Form 8-K

8-K — Insight Molecular Diagnostics Inc.

Accession: 0001493152-26-036863

Filed: 2026-08-10

Period: 2026-08-10

CIK: 0001642380

SIC: 2835 (IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES)

Item: Results of Operations and Financial Condition

Item: Regulation FD Disclosure

Item: Other Events

Item: Financial Statements and Exhibits

Documents

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2026-08-10

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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.)

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 ☐

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.

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.

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

EX-99.1

Filename: ex99-1.htm · Sequence: 2

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,

continue to be encouraged by progress toward our most important priority, which is to attain regulatory authorization of GraftAssureDx.

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 agency, we are encouraged to be working with a clear, well-defined set

of remaining items. This welcome milestone comes after three years of rigorous kitted product development.

also have been pleased regarding the agency’s swift engagement and its ability to deliver timely feedback throughout. We have had

productive dialogue with the agency since submitting GraftAssureDx for regulatory review in late March, and we expect that to continue.

We would characterize our dialogue with the FDA as routine and within the realm of our expectations.

Our

submission was, to our knowledge, the first-ever kitted dd-cfDNA assay to be submitted for FDA authorization.

a reminder, we are not building this product alone. Our GraftAssure assay runs on a digital PCR instrument made by Bio-Rad Laboratories

(NYSE:BIO), which has invested in our company. Bio-Rad commented:

“Our

collaboration with iMDx on GraftAssureDx reflects the kind of innovative thinking we look for in a partner. Droplet DigitalTM

PCR is well suited to the demands of transplant monitoring, where precise and reproducible measurement matters, and GraftAssureDx brings

that capability into the clinical laboratory setting. We are proud to partner with iMDx on this program and remain confident in the path

forward and positive impact to patient lives.” –Jonathan Seaton, SVP Corporate Business Development, Bio-Rad Laboratories

also have expanded dialogue with several additional players in the diagnostics industry. We now believe that most major U.S. reference

labs are interested in adopting in-house dd-cfDNA testing, with their interest bolstered by reimbursement clarity from Medicare and the

release of favorable head-to-head data regarding our assay, both of which are described in more detail below,

High-volume

labs that are performing other routine transplant tests are considering the addition of a reimbursed dd-cfDNA test. We believe they may

see our test as a natural product line extension for their other transplant test offerings, and as a great way to serve their existing

transplant center and nephrology clinic customers nationwide. We believe that these labs value the ability to deliver all the testing

needed for a patient in one patient visit for blood draws, and even potentially via one report for clinicians.

Contextual

overview for investors:

iMDx

aims to deliver proven, more affordable, faster tests that can be run in-house at local transplant center laboratories. We have designed

the GraftAssureDx molecular test to be sold as a test kit so that transplant center laboratories can run tests locally. By running tests

locally, laboratories can deliver critical test results to the physicians of transplant patients much more quickly than can be done with

the currently available send-out tests. Our company is now seeking FDA marketing authorization to sell these kits in the U.S. If GraftAssure

technology becomes available commercially as a test kit, it may be an industry-transforming event for transplanted organ rejection monitoring.

Over

time, iMDx sees three potential paradigm shifts in transplanted organ health monitoring:

● Bringing

testing closer to the patient: The first is a shift in the location of where donor-derived

cell-free DNA (dd-cfDNA) testing is performed – migrating out of a send-out service

model and into hospital-based laboratories that can deliver results locally. iMDx seeks to

demonstrate that in-house testing is better for patients and physicians. (As a reminder,

dd-cfDNA is an established biomarker for assessing the health of a transplanted organ through

a simple blood draw.)

● Expanding

the clinical role of dd-cfDNA: The second shift is the growing potential for dd-cfDNA

testing, powered by digital PCR technology, to support earlier detection of allograft injury,

longitudinal monitoring of transplant health, and assessment of response to emerging anti-rejection

therapies.

● Advancing

from rule-out testing to comprehensive decision support: The third shift is the expansion

of dd-cfDNA testing from mainly being used to rule out patients’ need for confirmatory

biopsy testing, to also being used proactively to predict whether a patient may be progressing

toward organ rejection. This important shift is enabled by GraftAssure’s ability to

measure both dd-cfDNA percentage and absolute, true concentrations as copies per milliliter

of plasma.

