8-K

Insight Molecular Diagnostics Inc. (IMDX)

8-K 2025-08-11 For: 2025-08-11
View Original
Added on April 08, 2026

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 11, 2025

InsightMolecular Diagnostics Inc. ****

(Exact name of Registrant as specified in its charter)

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

2International 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<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement<br> 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<br> of each class Trading<br> Symbol(s) Name<br> of each exchange on which registered
Common<br> stock, no par value IMDX The<br> 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. ☐

Item2.02 Results of Operations and Financial Condition.


On August 11, 2025, Insight Molecular Diagnostics Inc. (“we,” “us,” “our,” the “Company” or “iMDx”) issued a press release announcing our financial results for the six months ended June 30, 2025. 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.


Item9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number Description
99.1 Press release dated August 11, 2025.
104 Cover<br> 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:<br> August 11, 2025 By: /s/ Peter Hong
Name: Peter<br> Hong
Title: Vice<br> President, General Counsel

Exhibit99.1

IMDXReports Q2 2025 Results and Momentum Toward GraftAssureDx Launch


Reiterating<br> timelines for FDA submission in 2025
Transplant<br> clinical trial has attracted leading transplant hospitals
Booked<br> first revenue from first-generation GraftAssureIQ research-use-only kits; began shipping<br> second generation kits in June

NASHVILLE, TENN., August 11, 2025 — Insight Molecular Diagnostics Inc., or iMDx, (Nasdaq: IMDX), today published the following letter to shareholders in conjunction with its second quarter results:

Fellow shareholders,

We are closer than we have ever been to delivering a regulated kitted transplant monitoring assay to the market – and we are pleased to report a series of recent and timely accomplishments that we believe amount to material progress. These recent developments, which we highlight below, as well as ongoing strategic discussions, have strengthened our confidence regarding our ability to capture share in the $1   billion total addressable transplant rejection testing market.

To<br> recap what we mean by a regulated kitted assay: We are designing a complex molecular lab test so that it can fit into a box,<br> or a kit, to enable localized diagnostic testing.   In January 2023, when we first decided to commercialize our transplant<br> rejection-related intellectual property (IP) by designing a kitted test, we essentially planted a flag that said that<br> we would put our assay through the regulatory approval processes of the FDA and its EU equivalent. This decision was significant<br> because in the U.S., we estimate that most complex molecular diagnostics tests have been run without FDA authorization,<br> which has limited their market penetration.

Moreover, these non-FDA-authorized North American lab tests, which are performed at centralized locations  , are not easily accessible to hospitals in the rest of the world. Therefore, obtaining regulatory authorization is a key step toward achieving our mission to democratize access to these important tests. With FDA and EU-equivalent authorization, we anticipate selling test kits to hospital labs, thereby empowering hospitals to run the tests themselves to expediently deliver actionable results.

Itis our belief that if we do the hard work of designing a lab test in a kitted form and achieve regulatory authorization, thenwe will not only democratize access to these tests – thereby bringing care closer to the patient and helping hospitals to operatemore sustainably – but also create a rapidly growing, high-margin, recurring revenue business model.


We continue to carefully manage our FDA data submission project and remain on track to submit our kitted test, GraftAssureDx, for FDA review by the end of this year, which is a reiteration of the timeline that we communicated in our March and May shareholder letters. This means that we could begin marketing GraftAssureDx, the newest in our GraftAssure-branded family of products, upon FDA authorization as soon as   mid-2026.

Since our May 12^th^ shareholder letter, we have made consistent progress across three fronts:

