Prepared remarks
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 0. After today's presentation, there will be an opportunity to ask questions. Please note this event is being recorded. I would now like to turn the conference over to your host, Bruce Voss. With us on the call today are Dr. Raluca Dinu, Chief Executive Officer, and Jay W. 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 acoustic CT scanner including its product commercialization and manufacturing, the evolution of QT Imaging into a scalable imaging platform, a QT Imaging 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, 08/12/2026. QT Imaging disclaims any obligation to update this information because of new information, future events, or otherwise. And now I would like to turn the call over to Dr. Raluca Dinu. Raluca?
Thank you, Bruce, 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. Our breast acoustic CT imaging technology 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 a 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 United States shipment plan and generated revenue of $7.4 million, an increase of 103% compared to 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 the 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 health 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 Southeast, and Dave Reinhart as Vice President, Regional Sales. 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 NXT Imaging, a subsidiary of Canon Medical Systems, United States. By combining established distribution infrastructure with expanded direct commercial and business development capabilities, we are 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 Nadi Medical in the United Arab Emirates, together with our sales agent partnership with Re:Invent in Pakistan, provide a capital-efficient model for extending our commercial reach and supporting local market development. This partner-led approach enabled QT Imaging to leverage established sales and service infrastructure while building the foundation for broader international adoption of the 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 QT Imaging 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 that market. Together with our existing authorization in the United Arab Emirates, these milestones further extend our regulatory foundation across the Middle East and expand the markets in which we can commercialize the breast acoustic CT platform. 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 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 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's approval of a dedicated Category III CPT reimbursement code for our imaging modality. The code was released on July 1st 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-trained surgical oncologist and breast surgeon, and Dr. George Telinger, a Mayo Clinic-trained radiologist and early adopter of our imaging modality in his imaging center. Their complementary expertise is helping us strengthen 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 might be reproducible across systems, locations, and operators to reliably measure changes in breast tissue over time. We believe that these 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 the supplemental imaging setting. The study reported breast-level agreement between QT Scan and MRI and the identification by 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 the 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, an 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 these programs are building a 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. Software version 4.5.0 improved the spatial resolution of breast acoustic CT reflection imaging, providing radiologists with greater image detail 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 quarter on productization of the Olea Viewer as an advanced modality imaging solution for the 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, collaboration with Intellirad provides the secure cloud and PACS infrastructure supporting image management, clinical and research connectivity, and enterprise deployment of QT Imaging's precision pathway. Building on this infrastructure, we continue to advance the QT Imaging 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 diverse scanners with software and cloud-based capabilities to enhance the value of each system across the installed base. In July, we announced the successful completion of our first routine FDA inspection since the inception of the company with zero Form FDA 483 observations. 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 entered 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 2.5x our current operational space while reducing the lease cost per square foot by approximately 55%. Put another way, we are more than doubling our real estate footprint at a comparable cost. This investment expands our manufacturing capacity, improves operating efficiency, and provides the infrastructure needed to support future commercial growth. Presenting 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, these achievements demonstrate we are building the commercial, clinical, regulatory, and operational foundation needed to support broader adoption of the 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 are 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 installed 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 W. Jennings, to review our financial results. Jay?
Thank you, Raluca, and good afternoon, everybody. Revenue for the second quarter of 2026 was $7.4 million, an increase of 103% compared with $3.7 million for the second quarter of 2025. The increase was primarily attributable to the shipment of 15 breast acoustic CT scanners in the 2026 quarter compared with eight in the prior-year quarter. Gross margin was 41% for the second quarter of 2026 compared with 50% for the second quarter of 2025. The gross margin for the second quarter of 2026 was in line with our projections for sales in the United States. The higher prior-year gross margin reflected a lower weighted-average cost of inventory sold. Total operating expenses for the second quarter of 2026 were $4.9 million compared with $2.9 million a year ago, with the increase reflecting higher employee compensation and benefits, professional service costs, and marketing expenses. Operating loss for the second quarter of 2026 was $1.9 million compared with an operating loss of $1.0 million for the second quarter of 2025 and $2.3 million for the first quarter of 2026. The net loss for the second quarter of 2026 was $11.1 million compared with a net loss of $4.0 million for the second quarter of 2025. The second quarter 2026 net loss included an $8.3 million non-cash loss on debt extinguishment and modification associated with the amendment of our senior secured term loan with Lynrock Lake. Accounts receivable was $7.4 million as of June 30, 2026, primarily from the shipment of 15 scanners during June 2026, compared to $5.8 million as of December 31, 2025, primarily from the shipment of 12 scanners during December 2025. The $7.4 million accounts receivable was paid during the beginning of August 2026. Accordingly, as of August 7, 2026, cash and restricted cash totaled approximately $14.2 million compared with approximately $11.0 million as of June 30, 2026. Please see our Form 10-Q filed earlier today for further details regarding our second quarter and first half financial results. During the quarter, we amended our credit agreement with Lynrock Lake, extending the maturity date of the $10.1 million senior secured term loan by two years from March 31, 2027 to March 31, 2029, and increasing the interest rate from 10% per annum to 12% per annum. Now turning to 2026 financial guidance. We are affirming our expectation for revenue of approximately $39 million for the year, more than double 2025 revenue. This guidance is based on the expected shipment of scanners under distributor minimum order quantities as well as expected contributions from our direct sales efforts. And now I will turn the call back to Raluca.
