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8/12/2026
Welcome to the QT Imaging Second Quarter 2026 Financial Results Conference Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star, then 2. Please note, this event is being recorded. I would now like to turn the conference over to your host, Tirth Patel, Investor Relations. Please go ahead.
Thank you. This is Tirth Patel with Core IR. Thank you for participating in today's call. Joining me from QT Imaging are Dr. Raluca Dinu, Chief Executive Officer, and Jay Jennings, Chief Financial Officer. I want to remind listeners that comments made during this call by management will include forward-looking statements within the meaning of federal securities laws. Any statements that are not statements of historical facts should be deemed to be forward-looking statements. Such statements involve known and unknown risks, uncertainties, and other factors that may cause actual results, performance, or achievements to be materially different from those implied by such statements. All forward-looking statements are based on QT Imaging's current beliefs as well as assumptions made by and information currently available to QT Imaging and relate to, among other things, QT Imaging's Breast Acoustics CT Scanner, including its product commercialization and manufacturing, the evolution of QT Imaging into a scalable imaging platform, the QCI Cloud Platform and SAS model, performance of software enhancements, New Product Development and Introduction, and Product Sales Growth and Projected Revenues. For a list and description of the risks and uncertainties associated with the company's business, please see its filings with the Securities and Exchange Commission. Furthermore, the content of this call contains information that is accurate only as of the date of this live broadcast, August 12th, 2026. QT Imaging disclaims any obligation except as required by law to update or revise any financial or operational projections or other forward-looking statements, whether because of new information, future events, or otherwise. And now, I'd like to turn the call over to Dr. Raluca Dinu. Raluca?
Thank you, Terrence, and good afternoon, everyone. Thank you for spending time with us and for your interest in QT imaging. The second quarter was another strong period of execution for QT imaging as we continued to scale our commercial business and built the foundation for broader adoption of breast acoustic CT imaging technology. Our mission is to transform breast health by giving women and physicians a better approach to breast imaging. Today's pathway still has important limitations. Mammography can be less effective in dense breasts and requires compression. MRI can be costly and burdensome, and conventional ultrasound remains highly operator-dependent. QT Imaging was built to address these challenges with a differentiated, three-dimensional imaging platform that is radiation-free, compression-free, and quantitative. Our vision extends beyond delivering better imaging experience. We are building a platform designed to provide objective, reproducible information They can support more personalized breast health management and over time enable quantitative biomarkers and AI-driven applications. During the quarter, we shipped 15 Breast Acoustic CT scanners in line with our United States shipment plan and generated revenue of $7.4 million, an increase of 103% compared with the second quarter of 2025. For the first six months of 2026, we shipped 28 scanners and generated $14 million in revenue, compared to 14 scanners and $6.5 million in revenue during the same period last year. To put that growth in perspective, QT Imaging generated no revenue in 2023, $4.9 million in revenue in 2024, and $18.9 million in 2025. With our 2026 revenue guidance of approximately $39 million, we believe this trajectory demonstrates the continued scaling of our commercial business and the growing adoption of breast acoustic CT imaging modality. Most importantly, more than 12,000 women have now been imaged using breast acoustic CT scans today. For us, that milestone is about more than the growth of our installed base. It represents a growing body of real-world clinical experience with our technology and progress toward our ultimate objective, expanding access to a more patient-centered, quantitative approach to breast imaging. As we enter the second half of the year, our focus is increasingly on translating this foundation into broader adoption. Let me start with our United States commercial strategy. In the United States, we continue to strengthen the commercial infrastructure needed to support our next phase of growth. Under the leadership of our chief commercial officer, Satrajit Misra, we expanded our United States commercial organization with the appointment of Jason Dyer, our vice president regional sales east, and Dave Reinhart as vice president regional sales west. This expanded team strengthens our ability to engage directly with breast imaging centers clinicians, and Enterprise Health Systems, while continuing to leverage our exclusive distribution partnership with NXE Imaging, a subsidiary of Canon Medical Systems United States. By combining