First,<br> we have made steady strides with our GraftAssureDx kitted development, FDA submission preparation<br> and ongoing clinical trial:
We completed a productive meeting with the FDA on July 30. This meeting represented our<br> 3^rd^ overall meeting with the FDA regarding GraftAssureDx, and our second pre-submission<br> meeting. (A separate meeting that we had in the spring was not a formal pre-submission meeting<br> but an additional informational meeting.) We continue to be encouraged by our productive<br> dialogue with the FDA and our review team’s sincere guidance and engagement.
--- ---
Our clinicaltrials.gov listing includes top transplant hospitals: Our clinicaltrials.gov<br> listing became publicly accessible on July 15. It lists Mayo Clinic in Florida, Tampa<br> General Hospital, Cleveland Clinic, Vanderbilt University, and Intermountain Health as participating<br> in the trial. We expect to welcome additional trial partners, and we value the clinical expertise<br> and diverse patient populations that these leading transplant centers can contribute.
Weannounced our Vanderbilt University-based national principal investigator: On June 23^rd^, we announced that our national<br>principal investigator (NPI) for our ongoing trial to commercialize GraftAssureDx is Dr. Anthony J. Langone of Vanderbilt University<br>Medical Center. Dr. Langone will be presenting with iMDx for a webinar in which we will discuss our GraftAssure^TM^-branded<br>family of products. Please see further details below regarding this August 15th webinar event with Dr. Langone.
Medicare boosted reimbursement for our flagship technology to $2,753 per result: On May 19^th^,<br> we announced that Medicare boosted our reimbursement for the Lab Developed Test (LDT)<br> version of our assay, GraftAssureCore. The new rate sets a benchmark that can be used to<br> establish a reimbursement pathway for customers who purchase our future kitted test, GraftAssureDx.
--- ---
We published new head-to-head data that favorably compared our digital PCR-based test kits with NGS kits. We believe that our June 23^rd^ announcement of strong head-to-head<br> data regarding  our assay and another that is commercially available and widely<br> used in the U.S. will bode well for our marketing efforts to transplant hospitals as they<br> consider bringing testing in house. This data was presented at the European Renal Association<br> conference in Vienna in June, and at the European Society for Organ Transplantation Congress<br> in London later that month.
New data further confirmed the utility of dd-cfDNA and how we may differentiate by using digital PCR to measure it. We presented two abstracts at the World Transplant Congress<br> in San Francisco in August, including late-breaking data that potentially sets a new bar<br> for predicting graft rejection in kidney transplant patients. The late-breaking data showed <br> that iMDx offers the first digital PCR assay to combine relative and absolute measurements<br> of dd-cfDNA into single combined score, resulting in significantly improved positive predictive<br> values. Our proprietary combined score potentially broadens the clinical utility for dd-cfDNA<br> by generating fewer false positives than without such a combination, further reducing<br> unnecessary invasive biopsies for patients. We expect to further evaluate this combined score<br> in our ongoing FDA study (NCT07060716.) A separate abstract presented in San Francisco concluded,<br> “dd-cfDNA is the most eligible tool for noninvasive discrimination of rejection, since<br> it enables dynamic injury assessment.” This second set of data was selected for prominent<br> discussion during the closing plenary session.
MolDx began to establish clarity on surveillance testing: In a draft local coverage determination<br> (LCD) published on July 17, MolDx set a baseline for using cfDNA tests to surveil  <br> the kidney transplant patient population. (MolDx is a program run by Medicare to help decide<br> which genetic and molecular tests they will pay for and under what conditions.) We believe<br> that MolDx’s draft-recommended baseline of four monitoring tests in the first year<br> of a transplant and two tests per year thereafter will be compelling for hospital customers<br> seeking to bring testing in house. It’s helpful for us to receive clarity from MolDx,<br> even in draft form, and we do obviously expect the final LCD to be revised. (Please note<br> that MolDx’s draft surveillance levels align with our historical stated<br> total addressable market and investment thesis.) Beyond the surveillance baseline, the LCD<br> leaves room for additional testing for other causes. For instance, in January, we received<br> coverage expansion for additional testing of certain high-risk patients (those with<br> de novo donor-specific antibodies.) The final LCD, which may differ in what we believe<br> will be a more favorable direction, should allow us to communicate with clarity to our transplant<br> hospital customers about what base line level of surveillance testing will be covered for<br> their patients. Over time, as we demonstrate coverage expansion scenarios, we expect the<br> testing ratio per patient may even grow  .
Second,<br> our GraftAssureIQ research-use-only kit program continues to drive our “Land and Expand”<br> strategy in transplant:
--- ---
We sold our first GraftAssureIQ kits: In the second quarter, we received our first purchase<br> order for GraftAssureIQ research-use-only (RUO) kits from a major hospital in Switzerland.<br> While we’ve stated that we do not expect material revenue until we are selling our<br> Dx kits, the purchase of the IQ kits reflects a key proof point for our RUO pilot program.<br> These RUO customers are part of our “Land and Expand” strategy – where<br> we land research customers and help them become familiar with our assay, then expand<br> into selling high volumes of Dx kits upon regulatory clearance. This initial purchase was<br> of the first generation GraftAssureIQ kits that we began shipping as part of our<br> pilot program last year. Customers are now starting to validate in their labs using an improved<br> version, please see the next point.
--- ---
We began shipping our optimized assay in early June: As we noted in our March 2025 shareholder<br> letter, one of our three main goals this year was to finalize our kitted assay design,<br> which meant locking in ease-of-use improvements based on feedback from pilot site customers.<br> These pilot sites represent some of the most scientifically advanced labs in the world, which<br> have been using GraftAssure kits for research since mid-2024, and which we expect will be<br> among our expected initial clinical kit customers. We will be able to drive additional GraftAssureIQ<br> sales later this year, as our pilot sites validate the second generation assay.
Incremental data points for demand trended positively: After attending the 38th annual meeting of<br> the European Federation for Immunogenetics and Histocompatibility (EFI) conference in Prague<br> in May, about 70% of laboratory professionals who met with us asked for a follow up meeting<br> at the European Society for Organ Transplantation Congress in London from June 29 through<br> July 2. In addition, our first research-use-only pilot users of GraftAssureIQ are now producing<br> initial data sets, seeking to expand use cases for dd-cfDNA.
And<br> third, we continue to carefully invest in, and prepare for, new product pipeline:
--- ---
Our oncology pipeline gained momentum upon the signing of a non-binding development letter of intent: In May, we attended the American Society of Clinical Oncology conference in Chicago,<br> and solidified new potential strategic relationships related to our oncology assay pipeline.<br> Shortly after, we signed a development letter of intent with a major instrument maker regarding<br> our DetermaIO, immuno-oncology assay. This agreement lays the groundwork for a potential<br> strategic collaboration focused on delivering our assays more broadly and efficiently.
--- ---
Strengthening oncology IP with new colorectal cancer patent: We were thrilled<br> to be awarded U.S. Patent No. 12,359,252 B2 on July<br> 15, 2025, covering our method for detecting colorectal cancer using circulating nucleic<br> acid biomarkers. This patent reinforces our intellectual property around noninvasive cancer<br> detection and supports our strategy to expand into blood-based cancer diagnostics. Protecting<br> a method to identify colorectal cancer using cell-free DNA from a simple blood draw opens<br> the door for us for future screening tools that could broaden our clinical offerings and<br> create new oncology market opportunities.

