The first question I consider when I think of a company in molecular diagnostics is whether it can translate complex science into a commercially viable business.Nabeel Bukhari is a law graduate with a specialization in company and corporate law, combined with self-taught expertise in financial analysis. He offers a unique perspective on business dynamics by integrating his legal knowledge with financial insights, making him a valuable asset in the financial realm. His work goes beyond traditional academics, ...

Investor Presentation NASDAQ:IMDX August 2025 iMDxinc.com Forward-Looking Statements Safe-Harbor Statement This presentation and the accompanying oral presentation contain "forward-looking" statements that are based on the Insight Molecular Diagnostics, Inc.'s (iMDx) management's beliefs and assumptions and on information currently available to management. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipate ...

Core Viewpoint - Exact Sciences (EXAS) has been upgraded to a Zacks Rank 1 (Strong Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system emphasizes the correlation between changes in earnings estimates and stock price movements, suggesting that an upward revision in earnings estimates can lead to increased buying pressure and higher stock prices [4][5]. - The Zacks Consensus Estimate for Exact Sciences has increased by 255.6% over the past three months, reflecting a strong positive trend in earnings outlook [8]. Zacks Rating System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [7]. - Only the top 5% of Zacks-covered stocks receive a "Strong Buy" rating, indicating superior earnings estimate revisions, which positions Exact Sciences favorably for potential market-beating returns [9][10].

Financial Data and Key Metrics Changes - Adjusted revenue for Q2 2025 was $90.5 million, representing a 14% year-over-year increase [8][26] - Adjusted EBITDA was $9.1 million, compared to an adjusted loss of $0.3 million in the previous year [8][31] - Cash collections accelerated to 105% of adjusted testing services revenue, with payment per test increasing across all tests and payer classes [22] Business Line Data and Key Metrics Changes - Adjusted testing services revenue was $66 million, up 14% year-over-year, with approximately 49,500 tests delivered, marking an 8th consecutive quarter of sequential testing volume growth [9][28] - Patient and Digital Solutions revenue was approximately $12.8 million, representing a 19% growth compared to last year [23][28] - Lab products revenue was $11.8 million, up 12% year-over-year, driven by sales of AlloSeq Tx kits [25][28] Market Data and Key Metrics Changes - Kidney testing volume grew nearly 20% year-over-year, with over 60 surveillance protocols implemented nationally [10][12] - Heart and lung testing also saw growth, although lung represents a smaller proportion of overall volume [45] - The company added 4.2 million new covered lives for AlloMap Heart, becoming an in-network provider with a large commercial health plan covering 1.2 million lives [17] Company Strategy and Development Direction - The company launched AlloSure Plus, an AI-driven diagnostic for kidney transplant monitoring, aiming to enhance clinical decision-making [11] - CareDx is focusing on expanding its market access strategy and evidence generation to support its products [15] - The company is improving its enterprise infrastructure and business processes to ensure revenue growth outpaces operating expenses [21] Management's Comments on Operating Environment and Future Outlook - Management reaffirmed the midpoint of 2025 revenue guidance, narrowing the range to $367 million to $373 million, with expectations of mid-teens growth in test volumes [8][32] - The draft LCD policy for molecular testing is viewed as a significant step forward, affirming coverage for surveillance testing [18] - Management expressed confidence in the operational excellence initiatives and the potential impact of the draft policy on future financial expectations [21][32] Other Important Information - Abhishek Jain announced his retirement as CFO, with Nathan Smith appointed as the new CFO [35][36] - The company is implementing Epic integration to enhance testing order processes and improve results delivery [21] Q&A Session Summary Question: Discussion on the LCD and potential headwinds - Management highlighted three focus areas for public comments: frequency testing, evidence supporting heart care, and bundled payments [40] Question: Data on heart and lung test volume growth - Heart and lung testing volumes grew, with continued positive trends in transplant volumes [45] Question: Changes to the long-range plan due to the draft LCD - No updates to the long-range plan will be provided until clarity on the final LCD is achieved [50] Question: Clarification on the $30 million headwind scenario - The $30 million headwind was calculated based on the attachment rate of heart care being over 90% [52] Question: Updated split on surveillance versus for-cause testing - There is a significant shift towards surveillance testing, but specific metrics are not being disclosed [56]

Core Viewpoint - Exact Sciences (EXAS) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive outlook for the company's earnings potential and stock price movement [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system is influenced by changes in earnings estimates, which are strongly correlated with near-term stock price movements [4][6]. - An increase in earnings estimates typically leads to institutional investors adjusting their valuations, resulting in buying or selling actions that affect stock prices [4]. Company Performance and Outlook - Exact Sciences is projected to earn $0.16 per share for the fiscal year ending December 2025, with no year-over-year change expected [8]. - Over the past three months, the Zacks Consensus Estimate for Exact Sciences has increased by 127%, reflecting a positive trend in earnings estimates [8]. Zacks Rating System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with only the top 20% receiving a "Strong Buy" or "Buy" rating [9][10]. - The upgrade of Exact Sciences to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10].

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]

Investment Highlights - Oncocyte is taking a disruptive approach to molecular diagnostic testing by empowering local labs with kits, contrasting the central lab model[14] - The company has secured a go-to-market strategic partner and equity investment[14] - Oncocyte has a science-driven team experienced in molecular diagnostics and rapid growth[14] - The company possesses a full R&D pipeline to fuel growth and portfolio expansion over the next decade[14] - Oncocyte's IP portfolio is attractive to partners and enables value protection[14] Transplant Market - Kidney transplant patients face a 20.2% chance of developing Antibody-Mediated Rejection (AMR) within 10 years of transplant, and up to 70% of those patients will progress to graft failure[43] - The US market supports $500 million in annual revenue for Laboratory Developed Tests (LDTs), which is currently generated by competitors[79] - The global transplant testing market is currently a $1 billion Total Addressable Market (TAM) and can expand to approximately $2 billion with claims expansion[67, 79] - Global transplants are growing at approximately 9% per year[68] Oncology Market - The estimated Total Addressable Market (TAM) for oncology in the US alone is $2 billion[97, 98] - The estimated Total Addressable Market (TAM) for Copy Number Instability (CNI) in the US Market is $4 billion[101] - There are 26 million estimated annual global testing opportunities for oncology[97] - There are 78 million estimated annual global testing opportunities for Copy Number Instability (CNI)[101]