3/25/2026

speaker
Conference Operator
Operator

Welcome to the QT Imaging Fourth Quarter 2025 Financial Results Conference Call. All participants will be in a 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 and then one using a telephone keypad. To withdraw your questions, you may press star and two. Please also note today's event is being recorded. At this time, I would like to turn the floor over to Jody Kane. Please go ahead.

speaker
Jody Kane
Investor Relations, Alliance Advisors IR

This is Jody Kane with Alliance Advisors IR. Thank you for participating in today's call. Joining me from QT Imaging are Dr. Reluka Dhanu, Chief Executive Officer, and Jay Jennings, Chief Financial Officer. I would like 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 the 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 an information currently available to QT imaging and related 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 QT imaging cloud platform and SAS model, performance of software enhancements, new product development and introductions, product sales growth, and projected revenues, and QT Imaging's industry and future events. For a list and description of 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 the live broadcast, March 25, 2026. QT Imaging disclaims any obligation, except as required by law, to update or revise any financial and 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?

speaker
Dr. Raluca Dinu
Chief Executive Officer, QT Imaging

Thank you, Jody. Good afternoon, everyone, and thank you for joining us for our second quarterly conference call. On behalf of our Board of Directors, management team, and everyone at QT Imaging, I would like to thank you for your interest in our company, And for those of you who are shareholders, we appreciate your support. This earnings call marks an important moment for QD imaging as we continue to build a new category in breast imaging, safe, volumetric, wave-based 3D imaging that delivers MRI-like information in a clinical and patient-friendly system. Our focus is execution, reliability, and commercial expansion in markets where access to advanced imaging has historically been limited. As we evolved from a hardware equipment company into a global data-driven platform, each exam is becoming an even richer source of quantitative AI-enabled insights that can inform care over time. I am proud of the transformation Qt Imaging achieved over the past year. In 2025, we exceeded our revenue target, increased scanner deployments, laid the foundation for our cloud SaaS platform, expanded internationally to new distribution partnerships and significantly strengthen our balance sheet. This progress reflects disciplined execution across our commercial and product strategies. The momentum has carried into 2026 as we continue building a stronger and more scalable business. Let's go over the progress and the vision in detail. To recap, our strategy is focused on addressing a significant gap in breast imaging. We are positioning our technology as a preferred screening solution for two key populations, intermediate-risk women and younger high-risk women under 40 identified through established risk assessment models. Together, these groups represent roughly 70% of the screening population when accounting for intermediate-risk patients and the large number of women with dense breast tissue who require enhanced screening approaches. This creates a substantial opportunity for increasing access to screening and improving clinical outcomes. Our imaging platform is designed specifically to perform well in dense breast tissue while capturing physiological information about the breast in a way that is close to MRI functional imaging. In a single exam, the system is able to capture multiple physiological biomarkers that reflect vascular, structural, and mechanical characteristics of the tissue. These biomarkers are derived directly from the imaging data itself rather than from laboratory or tissue testing. The result is what we described as one scan multiple biomarker approach that can provide clinicians with deeper functional insight while potentially reducing the need for additional follow-on tests. Beyond QT imaging breast acoustic CT scanner as an imaging system itself, we are building a precision diagnostic ecosystem around the platform using our SAS model, the QT Cloud Platform. This software environment analyzes the physiological biomarkers generated during each scan and converts them into quantitative clinical insights. By leveraging the geometric, elastic, and spectral properties of the tissue, capture dual imaging, the platform can support diagnostic interpretation, longitudinal monitoring, and clinical decision-making. Over time, this software layer is designed to continuously expand the clinical value of every scanner we deploy. Another important advantage of this system is workflow consistency. The imaging process is designed to be largely operator-independent, which reduces variability and helps produce more consistent imaging results across different sites and patient populations. From an economic perspective, the platform is designed to lower overall cost of imaging. It reduces capital equipment requirements, simplifies operations, and decreases reliance on highly specialized personnel. At the same time, it participates in existing reimbursement