Every 8-K that Insight Molecular Diagnostics Inc. (IMDX) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow IMDX and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full IMDX filings page.
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.
Insight Molecular Diagnostics Inc. reported results of its 2026 annual shareholder meeting, where shareholders approved an amendment to the 2018 Equity Incentive Plan adding 1,750,000 shares, bringing total shares authorized for equity awards to 5,550,000.
All four director nominees were elected, the appointment of CBIZ CPAs P.C. as independent registered public accounting firm for the year ending December 31, 2026 was ratified, and shareholders approved, on a non-binding advisory basis, named executive officer compensation. The meeting had a quorum with 23,954,212 shares represented, equal to 74.19% of the company’s voting power as of the record date.
Insight Molecular Diagnostics reported Q1 2026 results and highlighted progress toward commercializing its GraftAssure kidney transplant rejection tests. Net revenue was just $32,000, down sharply from $2.1 million a year earlier, as the lab focused on research supporting its FDA submission instead of revenue-producing work.
The company generated gross profit of $15,000 and recorded a GAAP net loss of $4.3 million, or $0.12 per share. On a non-GAAP basis, adjusted net loss was $9.6 million and adjusted EBITDA loss was $9.1 million, reflecting higher investment in R&D, sales and marketing ahead of launch.
Cash, cash equivalents and restricted cash totaled $29.4 million at quarter-end, strengthened by a $26.0 million registered direct offering that delivered about $24.6 million in net proceeds. Management described encouraging FDA dialogue on GraftAssureDx, early research-use kit orders in Europe and Asia, and growing engagement in the GALACTIC registry study as it targets a large transplant monitoring market.
Insight Molecular Diagnostics Inc. filed a current report to correct an exhibit previously attached to its Annual Report on Form 10-K for the year ended December 31, 2025. The earlier filing inadvertently included shareholder voting provisions that are not part of the Company’s Third Amended and Restated Bylaws.
The Company is now providing the correct copy of its Third Amended and Restated Bylaws as Exhibit 3.1 to this report. The correction is described as a clerical error and does not change any other disclosures contained in the Form 10-K.
Insight Molecular Diagnostics Inc. reported fourth quarter and full-year 2025 results and highlighted major milestones for its GraftAssure transplant diagnostics platform. Full-year net revenue was $4.1 million with gross profit of $2.3 million at a 56.7% gross margin, while the company recorded a net loss of $50.2 million.
Operating expenses were $53.4 million in 2025, including a $14.6 million non-cash impairment of oncology intangible assets, and non-GAAP operating expenses rose 37% year over year. Cash, cash equivalents and restricted cash totaled $12.9 million at year-end, and in February 2026 the company completed a $26.0 million registered direct offering with net proceeds of about $24.6 million.
The company submitted its GraftAssureDx kidney transplant rejection test for FDA de novo review, expects a 150-day review timeline under FDA guidance, and is targeting U.K. CE marking in Q2 2026. It is engaging 37 U.S. and 11 international transplant centers, has secured favorable head-to-head study data versus centralized competitors, and is investing in sales and marketing as it transitions toward commercialization.
Insight Molecular Diagnostics Inc. entered into a material Specimen Collection Agreement with Quest Diagnostics Incorporated on February 20, 2026. Quest Diagnostics will provide specimen collection-related services for samples on which Insight will perform its GraftAssureCore™ blood test, which measures donor-derived cell free DNA using a PCR-based platform.
The parties also agreed that, for a specified period, they will use commercially reasonable efforts to negotiate in good faith additional rights related to the GraftAssure technology. Fees will be paid to Quest Diagnostics for the services under this agreement.
Insight Molecular Diagnostics Inc. entered into securities purchase agreements with institutional investors for a registered direct offering of 3,482,498 common shares and pre-funded warrants to purchase up to 1,043,478 shares at $5.75 per share (or $5.7499 per pre-funded warrant).
The transaction is expected to generate aggregate gross proceeds of approximately $26.0 million and net proceeds of about $24.5 million after placement fees and expenses. The company plans to use the funds for general corporate purposes, focusing on transplantation R&D and expanding its GraftAssure product line, including heart transplant rejection testing.
The pre-funded warrants carry a $0.0001 exercise price and are exercisable until fully exercised, subject to a beneficial ownership cap of 4.99% or, at the holder’s election, 9.99% of outstanding common stock, adjustable with at least 61 days’ prior notice.
Insight Molecular Diagnostics Inc. filed a current report to notify investors that it may use a new slide presentation in meetings with investors or analysts. The presentation is attached as Exhibit 99.1 and may be used from time to time to discuss the company and its business.
The company states that this material is being furnished under a disclosure item for Regulation FD and is not considered filed for purposes of liability under the Exchange Act. The presentation will only be incorporated into other SEC filings if explicitly referenced there.
Insight Molecular Diagnostics Inc. (IMDX) furnished an 8‑K to announce that it issued a press release with financial results for the three and nine months ended September 30, 2025. The press release is attached as Exhibit 99.1 and incorporated by reference. The Company noted that the information provided under Item 2.02, including Exhibit 99.1, is being furnished and not filed under the Exchange Act, and therefore is not subject to Section 18 liabilities, nor automatically incorporated into other filings except as specifically referenced. IMDX’s common stock trades on The Nasdaq Stock Market LLC under the symbol IMDX.
Insight Molecular Diagnostics Inc. reported new equity awards and a contract change for key executives. On September 28, 2025, the board granted stock options under the Amended and Restated 2018 Equity Incentive Plan to several leaders. Josh Riggs, President and CEO, received options to purchase 400,000 shares of common stock. Andrea James, CFO, and Dr. Ekkehard Schütz, Chief Science Officer, each received options for 235,000 shares, and James Liu, Vice President Accounting, Controller, Treasurer and Principal Accounting Officer, received options for 18,000 shares.
All options have an exercise price of $3.33 per share and vest over three years, with one-third vesting on the first anniversary and the remainder vesting in equal monthly installments over the following two years, subject to continued service. On September 29, 2025, the company also amended Dr. Schütz’s employment agreement so that his term continues until it is terminated in accordance with that agreement, rather than ending on a fixed four-year term.
Insight Molecular Diagnostics Inc. reported that its Board of Directors and Compensation Committee approved increases to the annual base salaries of two senior executives. Effective September 15, 2025, the annual base salary of President and Chief Executive Officer Joshua Riggs rose from $420,000 to $520,000, and the annual base salary of Chief Financial Officer Andrea James increased from $341,250 to $441,250. These changes reflect updated compensation levels for the company’s top leadership.