Thank you, Jay. As we look ahead, we believe QT Imaging is entering an important next phase. We have demonstrated commercial growth, expanded our United States and international infrastructure, strengthened our clinical and regulatory foundation, and continue to advance the QT Imaging platform. Our priorities for the remainder of 2026 are clear: 1) Accelerate commercial adoption and installed base growth; 2) Strengthen our clinical and scientific evidence; 3) Expand global market access; 4) Advance our quantitative imaging platform; and 5) Continue scaling the business with operational discipline. We believe execution across these priorities positions us well as we move towards 2027 and continue building QT Imaging into a leading quantitative breast imaging company. Thank you for your interest in QT Imaging and for your continued support. With that, we are ready to take questions. Operator?
Questions and answers
We will now begin the question-and-answer session. If at any time your question has been addressed and you would like to withdraw the question, you may do so. Our first question comes from Jeffrey Cohen with Ladenburg Thalmann. Please go ahead.
Good afternoon, Raluca and Jay. Hope you are doing well. We have got a few questions. So I guess, firstly, you did mention Pakistan at the beginning of the call. Could you bring us up to speed on what is going on there?
Hi, Jeffrey. Thank you so much for joining the call. Great to hear you. So we do have a sales agent agreement in Pakistan with a woman-led company that is called Re:Invent. We do have a few systems and they will hopefully go in the next few months to that geography. FDA clearance is appropriate for Pakistan, so we do not need an additional regulatory clearance. But that is the plan, Jeffrey. Thank you so much for asking.
Okay. Got it. And then could you talk about U.S. and the back half of the year and commercial activity as well as your direct commercial efforts internally and how that may work domestically with QT Imaging as well as with NXT Imaging in the U.S.?
Absolutely. So we are executing against our plan for shipments in the United States. We shipped this quarter 15 scanners, and we do plan to ship another 15 scanners and 17, respectively, in Q3 and Q4 in the United States, obviously through a very strong partnership with NXT Imaging. We did move on, as we discussed last quarter, with us starting to strengthen our direct sales team. We do see progress with our direct sales team selling into at least two segments: imaging centers and hospitals. It is more of a solution sale, a technical and clinical sale in those segments. Thus, we have brought in two very experienced sales VPs to cover the East Coast and the West Coast. We are not going to continue to hire up until we get our feet on the ground and the two sales managers start selling and growing the business in the United States. We do plan to have our direct sales taking on more responsibility in 2027 and ahead, with ongoing support from NXT and other distribution partners as we move into 2027. Did I answer your question?
Yeah. Perfect. Couple more if I may. Cadence on back-half placements for this year, would you expect a ramp through Q3 and Q4? Or would you expect them to be fairly even?
Jeffrey, I had a hard time hearing the beginning of your question.
Could you please repeat?
Back-half placements for the year, Q3 versus Q4, would you expect a gradual increase through the next two quarters or even?
No, no. We do expect an increase in the placements in Q3 and Q4, and our team will help the NXT team through that.
Got it. Okay. One for Jay, if I may, Jay. Back-half OpEx, is that $5 million number going to be fairly flat for the second half of the year per quarter?
Yes. We anticipate it going up a little bit with the hiring of the sales team as well as shifting of some of the clinical studies expenses from the first half of the year into the second half of the year.
Got it. Okay. And then lastly, Raluca, you mentioned QT versus MRI, 100-patient study. Is that a new study? And what do you expect to derive from that as far as coding or reimbursement down the road?