pathways for physiological imaging with potential incremental reimbursement opportunities tied to the advanced physiological insights generated through the software platform. Equally important is the patient experience. The system eliminates breath compression, ionizing radiation, and contrast injections. That makes the scan significantly more comfortable and less intimidating for patients. We believe this can improve adherence to screening programs, reduce anxiety associated with repeat imaging, and support more consistent long-time monitoring. Finally, because the modality is completely non-invasive and does not rely on radiation or contrast agents, it is particularly well-suited for therapy monitoring. Clinicians can perform scans more frequently without the limitation that exists with modalities such as mammography or MRI. That allows physicians to track treatment response more closely and potentially gain earlier insight into whether a therapy is working. Let's cover now our results and business partnerships. We entered 2026 with strong business and financial momentum, thanks to the many accomplishments our team delivered in 2025. I'm proud to report the last year we shipped 40 scanners, more than tripling the 12 scanners shipped in 2024. We also deliver record revenue of 18.9 million through passing our guidance of 18 million. These gains reflect the growing demand of our radiation-free, compression-free 3D breast imaging platform and heightened interest in our technology. Revenue growth in 2025 was primarily driven by our exclusive distribution agreement with our United States distribution partner, NXA Imaging, which is a wholly owned subsidiary of Canon Medical Systems USA. Last August, we expanded geographically, naming Gulf Medical as our exclusive partner for commercialization of the breast acoustic CT scanner in Saudi Arabia, leveraging their strong relationship with hospitals, clinics, and government health institutions. This partnership is expected to drive adoption across both public and private healthcare sectors and aligns with Saudi Arabia's ongoing investment in women's health and advanced imaging. Distribution partnerships like NXE Imaging and Golf Medical are central to our strategy of scaling the business while maintaining a capital-efficient model. In line with this strategy, we expanded our presence in the Gulf region this January through an exclusive distribution agreement with Al-Naghi Medical Company, a leading medical device distributor in the United Arab Emirates. This new agreement covers QT imaging breast acoustic CT scanners in our QTI cloud platform. The agreement calls for minimum order quantities totaling 43 scanners over three years, representing more than 24 million in minimum contracted revenue. We will continue to use the strategy of contracting for minimum order quantities to expand in other regions. In October, we entered into strategic collaboration with Intel Red Medical Systems, now GE, to enable seamless integration of QT imaging breast acoustic CT scanners with their secure cloud-based platform. IntelliRev is a global leader in medical imaging solutions, and their enterprise picture archiving and communication systems, PACS, and cloud backbone serves as the delivery infrastructure for the QTI cloud platform to support clinical and research deployments, facilitate secure data management, streamline workflows, and support integration into existing radiology IT environments. In January, we announced a partnership with Olea Medical to enhance the QTI cloud platform by integrating Olea Medical advanced visualization, quantitative analytics, and AI-ready imaging technologies to support clinical interpretation, research workflows, and quantitative imaging assessments. Olea Medical software uses advanced mathematical modeling and AI-assisted tools to generate robust imaging biomarkers visualizations. We believe this technology will further strengthen the clinical utility of our QD scans and enable future AI and machine learning applications. In regards to our regulatory applications and approvals, we have submitted our documentation to Saudi Arabia FDA, SFDA, for regulatory approval in Saudi Arabia, as well as to the Ministry of Health and Prevention for UAE regulatory approval. We received UAE regulatory approval on March 17th. We will continue the same regulatory strategy for other Gulf states. Later in the year, we plan to apply for CE-MARC regulatory approval for European extension. Additionally, this month, we have also received the FDA 510 clearance for an enhanced configuration of our breast imaging scanner. The updated system incorporates a tilted transmitter geometry that improves tomographic coverage of tissue close to the chest wall. This part of the body anatomy has been extremely challenging to capture with standard imaging approaches, and our enhanced design provides more complete posterior breast coverage and improved overall diagnostic utility. Regarding the reimbursement codes, in November 2025, we applied for a category three current procedure terminology, CPT code from the American Medical Association, which is designed to support emerging technologies and procedures while further evidence is gathered. On February 23rd, 2026, the American Medical Association CPT editorial panel approved a new category three CPT code for 3D quantitative transmission