Full Press Release Details
Reports Q2 2025 Results and Momentum Toward GraftAssureDx Launch
| Reiterating timelines for FDA submission in 2025 | ||
| Transplant clinical trial has attracted leading transplant hospitals | ||
| Booked first revenue from first-generation GraftAssureIQ research-use-only kits; began shipping second generation kits in June |
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:
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.
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.
is our belief that if we do the hard work of designing a lab test in a kitted form and achieve regulatory authorization, then
we will not only democratize access to these tests - thereby bringing care closer to the patient and helping hospitals to operate
more sustainably - but also create a rapidly growing, high-margin, recurring revenue business model.
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.
our May 12th shareholder letter, we have made consistent progress across three fronts:
| We completed a productive meeting with the FDA on July 30. This meeting represented our 3 rd overall meeting with the FDA regarding GraftAssureDx, and our second pre-submission meeting. (A separate meeting that we had in the spring was not a formal pre-submission meeting but an additional informational meeting.) We continue to be encouraged by our productive dialogue with the FDA and our review team's sincere guidance and engagement. | ||
| Our clinicaltrials.gov listing includes top transplant hospitals: Our clinicaltrials.gov listing became publicly accessible on July 15. It lists Mayo Clinic in Florida, Tampa General Hospital, Cleveland Clinic, Vanderbilt University, and Intermountain Health as participating in the trial. We expect to welcome additional trial partners, and we value the clinical expertise and diverse patient populations that these leading transplant centers can contribute. | ||
| We announced our Vanderbilt University-based national principal investigator: On June 23 rd , we announced that our national principal investigator (NPI) for our ongoing trial to commercialize GraftAssureDx is Dr. Anthony J. Langone of Vanderbilt University Medical Center. Dr. Langone will be presenting with iMDx for a webinar in which we will discuss our GraftAssure TM -branded 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 , we announced that Medicare boosted our reimbursement for the Lab Developed Test (LDT) version of our assay, GraftAssureCore. The new rate sets a benchmark that can be used to 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 data regarding our assay and another that is commercially available and widely used in the U.S. will bode well for our marketing efforts to transplant hospitals as they consider bringing testing in house. This data was presented at the European Renal Association conference in Vienna in June, and at the European Society for Organ Transplantation Congress 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 in San Francisco in August, including late-breaking data that potentially sets a new bar for predicting graft rejection in kidney transplant patients. The late-breaking data showed that iMDx offers the first digital PCR assay to combine relative and absolute measurements of dd-cfDNA into single combined score, resulting in significantly improved positive predictive values. Our proprietary combined score potentially broadens the clinical utility for dd-cfDNA by generating fewer false positives than without such a combination, further reducing unnecessary invasive biopsies for patients. We expect to further evaluate this combined score in our ongoing FDA study (NCT07060716.) A separate abstract presented in San Francisco concluded, "dd-cfDNA is the most eligible tool for noninvasive discrimination of rejection, since it enables dynamic injury assessment." This second set of data was selected for prominent discussion during the closing plenary session. | ||
| MolDx began to establish clarity on surveillance testing: In a draft local coverage determination (LCD) published on July 17, MolDx set a baseline for using cfDNA tests to surveil the kidney transplant patient population. (MolDx is a program run by Medicare to help decide which genetic and molecular tests they will pay for and under what conditions.) We believe that MolDx's draft-recommended baseline of four monitoring tests in the first year of a transplant and two tests per year thereafter will be compelling for hospital customers seeking to bring testing in house. It's helpful for us to receive clarity from MolDx, even in draft form, and we do obviously expect the final LCD to be revised. (Please note that MolDx's draft surveillance levels align with our historical stated total addressable market and investment thesis.) Beyond the surveillance baseline, the LCD leaves room for additional testing for other causes. For instance, in January, we received coverage expansion for additional testing of certain high-risk patients (those with de novo donor-specific antibodies.) The final LCD, which may differ in what we believe will be a more favorable direction, should allow us to communicate with clarity to our transplant hospital customers about what base line level of surveillance testing will be covered for their patients. Over time, as we demonstrate coverage expansion scenarios, we expect the testing ratio per patient may even grow . |
| We sold our first GraftAssureIQ kits : In the second quarter, we received our first purchase order for GraftAssureIQ research-use-only (RUO) kits from a major hospital in Switzerland. While we've stated that we do not expect material revenue until we are selling our Dx kits, the purchase of the IQ kits reflects a key proof point for our RUO pilot program. These RUO customers are part of our "Land and Expand" strategy - where we land research customers and help them become familiar with our assay, then expand into selling high volumes of Dx kits upon regulatory clearance. This initial purchase was of the first generation GraftAssureIQ kits that we began shipping as part of our pilot program last year. Customers are now starting to validate in their labs using an improved version, please see the next point. | ||