Alsoin the second quarter, we renamed the company and moved our headquarters to Nashville: On June 17^th^, we renamed our company from Oncocyte to Insight Molecular Diagnostics. In his inaugural annual letter to shareholders, CEO Josh Riggs wrote,“While molecular diagnostic testing has advanced significantly in recent years, many times access remains limited — constrainedby geography, cost, and the need for centralized labs. Our mission is to democratize access to molecular diagnostic testing to improvepatient outcomes. We aim to lead in molecular diagnostics by doing what sets technology companies apart: developing proprietary algorithmsthat drive scalable value.” We also moved our headquarters from Irvine, Calif., to Nashville, Tenn., which is the home of our accredited lab.

What’snext?


We are highly focused on concluding our clinical trial and submitting GraftAssureDx  to the FDA to seek marketing authorization. We are aiming to submit to the FDA by the end of the year, representing no change from our prior communication, and we continue to tightly manage and monitor several interlocking work streams to support this timeline. It’s important to note that we don’t expect there to be significant delays between the close of our clinical trial and our FDA data submission, because our FDA data submission will be templated, which means that as the clinical trial results come in, we can drop the data into our template, perform quality checks and execute the submission.

Beyond that, we are not stopping at kidney. From 2026 to 2028, we see at least six potential areas for clinical and regulatory expansion of our dd-cfDNA kitted assays alone. These include monitoring therapeutic response to drugs that reduce immune-system-driven organ rejection, recurrence monitoring for kidney transplant rejection, indications using urine, and expansions into heart, lung, and liver transplant rejection testing. Each of these programs builds on the same cfDNA platform we’re already using and provides a path to expand how the test can be used to help more transplant patients.

Finally, we wanted to raise the curtain slightly on what we believe is a developing powerful and differentiated scientific story for our kitted assay, particularly with the World Transplant Congress data that we presented and future clinical data that we hope to publish. While we have communicated with shareholders all along that our kitted strategy is most likely to be successful thanks to shorter testing turn-around times and revenue generation for transplant centers, we also are starting to build a scientific case for why digital PCR, which is natively quantitative, can enable use cases for dd-cfDNA testing beyond what’s currently on the market.

So, with the necessary caveated prudence of not over-selling this point, we believe that the data points regarding both absolute quantification as well as relative quantification are exciting. We believe our kitted assay will enable testing over the life of the kidney transplant patient, from early detection of antibody-mediated rejection (AMR-based organ rejection), therapeutic efficacy for treating AMR (that is, monitoring whether the drugs to treat rejection are working), to an MRD-like recurrence monitoring model for organ rejection. (MRD, or minimum residual disease, testing is a term that is already well-known in the oncology sector and we believe our assay may enable a similar model in transplant.)

We look forward to continuing to update you on our scientific and commercial progress.

-The iMDx Management Team

Q22025 Financial Overview


Our<br> reported revenues of $518,000 in Q2 2025 were derived from laboratory services performed<br> at our clinical laboratory in Nashville and, nominally, from our first GraftAssureIQ kitted<br> products sale. We see our laboratory services revenue as a testament to our team’s<br> ability to achieve the on-time delivery of clear, scientifically sound, and accurate data<br> sets to our clients.
While <br> we have communicated that we do not expect material revenue on our kitted product sales until<br> after we have achieved regulatory clearance to market GraftAssureDx, we nevertheless are<br> pleased that a European transplant hospital customer purchased a small number of first-generation<br> research-use-only kits in the quarter. Notably and as communicated in our March update, we<br> began implementing workflow improvements to our RUO kits earlier this year, which we believe<br> delivers a better user experience and consolidates our lead in ease-of-use testing. However,<br> those workflow improvements have resulted in an intentional mitigation of RUO sales in the<br> short term. Our RUO customer sites are now validating the second generation kits,<br> and will be positioned to make additional RUO kit purchases later this year.
