Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to __________ Commission File Number: 1-37648 Insight Molecular Diagnostics Inc. (Exact name of registrant as specified in its charter) (Sta ...

Exhibit 99.1 IMDX Reports Q2 2025 Results and Momentum Toward GraftAssureDx Launch 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 amoun ...

Core Insights - Insight Molecular Diagnostics Inc. has rebranded from Oncocyte Corporation and relocated its headquarters to Nashville, Tennessee, with a new stock symbol "IMDX" effective June 18, 2025 [1][2][3] Company Strategy - The rebranding reflects the company's expanded strategic direction beyond oncology, now including a focus on transplant medicine, aiming to deliver a molecular diagnostic kit for kidney transplant patients [2][3] - The company targets a $1 billion addressable market for transplant rejection testing and is transitioning from product development to commercialization [3][4] Operational Changes - The relocation to Nashville aligns operations with the company's CLIA-certified lab and healthcare innovation hub, while maintaining a laboratory in Göttingen, Germany [4] - The company is unifying its transplant diagnostics under the GraftAssure brand, retiring the VitaGraft name [11][16] Product Development - The GraftAssure product line includes GraftAssureCore (lab-developed test), GraftAssureIQ (research-use-only kit), and GraftAssureDx (in vitro diagnostic kit in development) [11][12][16] - The company is actively participating in the European Society for Organ Transplantation (ESOT) Congress to promote its GraftAssureIQ pilot site program [7][9] Branding and Identity - The new logo symbolizes the company's commitment to healthcare providers and reflects its mission to provide insights through science [5][6] - The rebranding leverages existing rights to the name Insight Genetics, acquired in 2020, and emphasizes a healthcare provider-centric philosophy [5][6]

Core Insights - Oncocyte Corp. has announced a positive update regarding the pricing of its next-generation lab-developed test (LDT), GraftAssureCore, which enhances its position in the transplant rejection testing market and indicates potential growth in its estimated $1 billion total addressable market [1][6] Pricing and Reimbursement - The Centers for Medicare & Medicaid Services (CMS) has increased the reimbursement rate for GraftAssureCore to $2,753 per result, up from $2,222 for first-time testing and $1,029 for subsequent tests [2] - This new pricing aligns with existing competitive technologies and expands market appeal for future FDA-cleared kitted products at transplant centers [6] Company Strategy and Future Prospects - Oncocyte has invested significantly in improving the scalability and manufacturability of its workflow, which supports its kitted test program [3] - The new reimbursement rate establishes a benchmark for future kitted tests, such as GraftAssureDx, which is expected to be submitted for FDA review by the end of the year [3] - The company anticipates that receiving FDA authorization will enable broader adoption of its technology, allowing transplant centers to access high-quality, FDA-cleared kits with established reimbursement [4] Clinical Trials and Market Engagement - Oncocyte has received approval from a Central Institutional Review Board for its clinical trial, with final preparations underway at participating transplant centers [4] - The company expects participation from three of the top 10 U.S. transplant centers, representing nearly 10% of annual U.S. transplant volume [4] Technology and Market Position - Oncocyte's technology quantifies donor-derived cell-free DNA (dd-cfDNA), which has been established as a trusted biomarker for transplant rejection [5] - The company is rebranding its test portfolio under the GraftAssure brand, with GraftAssureCore being the new name for its previously marketed VitaGraft assay [5]

Financial Data and Key Metrics Changes - Pharma services revenue for the quarter was $2.1 million, exceeding expectations due to a large order processed quickly, resulting in $1.4 million invoiced just days before the quarter ended [16][17] - The company ended the first quarter with nearly $33 million in cash, including restricted cash, and reported a free cash flow of negative $6.2 million, aligning with the target average quarterly cash burn of $6 million [19][20] Business Line Data and Key Metrics Changes - The majority of revenue in Q1 came from a single corporate customer, which has led to potential partnership opportunities for one of the oncology assays [17] - The company has 10 sites running its research use only (RUO) assay across various regions, including the US, Germany, UK, Switzerland, Austria, and Southeast Asia [9][10] Market Data and Key Metrics Changes - The company expects to have 20 sites trained on its graft assay workflow by the end of the year, which is part of a strategy to land hospitals with the RUO product and expand to selling the clinical kitted product post-FDA clearance [9][12] - Interest from several university hospitals in the clinical trial has been noted, with expectations to include at least three of the top 10 transplant centers in the US [6][9] Company Strategy and Development Direction - The company is focused on finalizing its clinical assay and trial design, preparing for an FDA submission by the end of the year, and expanding its customer base in the transplant sector [5][8] - A corporate name change is planned to better reflect the strategic direction, moving away from the name OncoCyte, which no longer aligns with the company's primary focus on transplant [12][13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress made towards building a sustainable business in the transplant market, with increasing interest from potential corporate partners [15] - The company anticipates that the strong interest in the clinical trial will translate into future demand for its IVD assay [7][8] Other Important Information - The company is investing in improving and simplifying digital PCR workflows, which are seen as a differentiator compared to NGS, particularly for transplant centers with lower sample volumes [10][11] - The company is preparing for a significant increase in cash burn due to clinical trial costs and FDA-compliant software development [20] Q&A Session Summary Question: Can you expand on the larger revenue-generating pharma customer interested in oncology? - Management confirmed that the interest is related to DetermaIO and a kitted version, with potential for collaboration on immunotherapy response [24] Question: What are the next milestones for DetermaIO? - The company is looking forward to data from the SWOG study involving 800 patients, which is expected to be reported towards the end of the year [26][28] Question: What feedback has been received from US transplant centers regarding the study? - Management described the relationship with transplant centers as enthusiastic, with a strong desire for access to the technology [30] Question: How does the company view the impact of the IOTA model on market growth? - Management acknowledged skepticism from partners but remains hopeful for increased demand for testing tools as more marginal organs are used [39] Question: What is the focus for the upcoming Q-sub meeting with the FDA? - The focus will be on finalizing the submission and addressing specific questions from the FDA to ensure acceptance of the final submission [48]