| We began shipping our optimized assay in early June: As we noted in our March 2025 shareholder letter , one of our three main goals this year was to finalize our kitted assay design, which meant locking in ease-of-use improvements based on feedback from pilot site customers. These pilot sites represent some of the most scientifically advanced labs in the world, which have been using GraftAssure kits for research since mid-2024, and which we expect will be among our expected initial clinical kit customers. We will be able to drive additional GraftAssureIQ 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 the European Federation for Immunogenetics and Histocompatibility (EFI) conference in Prague in May, about 70% of laboratory professionals who met with us asked for a follow up meeting at the European Society for Organ Transplantation Congress in London from June 29 through July 2. In addition, our first research-use-only pilot users of GraftAssureIQ are now producing initial data sets, seeking to expand use cases for dd-cfDNA. |
| 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, and solidified new potential strategic relationships related to our oncology assay pipeline. Shortly after, we signed a development letter of intent with a major instrument maker regarding our DetermaIO, immuno-oncology assay. This agreement lays the groundwork for a potential strategic collaboration focused on delivering our assays more broadly and efficiently. | ||
| Strengthening oncology IP with new colorectal cancer patent: We were thrilled to be awarded U.S. Patent No. 12,359,252 B2 on July 15, 2025 , covering our method for detecting colorectal cancer using circulating nucleic acid biomarkers. This patent reinforces our intellectual property around noninvasive cancer detection and supports our strategy to expand into blood-based cancer diagnostics. Protecting a method to identify colorectal cancer using cell-free DNA from a simple blood draw opens the door for us for future screening tools that could broaden our clinical offerings and create new oncology market opportunities. |
in the second quarter, we renamed the company and moved our headquarters to Nashville: On June 17th, 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 - constrained
by geography, cost, and the need for centralized labs. Our mission is to democratize access to molecular diagnostic testing to improve
patient outcomes. We aim to lead in molecular diagnostics by doing what sets technology companies apart: developing proprietary algorithms
that drive scalable value." We also moved our headquarters from Irvine, Calif., to Nashville, Tenn., which is the home of our
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.
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.
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.
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
2025 Financial Overview
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| (In thousands) | ||||||||||||||||
| Laboratory Services | $ | 494 | $ | 104 | $ | 2,632 | $ | 258 | ||||||||
| Laboratory Developed Test Services | - | - | - | 22 | ||||||||||||
| Kitted Products | 24 | - | 24 | - | ||||||||||||
| Total | $ | 518 | $ | 104 | $ | 2,656 | $ | 280 |
| We reported gross profit of $350,000 in Q2 2025, representing a 67.6% gross margin - up from 62% in Q1 2025. This margin expansion was primarily driven by operational efficiencies achieved in our Nashville lab. Key contributors included a full quarter of automation and workflow enhancements, enabling a higher number of samples to be processed per batch and reducing labor cost per sample. Also benefitting gross margin was the fact that certain acquired intangibles became fully amortized in Q1 2025 and those expenses, therefore, did not continue in the second quarter. | ||
| In Q2 2025, operating expenses of $10.2 million included $2.8 million in a non-cash change in the fair value of our contingent consideration, as well as $504,000 in non-cash stock-based compensation expenses and $538 ,000 in non-cash depreciation and amortization expenses. Excluding the impact of these non-cash charges, operating expenses increased 1% sequentially over the first quarter, as we invested more heavily in our FDA program and sales and marketing ahead of commercial launch, while finding offsets among general and administrative expenses. |
| Research and development expenses increased 12% sequentially at $3.3 million in the second quarter reflecting increased investment in our kitted product development - including FDA-compliant software development expenses, laboratory supplies, personnel and regulatory consulting fees. | ||
| Sales and marketing expenses grew 21 % sequentially to $1.5 million in the second quarter reflecting go-to-market investments as we prepare for commercial launch, including marketing, advertising, travel and personnel. | ||
| General and administrative expenses declined 15% sequentially to $2.6 million in the second quarter driven in part by cost discipline. The sequential decline in expenses was also due to the fact that Q1 2025 included a one-time charge of $279,000 tied to realizing previously deferred expenses in connection with the termination of our Sales Agreement pursuant to which we could sell shares of our common stock in "at-the-market" offerings as defined in Rule 415(a)(4) of the Securities Act. |
| Our Q2 2025 net loss was $9.7 million, or ($0.30) per share. | ||
| Our Q2 2025 non-GAAP loss from operations was $5.98 million excluding certain non-cash items. Please refer to the table below, "Reconciliation of Non-GAAP Financial Measure," for additional information. | ||
| Our Q2 2025 per share results reflect 32.0 million weighted average shares outstanding and includes the effects of 3.4 million pre-funded warrant shares that were issued in April 2024 and February 2025 to a certain investor . As of August 4, we had 28.6 million shares issued and outstanding. | ||
| The company's cash, cash equivalents, and restricted cash balance at the end of the second quarter was $26.0 million. This number includes the $28.7 million in net financing cash flow from our registered direct offering and private placement in February 2025. |
and Conference Call Information
Zoom Call and Webcast on Monday, August 11, 2025, at 2:00 p.m. PT / 5:00 p.m. ET.