Other

highlights since our May 2026 update:

Reimbursement

and market access

● A

favorable Medicare local coverage decision (LCD) was issued by MolDX that expands the

reimbursement framework for dd-cfDNA testing by covering surveillance testing at an increased

frequency compared to a draft policy released last year. This includes doubling testing rates

in the second and third years post-kidney transplant to four tests per year and allowing

for a frequency per year thereafter according to peer-reviewed literature and societal guidelines.

The new Medicare policy also cites iMDx-affiliated research. (July 16 release)

● Medicare

(MolDX) confirmed iMDx’s reimbursement coverage for treatment-response monitoring.

We believe clinicians intend to increasingly use dd-cfDNA testing to guide ongoing anti-rejection

drug therapy. MolDX has confirmed that testing under this rationale is reimbursed. (July

23 release)

Clinical

evidence and peer-reviewed publications

● A

new multicenter study conducted across eight transplant centers in Germany and Austria, published

in Kidney International, adds to the growing evidence that donor-derived cell-free

DNA (dd-cfDNA) can do more than rule out biopsy. The retrospective study evaluated 70

kidney transplant recipients treated with Johnson & Johnson’s daratumumab

(DARZALEX®) for microvascular inflammation (MVI) and antibody-mediated rejection

(AMR), using our GraftAssure test to monitor therapeutic efficacy. Daratumumab treatment

was associated with stabilization of kidney function, with dd-cfDNA and albuminuria levels

declining early in treatment. We believe this reinforces dd-cfDNA’s expanding role

in actively guiding and monitoring rejection treatment.

● The

American Journal of Transplantation published data on iMDx’s new GraftAssure Combination

Model (CM)-Score. Results demonstrated that our test roughly doubled positive predictive

value (81% vs. a 54% published benchmark) versus single-metric dd-cfDNA measurement in

kidney transplant patients, while retaining a high negative predictive value (91%). The company

has launched its GALACTIC registry to build on these findings. (June 11 release)

● Clinical

Chemistry (the journal of the Association for Diagnostics & Laboratory Medicine) published

the first head-to-head comparison of GraftAssure’s digital PCR-based technology

against a leading NGS-based competitor assay, showing 99.2% agreement across a wide range

of dd-cfDNA results under real-world clinical conditions. GraftAssure demonstrated superior

analytical sensitivity and a lower limit of quantification. (June 16 release)

● The

Lancet Regional Health – Europe published an extension of the 2024 New England Journal

of Medicine felzartamab study, showing GraftAssure-guided dd-cfDNA monitoring enabled roughly

two-thirds drug-sparing versus fixed dosing while maintaining treatment efficacy and safety

— pointing to a market-expansion use case for GraftAssure beyond rejection detection

and biopsy rule-out testing. (July 23 release)

● Chief

Science Officer Prof. Dr. Ekkehard Schuetz, co-inventor of the underlying dd-cfDNA technology,

published his 200th scientific paper. He is ranked in the top 2.5% of researchers

worldwide by H-index (58) and top 2% within laboratory diagnostics. (June 29 release)

Commercial

and scientific community engagement

● iMDx

showcased its GraftAssure technology, hosted a key opinion leader reception, and presented

third-party head-to-head data at the American Transplant Congress in Boston, from

June 20–24. (June 9 release)

● iMDx

partnered with the American Society of Transplant Surgeons (ASTS) to name the recipients

of a $100,000, company-funded health-economics research grant (Drs. Kenneth Andreoni of Thomas

Jefferson University and Kenneth Chavin of Temple Health) to study the economics of in-house

versus send-out dd-cfDNA testing. This research is intended to support GraftAssureDx commercialization

planning. (June 22 release)

Upcoming

KOL call on August 17th to highlight heart transplant testing:

we continue to plan for commercializing a kitted version of GraftAssure for kidney transplant testing, the next organ of focus for GraftAssure’s

application is heart transplant testing. To that end, we will be hosting a virtual key opinion leader (KOL) event to discuss in-house

heart transplanted organ rejection testing on Monday, August 17, 2026, at 10:00 a.m. ET. The event will feature Dr. Max Jacob Liebo,

M.D., Associate Professor and Program Director, Advanced Heart Failure and Transplant Cardiology Fellowship at Loyola University Medical

Center.

The

call will also feature brief remarks from CEO Josh Riggs and iMDx Vice President of Medical Affairs Dr. Nick Ioannou, whose extensive

experience includes previously serving as a medical science liaison for organ health and genetics at Natera.

will be issuing a separate press release with further information.

