QT Imaging Holdings, Inc. Common Stock 2026 Q2 Earnings Call

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 Acoustic CT scanner, including its product commercialization and manufacturing, the evolution of QT Imaging into a scalable imaging platform, the QTI Cloud Platform and SaaS 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 12, 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. Now I'd like to turn the call over to Dr. Raluca Dinu. Raluca? Thank you, Thurif, 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 build 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 that 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 U.S. shipment plan and generated revenue of $7.4 million, an increase of 103% compared with the second quarter of 2025. For the first 6 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 to date. 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 U.S. commercial strategy. In U.S., we continue to strengthen the commercial infrastructure needed to support our next phase of growth.

Under the leadership of our Chief Commercial Officer, Satyajit Misra, we expanded our U.S. 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 NXC Imaging, a subsidiary of Canon Medical Systems U.S.A., Inc. 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 expansion. 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 Gulf Medical in Saudi Arabia and Al Nahdi Medical in United Arab Emirates, together with our sales agent partnership of Re-invent 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 modality. 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 CT™ scanner, enabling us to market and sell our technology in Saudi Arabia.

More recently, we received AMAR 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 markets in which we can commercialize Breast Acoustic CT platform. The first Breast Acoustic CT scanner in Israel is going to Rambam Health Care 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 through a $10 million underwritten public offering.

In addition, we amended our senior secured term loan with Lynrock Lake, extending the maturity date by two years. Together, these actions provide 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 Acoustic CT 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's 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 III CPT reimbursement code for our imaging modality. The code was released on July 1 and becomes effective January 1, 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 Acoustic CT 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 Cancer Center-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 Acoustic 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 must be reproducible across systems, locations, and operators to reliably measure changes in breast tissue over time. We believe that this result 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 QTscan in a supplemental imaging setting. The study reported breast level agreement between QTscan and MRI, and the identification of QTscan 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 QTscan 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 studies evaluating QTscan 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, these 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 remained an important area of focus during the quarter.