare and Medicare Advantage plans.
About Genomic Prostate Score® (GPS) Test
The GPS test is an advanced 17-gene mRNA test to help guide treatment decisions for localized prostate cancer. The test analyzes prostate cancer gene activity to predict disease aggressiveness and provide clinically meaningful endpoints. GPS is a highly personalized assay that quantifies the biologic aggressiveness of the tumor using a 17-gene signature that includes 12 cancer-related genes representative of 4 key biological pathways and 5 reference genes. GPS predicts the likelihood of adverse pathology, prostate cancer death, and metastasis within 10 years.
About mdxhealth®
Mdxhealth is a commercial-stage precision diagnostics company that provides actionable molecular information to personalize patient diagnosis and treatment. The Company’s tests are based on proprietary genomic, epigenetic (methylation) and other molecular technologies and assist physicians with the diagnosis and prognosis of urologic cancers and other urologic diseases. The Company’s U.S. headquarters and laboratory operations are in Irvine, California, with additional laboratory operations in Plano, Texas. European headquarters are in Herstal, Belgium, with laboratory operations in Nijmegen, The Netherlands. For more information, visit mdxhealth.com and follow us on social media at:
twitter.com/mdxhealth, facebook.com/mdxhealth and linkedin.com/company/mdxhealth.
For more information:
|
mdxhealth info@mdxhealth.com |
|
|
LifeSci Advisors (IR & PR) US: +1 949 271 9223 ir@mdxhealth.com |
Forward-looking statements
This press release contains forward-looking statements and estimates with respect to the anticipated future performance of MDxHealth and the market in which it operates, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as “potential,” “expect,” “will,” “goal,” “next,” “potential,” “aim,” “explore,” “forward,” “future,” and “believes” as well as similar expressions. Forward-looking statements contained in this release include, but are not limited to, statements regarding the acquisition of Oncotype DX® GPS prostate cancer business from Exact Sciences including statements regarding the anticipated benefits of the acquisition; statements regarding expected future operating results; statements regarding product development efforts; and statements regarding our strategies, positioning, resources, capabilities and expectations for future events or performance. 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. Examples of forward-looking statements include, among others, statements we make regarding expected future operating results, product development efforts, our strategies, positioning, resources, capabilities and expectations for future events or performance. 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: uncertainties associated with the coronavirus (COVID-19) pandemic, including its possible effects on our operations, and the demand for our products; our ability to successfully and profitably market our products; the acceptance of our products and services by healthcare providers; the willingness of health insurance companies and other payers to cover our products and services and adequately reimburse us for such products and services; our ability to obtain and maintain regulatory approvals and comply with applicable regulations; the possibility that the anticipated benefits from our business acquisitions like our acquisition of the Oncotype DX® GPS prostate cancer business will not be realized in full or at all or may take longer to realize than expected; and the amount and nature of competition for our products and services. Other important risks and uncertainties are described in the Risk Factors sections of our most recent Annual Report on Form 20-F and in our other reports filed with the Securities and Exchange Commission. MDxHealth expressly disclaims any obligation to update any such forward-looking statements in this release 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 press release 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.
NOTE: The mdxhealth logo, mdxhealth, Confirm mdx, Select mdx, Resolve mdx, Genomic Prostate Score, GPS and Monitor mdx are trademarks or registered trademarks of MDxHealth SA. The GPS test was formerly known as and is frequently referenced in guidelines, coverage policies, reimbursement decisions, manuscripts and other literature as Oncotype DX Prostate, Oncotype DX GPS, Oncotype DX Genomic Prostate Score, and Oncotype Dx Prostate Cancer Assay, among others. The Oncotype DX trademark, and all other trademarks and service marks, are the property of their respective owners.
Exhibit 99.2
NEWS RELEASE –
REGULATED INFORMATION
FEBRUARY 15, 2023, 4:30 pm ET/ 22:30 CET
MDxHealth Announces
Update of Outstanding Shares and Voting Rights
and Update of Financial Calendar
IRVINE, CA, and HERSTAL, BELGIUM – February 15, 2023 – MDxHealth SA (NASDAQ/Euronext: MDXH) (“mdxhealth” or the “Company“), a commercial-stage precision diagnostics company, today announced, in accordance with Article 15 of the Belgian Act of May 2, 2007 on the disclosure of major participations in issuers of which shares are admitted to trading on a regulated market and regarding miscellaneous provisions, that in the context of the capital increase that was announced on February 1, 2023 and completed on February 7, 2023, its share capital has increased from EUR 123,539,165.19 to EUR 160,658,690.06, and the number of issued and outstanding shares has increased from 162,880,936 to 262,880,936 ordinary shares, through the issuance of a total of 100,000,000 new shares.
In addition to the outstanding shares of the Company:
| ● | a total of 13,895,280 subscription rights of the Company is outstanding, which entitles their holders (assuming all subscription rights are granted and exercised) to subscribe to a total of 13,895,280 new shares with voting rights; |
| ● | under the loan agreement entered into by the Company and Kreos Capital in July 2021, a drawdown fee equal to 7% of the amounts drawn down under the loan agreement (being EUR 630,000 in aggregate) remains outstanding as a payable due by the Company (without accruing interest), and is convertible into ordinary shares with voting rights by means of a contribution in kind of the payable by Kreos Capital to the share capital of the Company at a price of EUR 0.85 per share; and |
| ● | under the loan and security agreement entered into by the Company and Innovatus Capital Partners in August 2022, Innovatus has the right to convert, prior to August 2, 2025, up to 15% of the outstanding principal amount of the loans (by means of a contribution in kind of the relevant payables due by the Company under the loans) into American Depositary Shares ("ADSs") of the Company (each representing 10 ordinary shares of the Company) at a conversion price per ADS equal to USD 11.21 (i.e., USD 1.121 per share on the basis of the ratio of 1 ADS per 10 shares). |
Update of the 2023 Reporting Calendar
In addition, the Company announces that its financial calendar for 2023 shall be as follows:
| ● | March 8, 2023: 2022 FY results |
| ● | May 10, 2023: Q1-2023 business update |
| ● | May 25, 2023: Annual general shareholders' meeting |
| ● | August 23, 2023: Publication of H1-2023 results |
| ● | November 8, 2023: Q3-2023 business update |
About mdxhealth®
Mdxhealth is a commercial-stage precision diagnostics company that provides actionable molecular information to personalize patient diagnosis and treatment. The Company’s tests are based on proprietary genomic, epigenetic (methylation) and other molecular technologies and assist physicians with the diagnosis and prognosis of urologic cancers and other urologic diseases. The Company’s U.S. headquarters and laboratory operations are in Irvine, California, with additional laboratory operations in Plano, Texas. European headquarters are in Herstal, Belgium, with laboratory operations in Nijmegen, The Netherlands. For more information, visit mdxhealth.com and follow us on social media at: twitter.com/mdxhealth, facebook.com/mdxhealth and linkedin.com/company/mdxhealth.
For more information:
mdxhealth
info@mdxhealth.com
LifeSci Advisors (IR & PR)
US: +1 949 271 9223
ir@mdxhealth.com
NOTE: The mdxhealth logo, mdxhealth, Confirm mdx, Select mdx, Resolve mdx, Genomic Prostate Score, GPS and Monitor mdx are trademarks or registered trademarks of MDxHealth SA. All other trademarks and service marks are the property of their respective owners.