QTI QT Imaging Holdings, Inc.

NASDAQ
$2.88

QT Imaging Holdings, Inc. Q2 F2026 Earnings Call Transcript

Wednesday, August 12, 2026

AI Conference Call Analysis

Sign in or subscribe to read.
Operator
Conference Operator
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.
Tirth Patel
Investor Relations (Core IR)
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?
Dr. Raluca Dinu
Chief Executive Officer
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?
Jay Jennings
Chief Financial Officer
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 the 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 Linrock Lake. Accounts receivable was $7.4 million as of June 30th, 2026, primarily from the shipment of 15 scanners during June 2026, compared to $5.8 million as of December 31st, 2025, primarily from the shipment of 12 scanners during December 2025. The accounts receivable as $7.4 million was paid during the beginning of August 2026. Accordingly, as of August 7th, 2026, cash and restricted cash totaled approximately $14.2 million compared with approximately $11.0 million as of June 30th, 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 Linrock 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'll turn the call back to Raluca.
Dr. Raluca Dinu
Chief Executive Officer
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. One, accelerate commercial adoption and installed-based growth. Two, strengthen our clinical and scientific evidence. Three, expand global market access. Four, advance our quantitative imaging platform. And five, to continue scaling the business with operational discipline. We believe execution across these priorities position us well as we move towards 2027 and continue building the 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?
Operator
Conference Operator
We will now begin the question and answer session. To ask a question, you may press star then 1 on your telephone keypad. If you were using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw the question, please press star then 2. At this time, we will pause momentarily to assemble our roster. Our first question comes from Jeffrey Cohen with Leidenberg Talman. Please go ahead.
Jeffrey Cohen
Analyst, Ladenburg Thalmann
Good afternoon, Raluca and Jay. Hope you're doing well. We've 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's going on there?
Dr. Raluca Dinu
Chief Executive Officer
Hi, Jeff. 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's called Reinvent. And we do have a few systems that will hopefully go in the next few months towards that geography. FDA clearance is appropriate for Pakistan, so we do not need an additional regulatory clearance. But that is the plan, Jeff. Thank you so much for asking.
Jeffrey Cohen
Analyst, Ladenburg Thalmann
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 few commercial ads internally and how that may work domestically with QT as well as with NXT in the U.S.?
Dr. Raluca Dinu
Chief Executive Officer
Absolutely. So we are executing against our plan for shipments in the United States. So we ship this quarter 15 scanners and we do plan to ship another 15 scanners and 17 respectively from Q3 and Q4 in the United States, obviously through very strong partnership with NFC Imaging. We did move on as we discussed last quarter, Jeff, with us starting to strengthen our direct sales team. We do see progress with our direct sales team selling into at least two segments, definitely imaging centers and hospitals. It is more of a solution sale, a technical sale, clinical sale in those segments. Thus, we have brought in the two very experienced sales VPs to cover the East Coast and the West Coast. We are not going to continue higher 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 the responsibility in 2027 and ahead. Obviously with the support from NXE and other distribution partners as we move into 2027. Did I answer your question?
Jeffrey Cohen
Analyst, Ladenburg Thalmann
Yeah, perfect. A 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?
Dr. Raluca Dinu
Chief Executive Officer
Jeff, I had a hard time hearing the beginning of your question. Could you please repeat?
Jeffrey Cohen
Analyst, Ladenburg Thalmann
Back half placements for the back half of the year, Q3 versus Q4, would you expect a gradual increase? through the next two quarters or even? No, no.
Dr. Raluca Dinu
Chief Executive Officer
We do expect an increase in the placement in Q3 and Q4, and our team will help an exit team through that.
Jeffrey Cohen
Analyst, Ladenburg Thalmann
Got it. Okay. One for Jay, if I may, Jay. Back half OPEX, is that $5 million number? are going to be fairly flat for the second half of the year per quarter.
Jay Jennings
Chief Financial Officer
Yeah, 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.
Jeffrey Cohen
Analyst, Ladenburg Thalmann
Got it. Okay. And then Lastly, Raluca, you mentioned a 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?
Dr. Raluca Dinu
Chief Executive Officer
So, Jeff, it's a new study at Mayo, and what we're looking towards and we're looking at the results is the following. Number one, to make sure that all the findings from MRI are discovered by QT. And second, to reduce the number of biopsies. So reducing the BI-RADS 4 findings to BI-RADS 3. If the woman is a BI-RADS 3 category, there's no need for her to get the biopsy. So that's the goal for that study. All this data would be recorded under the Category 3 CPT code, reimbursement code, starting on January 1, 2027. Okay.
Jeffrey Cohen