Financial Data and Key Metrics Changes - Pharma services revenue for Q1 2025 was $2.1 million, exceeding expectations due to a large order processed quickly, with $1.4 million invoiced in the last few days of the quarter [16][17] - Gross margins for pharma services reached 62%, extending the company's cash runway and deepening customer relationships [16][17] - The company ended Q1 2025 with nearly $33 million in cash, including restricted cash, and reported a free cash flow of negative $6.2 million, aligning with the target average quarterly cash burn of $6 million [20][22] Business Line Data and Key Metrics Changes - The majority of revenue in Q1 came from a single corporate customer, which is now seeking partnership opportunities on one of the oncology assays [17] - The company has 10 sites running its research use only (RUO) assay across various countries, including the US, Germany, UK, Switzerland, Austria, and Southeast Asia [8][12] Market Data and Key Metrics Changes - The company expects to have 20 sites trained on its graft to share workflow by the end of 2025, which is part of a strategy to land hospitals with the RUO product and expand to selling the clinical kitted product post-FDA clearance [8][12] - Interest from several university hospitals in the clinical trial has been noted, with expectations to include at least three of the top 10 transplant centers in the US [6][8] Company Strategy and Development Direction - The company is focused on finalizing its clinical assay and trial design, preparing for an FDA submission by the end of 2025, and spring loading revenue for the second half of 2026 [5][6] - A strategic pivot has been made towards transplant diagnostics, with plans to unveil a new company name that reflects this direction [12][13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress made and the future potential of the transplant product, noting increased interest from corporate partners [15] - The company is optimistic about the FDA approval timeline, targeting the first half of 2026 for approval [8][21] Other Important Information - The company is investing in improving and simplifying digital PCR workflows, which are seen as a differentiator compared to NGS platforms [10][11] - The company plans to announce a new Nasdaq ticker alongside the name change, emphasizing a resource-conscious approach to capital allocation [22] Q&A Session Summary Question: Inquiry about the larger revenue-generating pharma customer and oncology interest - Management confirmed that the interest is related to DetermaIO and potential kitted versions, indicating unique advantages in tougher cancers [25] Question: Next milestones for DetermaIO - The focus is on the SWOG study involving 800 patients, with data expected towards the end of the year [28] Question: Feedback from US transplant centers regarding the study - Management reported enthusiasm from transplant centers, indicating a strong desire for in-house technology access [31] Question: Impact of the IOTA model on market growth - Management acknowledged skepticism from partners but noted that increased demand for testing is anticipated [41] Question: Potential friction between transplant centers and physicians regarding test orders - Management indicated that most centers allow physicians to choose tests, emphasizing the importance of demonstrating the technology's performance [45] Question: Final Q-sub meeting expectations - The company is on track for submission and has incorporated FDA feedback into the Q-sub [49]

