Welcome to the QT Imaging 3rd 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, and to withdraw your question, please press star then two. Please note, today's event is being recorded. I'd now like to turn the conference over to your host, Tirth Patel, with Investor Relations. Please go ahead.

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. These relate to, among other things, commercialization and manufacturing of the Breast Acoustic CT Scanner, the QTI Precision Pathway Cloud Platform, software development, reimbursement and clinical evidence initiatives, commercial distribution, international shipments, product sales growth, and projected revenue, including the 2026 Revenue Outlook. 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 the live broadcast, November 10, 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. We will also refer to certain non-GAAP measures during the call. The definitions of these measures and reconciliations to the most directly comparable gap measures are available in today's earnings release. And now, I'd like to turn the call over to Dr. Raluca Dinu. Raluca?

Thank you, Ter. Good afternoon, everyone. Our third quarter results demonstrate the progress we are making in commercializing our breast acoustic CT imaging modality. Revenue was $7.3 million, an increase of 75% year over year, and we sold 15 scanners compared to nine a year ago. For the first nine months, revenue reached $21.3 million compared to $10.7 million last year, and the scanner sales increased to 43 from 23. This results reflect meaningful growth. Our next responsibility is to translate that growth into broader clinical adoption. I want to discuss today our execution in four areas. One, U.S. commercialization. Two, clinical adoption and reimbursement. Three, technology and operational scale. And four, international expansion and financial discipline. First, commercial execution. Our U.S. commercial business continued to gain momentum during the third quarter, supported by a stronger direct sales organization, a significantly expanded pipeline of qualified opportunities nationwide, and the receipt of our purchase orders directly from customers across the country. We strengthened our commercial leadership structure with the three sales leaders now reporting directly to our Chief Commercial Officer, Satrajit Misra. This expanded organization is improving our ability to engage customers, advance opportunities through the sales cycle, and convert growing market interest into purchase orders. These developments represent important progress in building a scalable U.S. commercial operation and expanding our market presence. In parallel, we continue working with our distribution partner, NXE Imaging, a subsidiary of Canon Medical Systems USA, to improve customer placement, strengthen service execution, and drive greater commercial effectiveness. As we finalize our 2027 commercial structure, we are focused on accelerating sales growth, strengthening customer relationships, and establishing clear accountability across both our direct sales organization and the distribution channel. Looking ahead to 2027, our current domestic distribution agreement with NXA Imaging runs through the end of this year. We are engaged in constructive discussions with NXC and Canon Medical Systems USA regarding our future commercial relationship and scanners with the precision pathway SAS platform purchase commitments. While the new agreement has not yet been finalized, we are encouraged by the progress and see opportunities to strengthen collaboration as we expand into hospitals and imaging centers. An important part of our U.S. commercial strategy is expanding access to large hospital networks and integrating healthcare systems. We also made significant progress in expanding our access to United States hospitals and health systems through Premier, Inc., one of the nation's largest healthcare group purchasing organization, or GPO. Our breast acoustic CT technology was recognized at Premier Supplier Innovation Celebration following evaluation by a national committee of clinicians and healthcare supply chain experts. Building on this recognition in October, our distribution partner, Annex Imaging, secured a national group purchasing agreement with Premier, providing access to nearly 4,400 hospitals and health systems nationwide. The agreement establishes pre-negotiated pricing and purchasing terms, simplifying procurement for participating providers. This significantly expands our commercial reach. Our focus now is to convert this access into purchase orders and scanner installation. Second, clinical adoption and reimbursement. On November 4th, just a few days back, we achieved a major reimbursement milestone when the Centers for Medicare and Medicaid Services, or CMS, reversed its earlier proposed non-payment decision and established separate Medicare hospital outpatient payment for diagnostic QT scan examination effective January 1, 2027. Under the final 2027 Medicare rule, CMS assigned our dedicated CPT billing code 1079-T to ambulatory payment classification 5522 with payment status indicator S. Importantly, CMS recognized that physician-ordered QT scan examinations addressing specific diagnostic findings qualify under Medicare's existing diagnostic ultrasound coverage framework. Together with the October 1 implementation of our dedicated CPT Billing Code, this