Analyst, Ladenburg Thalmann
So you would not expect any additional or add-on codes to the Cat 3 starting in January?
Dr. Raluca Dinu
Chief Executive Officer
Not for now. Not for now. We have to start recording all this data against our code just before we can improve or add to the reimbursement strategy.
Jeffrey Cohen
Analyst, Ladenburg Thalmann
Okay, and then lastly for us, the facility in Temecula, have you 100% completely moved to that facility or you're still operating the two?
Dr. Raluca Dinu
Chief Executive Officer
No, we're operating the two. Very good question. We are operating the two. We got the key for the facility this week. It will take us about a month, a month and a half to be moved completely there. We do plan to finish just the Our next question comes from Ben Hainer with Lake Street Capital Markets. Please go ahead.
Ben Hainer
Analyst, Lake Street Capital Markets
Good afternoon, Raluca and Jay. Thanks for taking the questions.
Dr. Raluca Dinu
Chief Executive Officer
Hi, Ben. Thank you so much for being in our call. Thank you so much for listening to us.
Ben Hainer
Analyst, Lake Street Capital Markets
No problem. First off, just kind of following up on the direct sales force, it sounds, if I'm hearing you correctly, that you'll begin to add some additional folks as sales materialize from the gentleman that you've recently hired at Am I hearing you correctly there? And then I know you provided quite a bit of detail on, you know, who the targets are, but is there anything else worth sharing on kind of the direct sales strategy?
Dr. Raluca Dinu
Chief Executive Officer
So, Ben, thanks for asking. So we have now three very senior sales guys who joined the team. We got ourselves set up in Salesforce. We have leads and we got ourselves operational from the back end of the sales, organizing the sales. These guys are extremely experienced and they'll start bringing in opportunities through 2026. I do not foresee any additions to the team in 2026 for two reasons. Number one, we're trying to keep track of our operational costs, obviously. And the second one, the request, the strategic direction from the team was to collect enough information about the two market segments that this direct sales guide will address. The imaging centers and the hospitals. And obviously still selling into the functional medicine space. We absolutely respect that segment too. But to get all the data points and know exactly what we need to hire in 2027 if we so decide.
Ben Hainer
Analyst, Lake Street Capital Markets
Okay. Got it. That's helpful. And then, you know, congrats on the Israeli clearance. Just wondering what the commercialization is. I mean, is that something where you do yourself? Do you sign a distribution agreement? Then the study that you have planned there, it sounds like high risk, longitudinal data, any more, how many women, how long on the data? That'd be great to hear.
Dr. Raluca Dinu
Chief Executive Officer
Absolutely. So, Ben, yes, we are extremely pleased with the fact that Rambam Hospital has accepted our offer for a clinical study. We are going to focus exactly as you said on high-risk women and 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. These are the two dimensions for the clinical study. But to answer your question, we are exploring a relationship with a distributor in Israel. We would like to go through that, and we'll report back in the next call. The plan is to do have a partnership with a distributor in Israel.
Ben Hainer
Analyst, Lake Street Capital Markets
Okay, got it. On international, I guess any more countries in the works beyond, you know, Israel, Pakistan, they eventually call on the existing kind of Gulf states.
Dr. Raluca Dinu
Chief Executive Officer
So, Ben, we're trying to stay away from the missiles and the conflict there. We are looking into Bahrain and Qatar. These are the two additional countries for us to seek regulatory approval. and certainly now we are focused on building the business in Saudi Arabia, UAE and Israel. But that's the next two, Qatar and Bahrain and then we'll focus on CE and MDR for next year.
Ben Hainer
Analyst, Lake Street Capital Markets
Okay, got it. And then just I don't know if there's any more you can share or anything you can share on Kind of the utilization on the installs that you are seeing is still kind of stick at the same kind of level. Any movement there? What can you tell us?
Dr. Raluca Dinu
Chief Executive Officer
So we do see a slow move. It's never as fast as we wanted, Ben, of implementation of the scanners or sharing of the scanners all the way to the customer. This is why Satrajit and he's Two hires will focus on helping NXC. NXC 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. And for the next six, sorry, five months, we will focus on helping NXC having all those scanners at the customers.
Ben Hainer
Analyst, Lake Street Capital Markets
Okay. Excellent. Well, thank you so much for taking the questions and congrats on all the progress.
Dr. Raluca Dinu
Chief Executive Officer
I appreciate it. Thank you so much and thank you for taking the time to be with us.
Operator
Conference Operator
This concludes our question and answer session. I would like to turn the conference back over to Dr. Raluca Dinu for closing remarks.
Dr. Raluca Dinu
Chief Executive Officer
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 our quarter results. Until then, have a nice evening. Thank you so much.
Operator
Conference Operator
The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.