Revenue Growth - Total net revenue increased to $2.1 million for the three months ended March 31, 2025, compared to $176,000 in the same period in 2024, representing a 1115% increase [212]. - Pharma Services revenue increased by $2.0 million, with revenue from one existing customer amounting to approximately $2.1 million during Q1 2025 [214]. Expenses - Research and development expenses rose by $612,000, driven by costs associated with the development of GraftAssureCore, GraftAssureIQ, DetermaIO, and DetermaCNI [214]. - Sales and marketing expenses increased by $360,000, primarily due to ramped-up activities related to the transplant business and oncology commercialization efforts [214]. - General and administrative expenses increased by $442,000, mainly due to higher personnel-related expenses and professional fees [214]. - Research and development expenses increased by 26% to $2.9 million for the three months ended March 31, 2025, compared to $2.3 million in the same period of 2024 [219]. - Sales and marketing expenses rose by 43% to $1.2 million for the three months ended March 31, 2025, up from $846,000 in the prior year [221]. - General and administrative expenses increased by 17% to $3.1 million for the three months ended March 31, 2025, compared to $2.7 million in 2024 [222]. Net Loss and Financial Position - The net loss for the three months ended March 31, 2025, was $6.7 million, a reduction of $2.5 million compared to a net loss of $9.1 million in the prior year [214]. - The net loss for the period was $6.7 million, with net cash used in operating activities amounting to $5.9 million [240]. - The company had an accumulated deficit of $357.2 million as of March 31, 2025 [229]. - Cash and cash equivalents stood at $31.0 million as of March 31, 2025 [229]. Financing Activities - A private placement in February 2025 raised approximately $29.1 million in gross proceeds, with net proceeds of approximately $28.7 million after expenses [211]. - The gross proceeds from the February 2025 Offering were approximately $29.1 million, with net proceeds of approximately $28.7 million after expenses [231]. Strategic Developments - The company received a positive coverage decision from MolDx for GraftAssureCore (Kidney) in August 2023, with commercial availability starting in January 2024 [203]. - The company confirmed Medicare reimbursement for monitoring certain high-risk patients in December 2024 [203]. - The company is focusing on commercializing its oncology product line, including DetermaIO, over the next 12 months [207]. - A global strategic partnership with Bio-Rad was established to collaborate on the development and commercialization of transplant products [234]. Contingent Consideration and Impairments - As of March 31, 2025, total contingent consideration liabilities were $38.8 million, up from $37.9 million as of December 31, 2024 [251]. - Stock-based compensation for the three months ended March 31, 2025, was $473,000, compared to $418,000 for the same period in 2024 [257]. - A total impairment of $41.9 million was recorded for certain oncology-related IPR&D intangible assets as of December 31, 2024 [253]. - An impairment loss of $169,000 was recognized on held for sale assets during the three months ended March 31, 2024 [254]. - The company established an allowance for credit losses of $36,000 as of March 31, 2025, compared to $16,000 as of December 31, 2024 [256]. Cash Flow and Investment Activities - Net cash used in operating activities amounted to $3.8 million, excluding noncash items totaling $4.0 million [241]. - Cash used in investing activities for the three months ended March 31, 2024, was $24,000 [242].

Exhibit 99.1 Oncocyte Reports Q1 2025 Results and Business Progress We're off to a fast and intensely focused start in 2025. Just two months ago, we shared our strategic outlook — and since then, we've remained heads down, executing. Our top priority is unchanged: bringing our first clinical molecular diagnostic test kit to market so that we may begin capturing value in the estimated $1 billion total addressable market for transplant rejection testing. The first quarter was defined by disciplined progress, ...

Core Insights - Oncocyte Corp. is focused on launching its first clinical molecular diagnostic test kit for transplant rejection testing, targeting a $1 billion market opportunity [1][8][25] - The company reported $2.1 million in pharma services revenue for Q1 2025, with gross margins improving from 40% in Q4 2024 to 62% in Q1 2025 due to operational efficiencies [2][31] Clinical Trial Progress - Oncocyte has completed the clinical trial design for its diagnostic testing kit and received approval from a central institutional review board (IRB) [4] - The company expects participation from at least three of the top 10 transplant centers in the U.S., which represent nearly 10% of U.S. transplanted organ volume [5][7] - The upcoming clinical trial is anticipated to meet clinical evidence requirements for FDA submission, with clearance expected in 2026 [8] Business Update - Ten leading transplant centers are currently using Oncocyte's GraftAssure research-use-only kits, with plans to expand to at least 20 centers by the end of 2025 [11] - The GraftAssure test is expected to generate annual revenue of several hundred thousand dollars up to $2 million per center once FDA clearance is achieved [11] - The company is rebranding its product portfolio, with GraftAssure becoming the umbrella brand for its dd-cfDNA test portfolio [24][22] Financial Overview - Q1 2025 revenues were $2.14 million, with a gross profit of $1.33 million, reflecting a 62% gross margin [31][36] - Operating expenses for Q1 2025 totaled $8.1 million, leading to a net loss of $6.7 million, or ($0.26) per share [31][36] - The company ended Q1 2025 with $32.7 million in cash and equivalents, bolstered by a recent financing round [31][38]

Company Announcement - Oncocyte Corp. will report its first quarter 2025 financial results after the market closes on May 12, 2025 [1] - A live Zoom webinar will be held at 2:00 p.m. PT on the same day to discuss the financial results [1][2] Investor Information - The webinar will include a Q&A session and requires registration for access [2] - An archived replay of the webinar will be available on Oncocyte's investor relations website after the call concludes [2] Company Overview - Oncocyte is a diagnostics technology company focused on democratizing access to novel molecular diagnostic testing to enhance patient outcomes [3]