Thank

you for your interest in iMDx and we look forward to updating you as we transition into commercialization.

Sincerely,

iMDx Management

Second

Quarter 2026 financial overview

● In

Q2 2026, our revenues were approximately $239,000.

○ Most

of our revenues were derived from laboratory services performed at our clinical laboratory

in Tennessee. Our strategic goal is to sell diagnostic test kits for clinical use, and as

we await potential FDA authorization, we remain essentially “pre-revenue.” Our

laboratory services are performed at the request of select clients, and we see our laboratory

services revenue as a testament to our team’s ability to achieve the on-time delivery

of clear, scientifically sound, and accurate data sets to our clients.

○ We

sold $21,000 in research-use-only kits in the quarter. As previously communicated, we do

not expect material revenue on our kitted product sales until after we have achieved regulatory

authorization to market GraftAssureDx.

● We

reported gross profit of $157,000 in Q2 2026, representing a 65.7% gross margin.

● In

Q2 2026, operating expenses of $11.6 million included a non-cash loss of $2.3 million from

a change in the fair value of our contingent consideration, as well as $661,000 in non-cash

stock-based compensation expenses, and $641,000 in non-cash depreciation and amortization

expenses. The contingent consideration relates to acquisition accounting and certain earn-out

arrangements related to our prior acquisitions, under which payments become due only as we

achieve certain milestones or generate revenue. It is remeasured each period based on assumptions

including the expected timing and amount of future revenue, probability of achieving certain

earnout milestones, and discount rates.

○ Excluding

the impact of these non-cash net adjustments in Q2 2026, our non-GAAP operating expenses

decreased 13% sequentially over the first quarter of 2026, and increased 26% year over year.

The sequential decline in Q2 2026 operating expenses reflected the winding down of costs

associated with our GraftAssureDx submission. The increased investments year-over-year largely

reflect our preparations for commercial launch.

○ In

Q2 2026, research and development expenses decreased 9% sequentially, or by about $467,000,

to $4.5 million. This decrease reflected lower laboratory and supplies costs as we concluded

most of our FDA submission work streams.

● As

noted last quarter, Q1 2026 had higher-than-average research and development expenses as

we approached FDA submission, including expenses related to FDA-compliant software development,

laboratory supplies, kit production, and personnel costs associated with our clinical trial,

including regulatory consulting fees. As expected, Q2 2026 R&D expenses declined sequentially.

We expect R&D expenses to stabilize near recent levels as we shift resources from FDA

submission work toward ongoing clinical evidence generation, including our GALACTIC registry.

○ In

Q2 2026, sales and marketing expenses decreased $486,000 sequentially to $1.9 million. We

continue to invest in go-to-market activities as we prepare for commercial launch of GraftAssureDx

for kidney, including marketing, advertising, travel, consulting fees and personnel.

○ General

and administrative expenses fell slightly sequentially to $2.9 million in Q2 2026.

● Our

Q2 2026 net loss was $11.3 million, or $0.31 net loss per share.

○ Non-GAAP

Net Loss: Our Q2 2026 adjusted net loss of $8.3 million represented a loss of $0.23 per share.

Our adjusted net loss excludes the non-cash charges of stock-based compensation expenses

and the change in fair value of our contingent consideration (“Non-GAAP Net Loss”).

Please refer to the table below, “Reconciliation of Non-GAAP Financial Measures,”

for additional disclosures and information.

○ Non-GAAP

Adjusted EBITDA Loss: Our Q2 2026 adjusted earnings or loss before interest, income taxes,

depreciation, amortization, stock-based compensation, change in fair value of contingent

consideration, and other non-operating items (“Adjusted EBITDA Loss”) was $7.8

million. The sequential decrease in Adjusted EBITDA Loss represented cost discipline and

higher gross profit in the quarter.

○ Please

refer to the table below, “Reconciliation of Non-GAAP Financial Measures,” for

additional disclosures and information.

● Our

Q2 2026 per share results reflect 36.8 million weighted average shares outstanding and include

the effects of 4.1 million unexercised pre-funded warrant shares that were issued in April

2024, February 2025, and February 2026 to a certain investor.

○ Inclusive

of all outstanding shares, pre-funded warrants, and subsequent issues for stock awards, our

pro-forma fully diluted share count would be 36.9 million shares as of this earnings release

date.

● Our

cash, cash equivalents, and restricted cash balance at the end of the second quarter was

$18.7 million.