--- ---
Three<br> Months Ended<br> June 30, Six<br> Months Ended<br> June 30,
--- --- --- --- --- --- --- --- ---
2025 2024 2025 2024
(In<br> thousands)
Laboratory<br> Services $ 494 $ 104 $ 2,632 $ 258
Laboratory<br> Developed Test Services 22
Kitted<br> Products 24 24
Total $ 518 $ 104 $ 2,656 $ 280
We<br> reported gross profit of $350,000 in Q2 2025, representing a 67.6% gross margin — up<br> from 62% in Q1 2025. This margin expansion was primarily driven by operational efficiencies<br> achieved in our Nashville lab. Key contributors included a full quarter of automation and<br> workflow enhancements, enabling a higher number of samples to be processed per batch and<br> reducing labor cost per sample. Also benefitting gross margin was the fact that certain acquired<br> intangibles became fully amortized in Q1 2025 and those expenses, therefore, did not continue<br> in the second quarter.
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In<br> Q2 2025, operating expenses of $10.2 million included $2.8 million in a non-cash change in<br> the fair value of our contingent consideration, as well as $504,000 in non-cash stock-based<br> compensation expenses and $538    ,000 in non-cash depreciation and amortization<br> expenses. Excluding the impact of these non-cash charges, operating expenses increased 1%<br> sequentially over the first quarter, as we invested more heavily in our FDA program and sales<br> and marketing ahead of commercial launch, while finding offsets among general and administrative<br> expenses.
Research<br> and development expenses increased 12% sequentially at $3.3 million in the second quarter<br> reflecting increased investment in our kitted product development – including FDA-compliant<br> software development expenses, laboratory supplies, personnel and regulatory consulting fees.
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Sales<br> and marketing expenses grew 21 % sequentially to $1.5 million in the second quarter reflecting<br> go-to-market investments as we prepare for commercial launch, including marketing, advertising,<br> travel and personnel.
General<br> and administrative expenses declined 15% sequentially to $2.6 million in the second quarter<br> driven in part by cost discipline. The sequential decline in expenses was also due to the<br> fact that Q1 2025 included a one-time charge of $279,000 tied to realizing previously deferred<br> expenses in connection with the termination of our Sales Agreement pursuant to which we could<br> sell shares of our common stock in “at-the-market” offerings as defined in Rule<br> 415(a)(4) of the Securities Act.
Our<br> Q2 2025 net loss was $9.7 million, or ($0.30) per share.
--- ---
Our<br> Q2 2025 non-GAAP loss from operations was $5.98 million excluding certain non-cash items.<br> Please refer to the table below, “Reconciliation of Non-GAAP Financial Measure,”<br> for additional information.
Our<br> Q2 2025 per share results reflect 32.0 million weighted average shares outstanding and includes<br> the effects of 3.4 million pre-funded warrant shares that were issued in April 2024 and February<br> 2025 to a certain investor  . As of August 4, we had 28.6 million shares issued<br> and outstanding.
The<br> company’s cash, cash equivalents, and restricted cash balance at the end of the second<br> quarter was $26.0 million. This number includes the $28.7 million in net financing cash flow<br> from our registered direct offering and private placement in February 2025.
We<br> are pleased that our second quarter outgoing cash flow from operations (net cash used in<br> operating activities) of $6.3 million, combined with capital expenditures of $349,000, were<br> generally in line with our targeted quarterly average spend of $6 million, which was partially<br> a result of operational efficiency and partly a result of working capital management. As<br> communicated in March, we expected cash spend in the second and third quarters to fluctuate<br> above $6 million as we made incremental investments into our FDA program, some of which are<br> short-term in nature and which can be scaled down if desired after our FDA submission.
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Webcastand Conference Call Information