established distribution infrastructure with expanded direct commercial and business development capabilities, we're building a scalable commercial model designed to deepen customer engagement, accelerate clinical adoption, and installed base growth. and support sustainable long-term revenue growth and margin extension. Internationally, we continue to expand our commercial infrastructure through experienced regional partners with established market presence, local relationships, and deep knowledge of their healthcare systems. Our distribution partnerships with Gold Medical in Saudi Arabia and Al Nassi Medical in United Arab Emirates, together with our sales agent partnership, ReInvent Pharma in Pakistan, provide a capital efficient model for extending our commercial reach and supporting local market development. This partner-led approach enables QT imaging to leverage established sales and service infrastructure while building the foundation for broader international adoption of breast acoustic CT imaging modalities. While geopolitical developments have impacted commercial activity in parts of the Gulf region, we are beginning to see encouraging signs of renewed customer engagement, supported by our regulatory authorization and distributor partnerships. On the regulatory front, we continue to expand our international commercial foundation. We received clearance from the Saudi Food and Drug Authority, SFDA, for the QTI Breast Acoustic CD Scanner, enabling us to market and sell our technology in Saudi Arabia. More recently, we received a MAR authorization from the Ministry of Health in Israel, enabling commercialization of the breast acoustic CT scanner in the market. Together with our existing authorization in the United Arab Emirates, these milestones further strengthen our regulatory foundation across the Middle East and expand the market in which we can commercialize breast acoustic CT platforms. The first breast acoustic CT scanner in Israel is going to Rambam Healthcare Campus to support a planned clinical study in women with hereditary risk for breast cancer. This study provides an important opportunity to evaluate our radiation-free, compression-free quantitative imaging technology in a high-risk population where longitudinal imaging is particularly important and to generate additional evidence supporting its potential role in personalized breast health management. During the quarter, we also strengthened our balance sheet to a $10 million underwritten public offering. In addition, we amended our senior secured term loan with Lynn Rock Lake, extending the maturity date by two years. Together, this action provides additional financial flexibility as we continue to execute our commercial, clinical, and strategic initiatives. During the first half of this year, we secured two FDA clearances that expanded the capabilities of the Breast Acousticity System, including an enhanced scanner configuration that improves posterior breast imaging coverage and software functionality supporting volumetric measurements for lesion doubling time assessment. These enhancements reinforce QT imaging strategy of continuously expanding the platform through innovation in both hardware and software. A critical milestone during the first half of the year was the American Medical Association approval of a dedicated Category 3 CPT reimbursement code for our imaging modality. The code was released on July 1st and becomes effective January 1st, 2027. It provides a standardized mechanism for reporting, utilization tracking, and data collection, and importantly, creates the framework to build the clinical and health economic evidence that can support future coverage decisions. We continue to strengthen the clinical expertise, supporting the adoption of the Breast Acousticity Platform. Our clinical advisory board includes leaders across breast imaging, breast surgery, and clinical practice, including Dr. Mary Yamashita of USC Keck School of Medicine, Dr. Barry Roseman, an MD Anderson-trained surgical oncologist and breast surgeon, and Dr. George Tellinger, a Mayo Clinic-trained radiologist and early adopter of our imaging modality in his imaging center. Their complementary expertise is helping us strengthen physician education, clinical implementation and reader training as we support broader clinical adoption. Additionally, we announced results from a multi-site study Evaluating the repeatability and reproducibility of quantitative measurements generated by the Breast Acoustics CT platform. The results demonstrated less than 1% variability in speed of sound measurements across scanners under the study conditions. This level of consistency is important because quantitative imaging biomarkers might be much We believe that this results reinforce the potential of our imaging platform to provide objective, reproducible, quantitative information for longitudinal breast health management and precision breast care. As reported previously, Mayo Clinic conducted a prospective feasibility study evaluating QT scan in a supplemental imaging setting. The study reported breast level agreement between QT scan and MRI, and the identification of QT scan of all lesions considered suspicious