● Our

Q2 2026 outgoing cash flow from operations (net cash used in operating activities) of $9.3

million, combined with capital expenditures of about $779,000, resulted in outgoing free

cash flow of approximately $10 million. While core operating expenses declined in the second

quarter, outgoing cash flow widened due to working capital timing, including our annual bonus

payment and vendor payments. We expect outgoing free cash flow to narrow in the back half

of the year.

● As

noted in our May update, in 2026, we expect to continue to be thoughtful about capital allocation,

hiring, and expense growth.

Webcast

and Conference Call Information

Live

Zoom Call and Webcast on August 10, 2026, at 2:00 PMPT / 5:00 PM ET.

Those

interested may access the live Zoom call by registering here: iMDx Q2 2026 Earnings Webinar

replay of the Zoom call will be available on the Company’s website shortly after the call.

iMDx

Transplant Products and Product Candidates in Development

iMDx’s

flagship transplant testing technology quantifies a molecular biomarker known as donor-derived cell-free DNA (dd-cfDNA). The Company’s

scientists in Germany and the U.S. have played a critical role over the past decade in developing the science that helped establish dd-cfDNA

as a trusted biomarker of transplant rejection. iMDx is commercializing this technology using a market-disruptive business strategy.

Under the GraftAssure™ brand, iMDx’s transplant diagnostics include the following:

● GraftAssureCore

– The company’s laboratory-developed test (LDT), currently reimbursed by CMS

and performed at iMDx’s CLIA-certified laboratory in Franklin, Tennessee.

● GraftAssureIQ

– A research-use-only (RUO) kit intended and labeled for non-clinical applications.

● GraftAssureDx

– The in vitro diagnostic (IVD) kit currently under FDA review for use in clinical

decision-making.

About

Insight Molecular Diagnostics, Inc.

Insight

Molecular Diagnostics is a pioneering diagnostics technology company whose mission is to democratize access to novel molecular diagnostic

testing to improve patient outcomes. Investors may visit https://investors.imdxinc.com/ for more information.

GraftAssureCore™,

GraftAssureIQ™, GraftAssureDx™, GraftAssure™, DetermaIO™, and DetermaCNI™ are trademarks of Insight Molecular

Diagnostics Inc.

Forward-Looking

Statements

Any

statements that are not historical fact (including, but not limited to, statements that contain words such as “will,” “believes,”

“plans,” “anticipates,” “expects,” “estimates,” “may,” and similar expressions)

are forward-looking statements. These statements include those pertaining to, among other things, the company’s efforts to commercialize

its GraftAssure technology, discussions with the FDA and expected FDA marketing authorization to sell GraftAssureDx, the belief that

most major U.S. reference labs are interested in adopting in-house dd-cfDNA testing, interest from industry participants and investors,

the company’s plans to deliver proven, more affordable and faster tests that can be run in-house at local transplant center laboratories,

anticipated paradigm shifts in transplanted organ health monitoring, the belief that clinicians tend to increasingly use dd-cfDNA testing

to guide ongoing anti-rejection drug therapy, potential use cases for GraftAssure beyond rejection detection and biopsy rule-out testing,

the company’s upcoming KOL call to highlight heart transplant testing, transplant and other product candidates in development,

and other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management.

Forward-looking

statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization

of diagnostic tests or products, uncertainty in the results of clinical trials or regulatory approvals, the capacity of Insight Molecular

Diagnostics’ third-party supplied blood sample analytic system to provide consistent and precise analytic results on a commercial

scale, potential interruptions to supply chains, the need and ability to obtain future capital, maintenance of intellectual property

rights in all applicable jurisdictions, obligations to third parties with respect to licensed or acquired technology and products, the

need to obtain third party reimbursement for patients’ use of any diagnostic tests Insight Molecular Diagnostics or its subsidiaries

commercialize in applicable jurisdictions, and risks inherent in strategic transactions such as the potential failure to realize anticipated

benefits, legal, regulatory or political changes in the applicable jurisdictions, accounting and quality controls, potential greater

than estimated allocations of resources to develop and commercialize technologies, or potential failure to maintain any laboratory accreditation

or certification. Actual results may differ materially from the results anticipated in these forward-looking statements and accordingly

such statements should be evaluated together with the many uncertainties that affect the business of Insight Molecular Diagnostics, particularly

those mentioned in the “Risk Factors” and other cautionary statements found in Insight Molecular Diagnostics’ Securities

and Exchange Commission (SEC) filings, which are available from the SEC’s website. You are cautioned not to place undue reliance

on forward-looking statements, which speak only as of the date on which they were made. Insight Molecular Diagnostics undertakes no obligation

to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as

required by law.