So yes, it is a new study at Mayo, and we are looking toward the results for the following: 1) to make sure that all the findings from MRI are discovered by QT, and 2) to reduce the number of biopsies by reducing BI-RADS 4 findings to BI-RADS 3. If a woman is BI-RADS 3 category, there is no need for her to get a biopsy. So that is the goal for that study. All this data would be recorded under the Category III CPT reimbursement code starting on 01/01/2027.
Okay. So you would not expect any additional or add-on codes to the Category III starting in January?
Not for now. We have to start recording all the data against our code, Jeffrey, before we can improve or add to the reimbursement strategy.
Okay. And then lastly for us, the facility in Petaluma, have you 100% completely moved to that facility or are you still operating the two?
In Petaluma? No, we are operating out of the two. Very good question. We got the key for the facility this week. It will take us about a month to a month and a half to be moved completely there. We do plan to finish production in our Novato facility so we do not interrupt the shipments for Q3 and then have our shipments for Q4 out of the Petaluma facility.
Perfect. That does it for us. Thanks for taking the questions.
No, thank you so much. I appreciate it.
Thank you very much. Our next question comes from Benjamin Haynor with Lake Street Capital Markets. Please go ahead.
Good afternoon, Raluca and Jay. Thanks for taking the questions.
Hi, Benjamin. Thank you so much for being on our call. Thank you so much for listening to us.
No problem. First off, just kind of following up on the direct salesforce. It sounds, if I am hearing you correctly, that you will, excuse me, begin to add some additional folks as sales materialize beyond the gentlemen that you recently hired. Am I hearing you correctly there?
So, Benjamin, thanks for asking. We now have three very senior sales people that have joined the team. We are set up in Salesforce, we have leads, and we have operational backend sales organization. These guys are extremely experienced and they will start bringing in opportunities through 2026. I do not foresee any additions to the team in 2026 for two reasons: number one, we are trying to keep track of our operational costs, and number two, the strategic direction for the team was to collect enough information about the two market segments that these direct salespeople will address — the imaging centers and the functional medicine space — to know exactly what we need to hire in 2027 if we so decide.
Okay. Got it. That is helpful. And then congrats on the Israeli clearance. Just wondering what the commercialization strategy is there. I mean, is that something where you do it yourself? Do you sign a distribution agreement? And then the study that you have planned there sounds like high risk longitudinal data — any more detail on how many women, how long on the data, what that would be? Great to hear.
Absolutely. We are extremely pleased that Rambam Healthcare Campus has accepted our offer for a clinical study. We are going to focus exactly as you said on high-risk women and a longitudinal study, but also on trying to understand the standard of care in Israel and what else can be added with our technology within their standard of care. Those are the two dimensions for the clinical study. To answer your question about commercialization, we are exploring a relationship with a distributor in Israel. We would like to go through that path, and we will report back in the next call. The plan is to have a partnership with a distributor in Israel.
Okay. Got it. And then any more countries in the works beyond Israel, Pakistan, and the existing Gulf states?
So, Benjamin, we are trying to stay away from the areas impacted by conflict. We are looking into Bahrain and Qatar. These are two additional countries for us to seek regulatory approval. Certainly we are focused on building the business in Saudi Arabia, the UAE, and Israel. But those are the next two, Qatar and Bahrain. And then we will focus on CE Mark and MDR for next year.
Okay. Got it. And then just, I do not know if there is anything more you can share on utilization on the installs that you are seeing: is utilization sticking to the same level or any movement there? What can you tell us?
So we do see a slow move; it is never as fast as we want for implementation of the scanners or getting the scanners all the way to the customer. This is why Satrajit and his two hires will focus on helping NXT. NXT is making progress on having the scanners at the customers, but we do feel that even for the functional medicine space, we need to help. For the next five months, we will focus on helping NXT get all those scanners at the customers.
Okay. Excellent. Well, thank you so much for taking the questions, and congrats on all the progress.
I appreciate it. Thank you so much, and thank you for taking the time to be with us.
This concludes our question-and-answer session. I would like to turn the conference back over to Dr. Raluca Dinu for closing remarks.
Thank you very much. I want to thank everyone for joining us today and for your continuing interest in QT Imaging. We are energized by our progress and remain focused on disciplined execution during the second half of the year. We look forward to discussing our continued progress during our next conference call when we report third quarter results. Until then, have a nice evening. Thank you so much.
The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.