Live Zoom Call and Webcast on Monday, August 11, 2025, at 2:00 p.m. PT / 5:00 p.m. ET.

Those interested may access the live Zoom call by registering here:

Insight Molecular Diagnostics Q2 2025 Earnings Webinar.

Once registered, a confirmation email will be sent with instructions.

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

KOLCall on August 15, 2025:


Insight Molecular Diagnostics (iMDx) will host a virtual key opinion leader (KOL) event on Friday, August 15, 2025, at 4:00 PM ET featuring Anthony Langone, MD (Associate Professor of Medicine, Division of Nephrology and Hypertension, Vanderbilt University).

To register, click here.

AboutInsight 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.Insight Molecular Diagnostics.com/ for more information.

GraftAssureCore™, GraftAssureIQ™, GraftAssureDx™, VitaGraft™, GraftAssure™, DetermaIO™, and DetermaCNI™ are trademarks of Insight Molecular Diagnostics Inc.

Forward-LookingStatements


Anystatements 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 continued developmentof a regulated kitted assay, regulatory progress, ongoing clinical trial, upcoming webinar(s), the expected impact of MolDx’s finalLCD, the Company’s Land and Expand strategy, sales forecasts, product pipeline, and other statements about the future expectations,beliefs, goals, plans, or prospects expressed by management. Forward-looking statements involve risks and uncertainties, including, withoutlimitation, risks inherent in the development and/or commercialization of diagnostic tests or products, uncertainty in the results ofclinical trials or regulatory approvals, the capacity of Insight Molecular Diagnostics’ third-party supplied blood sampleanalytic system to provide consistent and precise analytic results on a commercial scale, potential interruptions to supply chains, theneed and ability to obtain future capital, maintenance of intellectual property rights in all applicable jurisdictions, obligations tothird 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 inherentin strategic transactions such as the potential failure to realize anticipated benefits, legal, regulatory or political changes in theapplicable jurisdictions, accounting and quality controls, potential greater than estimated allocations of resources to develop and commercializetechnologies, or potential failure to maintain any laboratory accreditation or certification. Actual results may differ materially fromthe results anticipated in these forward-looking statements and accordingly such statements should be evaluated together with the manyuncertainties 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, whichspeak only as of the date on which they were made. Insight Molecular Diagnostics undertakes no obligation to update such statements toreflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