FDA

CAUTION:

This press release concerns certain products that are under clinical investigation, and which have not yet been cleared or authorized

for marketing by the U.S. Food and Drug Administration. These products are currently limited by federal law to investigational use, and

no representation is made as to the safety or effectiveness of these products for the purposes for which they are being investigated.

Investor

Contact:

Douglas Farrell

LifeSci Advisors LLC

imdx@lifesciadvisors.com

Financial Tables Follow

INSIGHT

MOLECULAR DIAGNOSTICS INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands)

June 30,

2026

December 31,

2025

(Unaudited)

ASSETS

CURRENT ASSETS

Cash and cash equivalents

$ 17,756

$ 11,583

Accounts receivable, net of allowance for credit losses of $2 and $11, respectively

192

1,128

Inventories

207

446

Restricted cash, current

729

Prepaid expenses and other current assets

1,659

1,420

Total current assets

20,543

15,306

NONCURRENT ASSETS

Right-of-use operating and financing lease assets, net

2,097

2,815

Machinery and equipment, net, and construction in progress

6,004

6,435

Restricted cash, noncurrent

243

607

Other noncurrent assets

556

593

TOTAL ASSETS

$ 29,443

$ 25,756

LIABILITIES AND SHAREHOLDERS’ DEFICIT

CURRENT LIABILITIES

Accounts payable

$ 1,871

$ 2,544

Due to related party

1,979

2,780

Accrued compensation

1,904

2,461

Accrued royalties

1,116

Accrued expenses and other current liabilities

1,000

939

Operating and financing lease liabilities, current

1,710

1,807

Contingent consideration liabilities, current

706

428

Total current liabilities

10,286

12,075

NONCURRENT LIABILITIES

Operating and financing lease liabilities, noncurrent

915

1,690

Contingent consideration liabilities, noncurrent

39,541

43,455

TOTAL LIABILITIES

50,742

57,220

Commitments and contingencies

SHAREHOLDERS’ DEFICIT

Preferred stock, no par value, 5,000 shares authorized; no shares issued and outstanding

—

Common stock, no par value, 230,000 shares authorized; 32,623 and 28,683 shares issued and outstanding at June 30, 2026 and December 31, 2025, respectively

394,945

369,211

Accumulated other comprehensive income

Accumulated deficit

(416,311 )

(400,761 )

Total shareholders’ deficit

(21,299 )

(31,464 )

TOTAL LIABILITIES AND SHAREHOLDERS’ DEFICIT

$ 29,443

$ 25,756

INSIGHT

MOLECULAR DIAGNOSTICS INC.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS

OF OPERATIONS

(In thousands, except per share data)

Three Months Ended

June 30,

Six Months Ended

June 30,

2026

2025

2026

2025

Net revenue

$ 239

$ 518

$ 271

$ 2,656

Cost of revenues

180

993

Gross profit

157

338

172

1,663

Operating expenses:

Research and development

4,486

3,269

9,439

6,193

Sales and marketing

1,916

1,460

4,318

2,666

General and administrative

2,873

2,647

5,864

5,762

Change in fair value of contingent consideration

2,284

2,804

(3,634 )

3,683

Total operating expenses

11,559

10,180

15,987

18,304

Loss from operations

(11,402 )

(9,842 )

(15,815 )

(16,641 )

Other (expenses) income:

Interest expense

(20 )

(25 )

(43 )

(54 )

Other income, net

162

125

308

282

Total other income, net

142

100

265

228

Loss before income taxes

(11,260 )

(9,742 )

(15,550 )

(16,413 )

Income taxes

—

Net loss

$ (11,260 )

$ (9,742 )

$ (15,550 )

$ (16,413 )

Net loss per share:

Net loss per share - basic and diluted

$ (0.31 )

$ (0.30 )

$ (0.44 )

$ (0.57 )

Weighted average shares outstanding - basic and diluted

36,750

32,023

35,640

28,876

INSIGHT

MOLECULAR DIAGNOSTICS INC.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS

OF CASH FLOWS

(In thousands)

Three Months Ended

June 30,

Six Months Ended

June 30,

2026

2025

2026

2025

CASH FLOWS FROM OPERATING ACTIVITIES:

Net loss

$ (11,260 )

