UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
Current Report
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Item 2.02 Results of Operations and Financial Condition.
On August 10, 2026, Insight Molecular Diagnostics Inc. (“we,” “us,” “our,” the “Company” or “iMDx”) issued a press release announcing our financial results for the three and six months ended June 30, 2026. A copy of the press release is furnished as Exhibit 99.1, which, in its entirety, is incorporated herein by reference.
The information in this Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1 hereto, 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. Such information shall not be deemed incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as otherwise expressly set forth by specific reference in such filing.
Item 7.01 Regulation FD Disclosure.
On August 10, 2026, the Company announced that it had received an Additional Information Request (“AIR”) from the FDA regarding its submission for GraftAssureDx, to which the Company must provide a complete response within 180 days. The Company believes the AIR is a routine part of the FDA submission process and is prepared to provide its complete response to the AIR. The Company expects to have one more meeting with the FDA before the fourth quarter of this year.
The information in this Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1 hereto, 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. Such information shall not be deemed incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as otherwise expressly set forth by specific reference in such filing.
Item 8.01 Other Events.
The information provided in “Item 7.01 - Regulation FD Disclosure” of this Current Report on Form 8-K is incorporated by reference into this Item 8.01.
Cautionary Note Regarding Forward-Looking Statements
Certain statements in this Current Report on Form 8-K may be considered “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements other than statements of historical fact contained in this Current Report. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon assumptions that, while considered reasonable by the Company and its management, are inherently uncertain. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date they were made or to reflect the occurrence of unanticipated events.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit Number | Description | |
| 99.1 | Press Release dated August 10, 2026 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| INSIGHT MOLECULAR DIAGNOSTICS INC. | ||
| Date: August 10, 2026 | By: | /s/ Peter Hong |
| Name: | Peter Hong | |
| Title: | Vice President, General Counsel | |