EX-99.1 2 ex99-1.htm EX-99.1 Exhibit 99.1 IMDX Reports Second Quarter 2026 Results and Timely Progress on FDA Review of GraftAssureDx Discussions with FDA advance toward expected marketing authorization for GraftAssureDx FDA completes current portion of substantive review in a timely manner Favorable Medicare reimbursement policy issued in July significantly increases GraftAssureDx surveillance testing opportunity Strong head-to-head data drive kitted customer interest NASHVILLE, TN., August 10, 2026 - Insight Molecular Diagnostics Inc., iMDx, (Nasdaq: IMDX), today published the following letter to shareholders in conjunction with its first quarter results: Fellow shareholders, We continue to be encouraged by progress toward our most important priority, which is to attain regulatory authorization of GraftAssureDx. In late July, the FDA completed the current phase of its substantive review of GraftAssureDx in a timely manner. The agency requested additional information from us, which is typical in a regulatory authorization process such as this. We view ourselves as being in the later stages of the review process, and after a thorough dialogue with the ag…
Open exhibit ↗Current Report · Items 2.02, 7.01, 8.01, 9.01 · 8-K
Insight Molecular Diagnostics Inc.
IMDXNASDAQEQUITYCurrent
Results of Operations and Financial Condition · Regulation FD Disclosure · Other Events
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.…
Disclosure sections
Item 2.02Item 2.02 - Results of Operations
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 7.01Item 7.01 - Regulation FD Disclosure
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 8.01Item 8.01 - Other Events
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.