$ (9,742 )

$ (15,550 )

$ (16,413 )

Adjustments to reconcile net loss to net cash used in operating activities:

Depreciation and amortization expense

665

559

1,296

1,043

Amortization of intangible assets

—

Stock-based compensation

661

504

1,276

977

Equity compensation for bonus awards and consulting services

Change in fair value of contingent consideration

2,284

2,804

(3,634 )

3,683

Unrealized foreign currency losses

149

188

Changes in operating assets and liabilities:

Accounts receivable

(35 )

3,028

936

1,101

Inventories

175

(234 )

239

(283 )

Prepaid expenses and other assets

(589 )

(168 )

(140 )

(253 )

Accounts payable and accrued liabilities

(1,105 )

(3,113 )

(1,210 )

(2,086 )

Operating lease assets and liabilities

(84 )

(35 )

(167 )

(65 )

Net cash used in operating activities

(9,268 )

(6,174 )

(16,907 )

(12,013 )

CASH FLOWS FROM INVESTING ACTIVITIES:

Machinery and equipment purchases, and construction in progress

(779 )

(349 )

(1,392 )

(656 )

Net cash used in investing activities

(779 )

(349 )

(1,392 )

(656 )

CASH FLOWS FROM FINANCING ACTIVITIES:

Proceeds from sale of common shares

—

26,024

29,143

Financing costs to issue common shares

(185 )

—

(1,368 )

(487 )

Proceeds from exercise of stock options

—

Taxes paid related to net share settlement of stock-based awards

(237 )

—

(237 )

—

Repayment of financing lease obligations

(152 )

(114 )

(295 )

(212 )

Net cash provided by financing activities

(564 )

(114 )

24,134

28,444

Effect of exchange rate changes on cash and cash equivalents

(16 )

(105 )

(26 )

(124 )

NET CHANGE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH

(10,627 )

(6,742 )

5,809

15,651

CASH, CASH EQUIVALENTS AND RESTRICTED CASH, BEGINNING

29,355

32,729

12,919

10,336

CASH, CASH EQUIVALENTS AND RESTRICTED CASH, ENDING

$ 18,728

$ 25,987

$ 18,728

$ 25,987

INSIGHT

MOLECULAR DIAGNOSTICS INC.

RECONCILIATION OF NON-GAAP FINANCIAL

MEASURES

NON-GAAP NET LOSS AND ADJUSTED EBITDA

LOSS

addition to financial results determined in accordance with U.S. generally accepted accounting principles (“GAAP”), this

press release also includes non-GAAP financial measures (as defined under SEC Regulation G). We believe that disclosing the adjusted

amounts is helpful in assessing our ongoing performance, providing insight into the Company’s core operating performance by excluding

certain non-cash and other non-operating items that may obscure the underlying trends in the business. These non-GAAP financial measures,

when viewed in a reconciliation to respective GAAP financial measures, provide an additional way of viewing the Company’s results

of operations and factors and trends affecting the Company’s business. These non-GAAP financial measures should be considered as

a supplement to, and not as a substitute for, or superior to, the respective financial results presented in accordance with GAAP.

The

following is a reconciliation of the non-GAAP financial measures to the most directly comparable GAAP measure:

Three Months Ended

June 30,

March 31,

June 30,

2026

2025 (1)

(unaudited)

(In thousands)

Net loss (GAAP)

$ (11,260 )

$ (4,290 )

$ (9,742 )

Stock-based compensation

661

615

504

Change in fair value of contingent consideration

2,284

(5,918 )

2,804

Non-GAAP net loss

(8,315 )

(9,593 )

(6,434 )

Depreciation and amortization expenses

665

631

559

Interest expense

Other income, net

(162 )

(146 )

(125 )

Income taxes

—

Adjusted EBITDA loss, a non-GAAP financial measure

$ (7,792 )

$ (9,085 )

$ (5,975 )

Net loss per share (GAAP)

$ (0.31 )

$ (0.12 )

$ (0.30 )

Non-GAAP net loss per share

$ (0.23 )

$ (0.28 )

$ (0.20 )

Weighted average shares outstanding

36,750

34,519

32,023

(1) The

June 2025 reconciliation line-items have been presented to conform to the current presentation.

The newly titled total “Adjusted EBITDA loss, a non-GAAP financial measure” reported

for June 2025 is unchanged from the June 2025 “Consolidated non-GAAP loss from operations,

as adjusted” as previously reported.

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