interested may access the live Zoom call by registering here:
Molecular Diagnostics Q2 2025 Earnings Webinar.
registered, a confirmation email will be sent with instructions.
replay of the Zoom call will be available on the company's website shortly after the call.
Call on August 15, 2025:
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).
register, click here.
Insight Molecular Diagnostics, Inc.
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.
GraftAssureIQ , GraftAssureDx , VitaGraft , GraftAssure , DetermaIO , and DetermaCNI are trademarks
of Insight Molecular Diagnostics Inc.
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 continued development
of a regulated kitted assay, regulatory progress, ongoing clinical trial, upcoming webinar(s), the expected impact of MolDx's final
LCD, 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, 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.
MOLECULAR DIAGNOSTICS INC.,
CONSOLIDATED BALANCE SHEETS
| June 30, 2025 | December 31, 2024 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | $ | 24,287 | $ | 8,636 | ||||
| Accounts receivable, net of allowance for credit losses of $5 and $16, respectively | 512 | 1,613 | ||||||
| Inventories | 693 | 410 | ||||||
| Deferred financing costs | - | 279 | ||||||
| Prepaid expenses and other current assets | 1,350 | 821 | ||||||
| Total current assets | 26,842 | 11,759 | ||||||
| NONCURRENT ASSETS | ||||||||
| Right-of-use and financing lease assets, net | 2,524 | 2,757 | ||||||
| Machinery and equipment, net, and construction in progress | 4,149 | 3,567 | ||||||
| Intangible assets, net | 14,600 | 14,607 | ||||||
| Restricted cash | 1,700 | 1,700 | ||||||
| Other noncurrent assets | 702 | 691 | ||||||
| TOTAL ASSETS | $ | 50,517 | $ | 35,081 | ||||
| LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIT) | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payable | $ | 1,277 | $ | 2,279 | ||||
| Accrued compensation | 1,459 | 1,939 | ||||||
| Accrued royalties | 1,116 | 1,116 | ||||||
| Accrued expenses and other current liabilities | 571 | 418 | ||||||
| Right-of-use and financing lease liabilities, current | 1,540 | 1,295 | ||||||
| Contingent consideration liabilities, current | 689 | 228 | ||||||
| Total current liabilities | 6,652 | 7,275 | ||||||
| NONCURRENT LIABILITIES | ||||||||
| Right-of-use and financing lease liabilities, noncurrent | 1,834 | 2,369 | ||||||
| Contingent consideration liabilities, noncurrent | 40,933 | 37,711 | ||||||
| TOTAL LIABILITIES | 49,419 | 47,355 | ||||||
| Commitments and contingencies | ||||||||
| SHAREHOLDERS' EQUITY (DEFICIT) | ||||||||
| Preferred stock, no par value, 5,000 shares authorized; no shares issued and outstanding | - | - | ||||||
| Common stock, no par value, 230,000 shares authorized; 28,617 and 17,453 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively | 367,965 | 338,244 | ||||||
| Accumulated other comprehensive income | 85 | 21 | ||||||
| Accumulated deficit | (366,952 | ) | (350,539 | ) | ||||
| Total shareholders' equity (deficit) | 1,098 | (12,274 | ) | |||||
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIT) | $ | 50,517 | $ | 35,081 |