InvestorContact:


Doug Farrell

LifeSci Advisors LLC

dfarrell@lifesciadvisors.com

- Tables Follow -

INSIGHTMOLECULAR DIAGNOSTICS INC.,

CONDENSEDCONSOLIDATED BALANCE SHEETS

(Inthousands)


December<br> 31,<br> 2024
(Unaudited)
ASSETS
CURRENT<br> ASSETS
Cash<br> and cash equivalents 24,287 $ 8,636
Accounts<br> receivable, net of allowance for credit losses of 5 and 16, respectively 512 1,613
Inventories 693 410
Deferred<br> financing costs 279
Prepaid<br> expenses and other current assets 1,350 821
Total<br> current assets 26,842 11,759
NONCURRENT<br> ASSETS
Right-of-use<br> and financing lease assets, net 2,524 2,757
Machinery<br> and equipment, net, and construction in progress 4,149 3,567
Intangible<br> assets, net 14,600 14,607
Restricted<br> cash 1,700 1,700
Other<br> noncurrent assets 702 691
TOTAL<br> ASSETS 50,517 $ 35,081
LIABILITIES<br> AND SHAREHOLDERS’ EQUITY (DEFICIT)
CURRENT<br> LIABILITIES
Accounts<br> payable 1,277 $ 2,279
Accrued<br> compensation 1,459 1,939
Accrued<br> royalties 1,116 1,116
Accrued<br> expenses and other current liabilities 571 418
Right-of-use<br> and financing lease liabilities, current 1,540 1,295
Contingent<br> consideration liabilities, current 689 228
Total<br> current liabilities 6,652 7,275
NONCURRENT<br> LIABILITIES
Right-of-use<br> and financing lease liabilities, noncurrent 1,834 2,369
Contingent<br> consideration liabilities, noncurrent 40,933 37,711
TOTAL<br> LIABILITIES 49,419 47,355
Commitments<br> and contingencies
SHAREHOLDERS’<br> EQUITY (DEFICIT)
Preferred<br> stock, no par value, 5,000 shares authorized; no shares issued and outstanding
Common<br> stock, no par value, 230,000 shares authorized; 28,617 and 17,453 shares issued and outstanding at June 30, 2025 and December 31,<br> 2024, respectively 367,965 338,244
Accumulated<br> other comprehensive income 85 21
Accumulated<br> deficit (366,952 ) (350,539 )
Total<br> shareholders’ equity (deficit) 1,098 (12,274 )
TOTAL<br> LIABILITIES AND SHAREHOLDERS’ EQUITY (DEFICIT) 50,517 $ 35,081

All values are in US Dollars.

INSIGHTMOLECULAR DIAGNOSTICS INC.,

UNAUDITEDCONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Inthousands, except per share data)


Three<br> Months Ended<br> June 30, Six<br> Months Ended<br> June 30,
2025 2024 2025 2024
Net<br> revenue $ 518 $ 104 $ 2,656 $ 280
Cost<br> of revenues 168 32 974 141
Cost<br> of revenues – amortization of acquired intangibles 22 7 44
Gross<br> profit 350 50 1,675 95
Operating<br> expenses:
Research<br> and development 3,281 2,453 6,205 4,765
Sales<br> and marketing 1,460 853 2,666 1,699
General<br> and administrative 2,647 2,407 5,762 5,080
Change<br> in fair value of contingent consideration 2,804 (1,031 ) 3,683 2,281
Impairment<br> loss on held for sale assets 169
Total<br> operating expenses 10,192 4,682 18,316 13,994
Loss<br> from operations (9,842 ) (4,632 ) (16,641 ) (13,899 )
Other<br> (expenses) income:
Interest<br> expense (25 ) (8 ) (54 ) (23 )
Other<br> income, net 125 110 282 263
Total<br> other income, net 100 102 228 240
Loss<br> before income taxes (9,742 ) (4,530 ) (16,413 ) (13,659 )
Income<br> taxes
Net<br> loss $ (9,742 ) $ (4,530 ) $ (16,413 ) $ (13,659 )
Net<br> loss per share:
Net<br> loss attributable to common stockholders - basic and diluted $ (9,742 ) $ (4,587 ) $ (16,413 ) $ (13,922 )
Net<br> loss attributable to common stockholders per share - basic and diluted $ (0.30 ) $ (0.36 ) $ (0.57 ) $ (1.32 )
Weighted<br> average shares outstanding - basic and diluted 32,023 12,870 28,876 10,567