volumetric ultrasound tomography of the breast. The new Category 3 code, AX579T, represents a significant milestone in the clinical and commercial advancement of QT imaging technology, recognizing the distinct clinical evidence enabled by its radiation-free, compression-free 3D breast imaging platform. The new CPT code ensures standardized reporting of this emerging imaging service supporting data collection, utilization tracking, and continuing evaluation by clinicians, payers, and health systems. The code is scheduled for release on July 1, 2026, with an effective date of January 1, 2027. The reimbursement code will support adoption in hospitals. I'm happy to report a few major updates in our clinical studies. Firstly, Mayo Clinic prospective pilot study evaluated the effectiveness of QT scans compared with MRI as a supplemental screening tool for patients with a high risk of breast cancer. The study enrolled 26 women with an elevated lifetime risk of breast cancer, more than 20%, from July to October 2025. All patients underwent a bilateral breast MRI and QT scan, where the QT scan was performed within 30 days of the MRI. Images of both modalities were independently interpreted by four breast radiologists. This pilot study demonstrated a high absolute agreement between MRI and QT scans, suggesting their comparable effectiveness in identifying positive findings. Secondly, Sunnybrook Cancer Center prospective observational early validation study evaluated the use of QT scans in detecting, characterizing, and measuring the volume of breast masses in comparison to MRIs. QT scans demonstrated good performance in identifying relatively small tumors, multiple lesions, satellite lesions, intraductal extensions, and calcifications, as well as offering valuable diagnostic insights. MRI with contrast offered a broader distribution in size classification. In summary, the study found good overall agreement between MRI and QT scans for assessing breast mass volume. This result suggests that a QT scan could excel in specific diagnostic scenarios, particularly when evaluating advanced and multifocal disease and may serve as an important alternative breast imaging option when MRI is not feasible due to availability or patient contraindication. To report now on our cash position, we strengthen our balance sheet through an 18.2 million oversubscribed private placement that was completed in October. This financing was led by Style Capital with participation from other institutional and existing investors, positioning us to support continued growth and invest in our platform. We ended 2025 with $10.5 million in cash. We also made important progress at the corporate level. We successfully uplifted the trading of our common stock to the NASA Capital Market after meeting all applicable financial, corporate governance, and regulatory requirements. This is an important milestone that we believe expands our visibility and access to capsule markets, both now and in the future. We returned to NASDAQ after less than one year due to our very strong turnaround momentum. Regarding our team, we continue to strengthen our clinical and scientific expertise by naming the renowned breast cancer researcher, Dr. Marya Mashita, as medical advisor. Dr. Yamashita will support us across several key areas, including optimizing clinical integration, refining user experience, and ensuring that our technology not only meets but exceeds the expectations of clinicians and patients. Her deep experience in breast imaging and clinical research will be invaluable as we broaden our installed base and continue to generate data in both community and academic settings. We also continue to strengthen our operations teams. having recently hired the Vice President of Manufacturing and Vice President of Quality and Regulatory and plan to add the Vice President of Supply Chain and Production Planning. Regarding media and IR, recently we partnered with The Shift, which is an intergenerational interdisciplinary media platform featuring Gloria Steinman as their inaugural shift maker and cover star alongside other prominent women to broaden awareness of kids' imaging technology in our scanner as a safe, comfortable imaging modality, and to spotlight our growing global commercial momentum. This collaboration aligns our Women-Centered Radiation-Free Imaging Platform with the Shift Inflation Voice to help reach and educate women who shape conversations around health and innovation. As part of this partnership, I will participate in the Shift Makers Awards and Gala at Harvard University this week. Our advances in breast imaging will subsequently be featured in the SHIFT publication to further the education and impact for early detection and prevention, extending our message to a broader audience of women that would benefit from the QT imaging technology. Additionally, we engaged Alliance Advisor IR team to broaden our outreach to investors and enhance our presence in the capital market. Communicating our strategy execution and long-term value proposition more effectively supports our focus on establishing a shareholder base that fully understands and embraces our growth trajectory and the transformative potential of our technology. Now I'd like to turn the call to our CFO, Jay Jennings, to review financial results. Jay?

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