on MRI. These pilot findings support the rationale for a second study involving more than 100 patients, which is expected to begin in the coming months. We are also advancing a prospective clinical study with Dr. Barry Roseman to evaluate the breast acoustic CT technology in a diagnostic breast imaging pathway. This study will compare QT scan with established breast imaging modalities and, where available, pathology with the goal of generating real-world clinical evidence supporting the diagnostic performance and broader adoption of our technology. At Sunnybrook, ongoing 100-patient clinical study is evaluating QT scan versus MRI, and under our NIH contract, clinical work is evaluating advanced quantitative ultrasound findings in relation to treatment response in women receiving neoadjuvant chemotherapy. Together, the programs are building complementary body of evidence across diagnostic performance, high-risk populations, quantitative reproducibility and treatment response monitoring, Supporting our broader objective of establishing the breast acoustic CT imaging modality as a clinically validated quantitative breast imaging platform. Innovation remains an important area of focus during the quarter. Softer version 4.5.0 improved the spatial resolution of breast acoustic CT reflection imaging, providing radiologists with greater imaging for detailed and clear visualization of breast anatomy and tissue structures while maintaining processing time designed to support an efficient clinical workflow. Our collaboration with Olea Medical was focused during the productization of the QT Olea Viewer as an advanced modality imaging solution for breast acoustic CT platform. The Viewer is being developed to provide physicians with an integrated environment for image visualization Correlation with other imaging modalities, quantitative assessment, and longitudinal patient evaluation while supporting more efficient clinical workflows. In parallel, our collaboration with IntelliRAD provides a secure cloud and tax infrastructure supporting image management, clinical and research connectivity, and enterprise deployment of QT imaging precision pathway. Building on its infrastructure, we continue to advance the QTI precision pathway, cloud platform to support secure image management, clinical collaboration, quantitative analysis, software development, and future AI-enabled applications. Our strategy is to build a platform that combines the breast acoustic CT scanner with software and cloud-based capabilities to enhance the value of each system across the installed database. In July, We announced the successful completion of our first routine FDA inspection since the inception of the company with zero form FDA 483 observation. The inspector provided positive feedback regarding the organization of our quality management system and the responsiveness of our team. We believe this exceptional outcome reflects the quality culture we are building and the strength of the systems and processes supporting the manufacturing and commercialization of our technology. During the quarter, we enter into an agreement to relocate our headquarters and manufacturing operations into a new 22,000 square foot facility in Petaluma, California. As reported previously, the new facility will provide more than two and a half times our current operational space while reducing the lease cost per square foot by approximately 55%. Put another way, we're more than doubling our real estate footprint at the comparable cost. This investment expands our manufacturing capacity, improves operating efficiency, and provides the infrastructure needed to support future commercial growth. Threatening our scientific leadership is an ongoing priority. We recently appointed Dr. Julia Albright as our Chief Science Officer. Julia brings more than three decades of leadership experience across medical imaging, healthcare technology, artificial intelligence, and enterprise software. In her role, she is helping align our scientific strategy, product innovation, engineering, and clinical programs as we advance the QT imaging platform. Collectively, this achievement demonstrates that we are building the commercial, clinical, regulatory, and operational foundation needed to support broader adoption of breast acoustic CT platform. As we look toward 2027, Our focus is increasingly on accelerating adoption, expanding our installed base, and leveraging the commercial infrastructure we are building today to support sustainable growth and margin expansion. At the same time, as we mentioned previously, our vision extends beyond the breast acoustic CT scanner itself. We're building a quantitative breast imaging platform that brings together advanced hardware, software, cloud infrastructure, and over time, Quantitative Biomarkers, and AI-Enabled Clinical Applications. We believe this platform has the potential to increase the value of our growing install base while providing physicians with objective, reproducible information to support more personalized breast health management. And now, I will turn the call over to our CFO, Jay Jennings, to review our financial results. Jay?
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