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  4. [8-K] Insight Molecular Diagnostics Inc. Reports Material Event

Insight Molecular Diagnostics (IMDX) reports Q2 results and details FDA AIR on GraftAssureDx

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Insight Molecular Diagnostics Inc. reported that it issued a press release on August 10, 2026 announcing financial results for the three and six months ended June 30, 2026; the release is furnished as Exhibit 99.1 and is not treated as filed under securities laws. The company also disclosed receiving an Additional Information Request (AIR) from the FDA regarding its submission for the GraftAssureDx test and must provide a complete response within 180 days. The company characterizes the AIR as a routine part of the FDA submission process, states it is prepared to respond, and anticipates one more FDA meeting before the fourth quarter of 2026. Forward‑looking statements cautions are included.

Positive

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Negative

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Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 7.01 Regulation FD Disclosure Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 8.01 Other Events Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
AIR response deadline 180 days Time allowed to respond to FDA Additional Information Request for GraftAssureDx
Quarter end date June 30, 2026 End of the three and six month periods covered by reported results
Press release date August 10, 2026 Date of press release announcing financial results and FDA AIR disclosure
Additional Information Request regulatory
"received an Additional Information Request (“AIR”) from the FDA regarding its submission"
Regulation FD Disclosure regulatory
"Item 7.01 Regulation FD Disclosure. On August 10, 2026, the Company announced"
Regulation FD disclosure requires public companies to share important, market-moving information with everyone at the same time instead of tipping off analysts or large investors first. Think of it as making sure all players on a field hear the same announcement simultaneously; that fairness helps investors trust that stock prices reflect the same information and reduces the risk of sudden, unfair trading advantages or regulatory penalties for selective leaks.
forward-looking statements regulatory
"Certain statements in this on may be considered “forward-looking statements”"
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.
Private Securities Litigation Reform Act of 1995 regulatory
"within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995"

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FAQ

What financial period did Insight Molecular Diagnostics (IMDX) report on August 10, 2026?
Insight Molecular Diagnostics reported results for the three and six months ended June 30, 2026. The company issued a press release with these results, which is furnished as Exhibit 99.1 and not deemed filed under securities laws.

What FDA communication did IMDX receive regarding GraftAssureDx?
IMDX received an Additional Information Request (AIR) from the FDA related to its GraftAssureDx submission. The company states this AIR is viewed as a routine part of the process and that it is prepared to provide the requested information.

How long does Insight Molecular Diagnostics have to respond to the FDA AIR?
Insight Molecular Diagnostics must provide a complete response to the FDA’s Additional Information Request within 180 days. This deadline governs the company’s next steps in the GraftAssureDx submission process and frames the near‑term regulatory timeline.

Does IMDX expect further FDA meetings about GraftAssureDx?
Yes. The company expects to have one more FDA meeting before the fourth quarter of 2026 regarding GraftAssureDx. This anticipated meeting follows its planned response to the Additional Information Request and continues the review process.

Is the IMDX earnings press release incorporated into other SEC filings?
The earnings press release furnished as Exhibit 99.1 is explicitly stated as not being deemed filed or incorporated by reference into other Securities Act or Exchange Act filings, except where specifically referenced by the company.

How does IMDX describe its forward-looking statements in this 8-K?
IMDX states that certain statements are forward-looking under the Private Securities Litigation Reform Act of 1995, notes they are based on inherently uncertain assumptions, and cautions readers not to place undue reliance on them, absent required legal updates.
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

Current Report

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): August 10, 2026

 

Insight Molecular Diagnostics Inc.

(Exact name of Registrant as specified in its charter)

 

California   1-37648   27-1041563
(State or other jurisdiction
of incorporation)		   (Commission
File No.)		   (IRS Employer
Identification No.)

 

2 International Plaza Dr., Suite 510

Nashville, Tennessee 37217

(Address of principal executive offices) (Zip code)

 

(615) 255-8880

Registrant’s telephone number, including area code

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities Registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Common stock, no par value   IMDX   The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ☐

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

 
 

 

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

 

 

Source: View Original Filing on SEC EDGAR

Filing Exhibits & Attachments

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Press Releases

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