INSIGHTMOLECULAR DIAGNOSTICS INC.,

UNAUDITEDCONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Inthousands)

Three<br> Months Ended<br> June 30, Six<br> Months Ended<br> June 30,
2025 2024 2025 2024
CASH<br> FLOWS FROM OPERATING ACTIVITIES:
Net<br> loss $ (9,742 ) $ (4,530 ) $ (16,413 ) $ (13,659 )
Adjustments<br> to reconcile net loss to net cash used in operating activities:
Depreciation<br> and amortization expense 559 304 1,043 617
Amortization<br> of intangible assets 22 7 44
Stock-based<br> compensation 504 386 977 804
Equity<br> compensation for bonus awards and consulting services 74 50 88 96
Change<br> in fair value of contingent consideration 2,804 (1,031 ) 3,683 2,281
Impairment<br> loss on held for sale assets 169
Changes<br> in operating assets and liabilities:
Accounts<br> receivable 3,028 76 1,101 399
Inventories (234 ) (283 )
Prepaid<br> expenses and other assets (124 ) 12 (189 ) (50 )
Accounts<br> payable and accrued liabilities (3,113 ) (1,240 ) (2,086 ) (386 )
Operating<br> lease assets and liabilities (35 ) (27 ) (65 ) (123 )
Net<br> cash used in operating activities (6,279 ) (5,978 ) (12,137 ) (9,808 )
CASH<br> FLOWS FROM INVESTING ACTIVITIES:
Machinery<br> and equipment purchases, and construction in progress (349 ) (191 ) (656 ) (215 )
Net<br> cash used in investing activities (349 ) (191 ) (656 ) (215 )
CASH<br> FLOWS FROM FINANCING ACTIVITIES:
Proceeds<br> from sale of common shares 15,807 29,143 15,807
Financing<br> costs to issue common shares (538 ) (487 ) (538 )
Redemption<br> of Series A redeemable convertible preferred shares (5,389 ) (5,389 )
Repayment<br> of financing lease obligations (114 ) (33 ) (212 ) (33 )
Net<br> provided by financing activities (114 ) 9,847 28,444 9,847
NET<br> CHANGE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH (6,742 ) 3,678 15,651 (176 )
CASH,<br> CASH EQUIVALENTS AND RESTRICTED CASH, BEGINNING 32,729 7,278 10,336 11,132
CASH,<br> CASH EQUIVALENTS AND RESTRICTED CASH, ENDING $ 25,987 $ 10,956 $ 25,987 $ 10,956

InsightMolecular Diagnostics Inc.,

Reconciliationof Non-GAAP Financial Measure

ConsolidatedAdjusted Loss from Operations


Note: In addition to financial results determined in accordance with U.S. generally accepted accounting principles (“GAAP”), this press release also includes a non-GAAP financial measure (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 / or intangible items that may obscure the underlying trends in the business. These non-GAAP financial measures, when viewed in a reconciliation to respective GAAP 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 measure to the most directly comparable GAAP measure:

Three<br> Months Ended
June<br> 30, March<br> 31, June<br> 30,
2025 2025 2024
(unaudited) (unaudited) (unaudited)
(In<br> thousands)
Consolidated<br> GAAP loss from operations $ (9,842 ) $ (6,799 ) $ (4,632 )
Stock-based<br> compensation 504 473 386
Depreciation<br> and amortization expenses 559 491 326
Change<br> in fair value of contingent consideration 2,804 879 (1,031 )
Consolidated<br> Non-GAAP loss from operations, as adjusted $ (5,975 ) $ (4,956 ) $ (4,951 )