decision removes the significant reimbursement uncertainty and establishes a clear Medicare Hospital Outpatient Payment Pathway for Medically Necessary Diagnostic QT Scan Examinations. This is a very meaningful commercial milestone for QT imaging. Hospitals now have both a dedicated billing code and an established Medicare payment classification, threatening the business case for adopting our best imaging technology. Our focus is now on translating this progress into scanner installations and clinical adoption. We have developed a comprehensive coding and billing guide to support hospitals and imaging providers while continuing our engagement with Medicare and commercial payers and expanding the clinic and economic evidence needed for broader coverage. Medicare payment applies to medically necessary physician-ordered diagnostic examinations rather than routine screening. We will continue pursuing additional reimbursement opportunities related to our SAS platforms and AI software improvements. An essential part of our commercial execution is ensuring that imaging centers and hospitals have access to breast radiologists properly trained to interpret the QT scans. We have initiated a structured training program with two established radiology groups under the leadership of Dr. Emeria Mashita. These relationships will expand our clinical reading capacity and support the adoption of breast acoustic CT imaging modality across our growing installed base. Approximately 13,000 women have now been imaged using QT imaging breast acoustic CT technology, making a significant milestone in clinical adoption and reinforcing the growing real-world foundation for advancing quantitative breast imaging. Equally important, our multi-site repeatability reproducibility research demonstrated less than 1% variability in the speed of sound measurements under the conditions studied. This finding supports the operator-independent nature of our automated imaging modality, a significant advantage over conventional handheld ultrasound where image acquisition and measurements are highly dependent on operator technique and experience. Our PAIR strategy builds on the newly established Medicare reimbursement pathway for medically necessary diagnostic QT scan examination and focuses on the following clinical applications. One, diagnostic evaluation of women with dense breasts will require additional imaging following mammography. Diagnostic Evaluation of High Risk Women, particularly those who face barriers to breast MRI. Two, quantitative monitoring of response to neoadjuvant cancer therapy. And three, beyond this obligation, we see a significant opportunity to improve participation in the breast cancer screening. More than 30% of eligible women are not up to date with recommended screening. Our radiation-free, co-pressure-free technology has the potential to help bring this human back into the standard of care, although routine screening is not currently covered under Medicare. We will work diligently to generate the clinical evidence to pursue the necessary regulatory approvals and expand reimbursement pathway to make CT scan accessible to more women, particularly those who face barriers to conventional breast imaging. We're aligning our clinical research programs with these priorities, working with our clinical partners to demonstrate QT scans' incremental diagnostic value, potential to reduce unnecessary biopsies, and ability to provide quantitative biomarkers for treatment monitoring. Our objective is to generate the clinical and economic evidence needed to expand payer coverage, threaten physician adoption, and accelerate broader patient access. Third, technology and operational scale. We're building an integrated breast imaging platform, not simply a manufacturing scanner. Our breast acoustic CT technology provides radiation-free, compression-free 3D imaging and quantitative information derived from the acoustic properties of breast tissue. The QTI or LEA viewers support clinical interpretation, while QTI Precision Pathway is our cloud platform for image processing and quantitative analysis. We continue to advance our reconstruction software, improve reflection imaging quality, and streamline radiologist workflows. These investments are designed to strengthen clinical performance and support the scalability of our technology. We strengthened our scientific leadership in July with the appointment of Dr. Julia Albright as Chief Science Officer. Our role is to connect our research, product development, and clinical evidence priorities. We also completed the relocation of our headquarters and manufacturing operations to a new, approximately 22,000 square foot facility in Petaluma, California, under the leadership of our Chief Operating Officer, Steve Choate. This expansion more than doubles our available space and has approximately doubled our scanner manufacturing capacity. while significantly reducing our lease cost per square foot. The new facility allows us to streamline production workflows, improve operational efficiency, and strengthen quality control as manufacturing volumes increase. Importantly, this investment positions QT Imaging to support growing demand in the US and the international markets as we scale our commercial operations in 2027 and beyond. Execution at scale depends on quality. In July, we completed our first routine FDA inspection with zero form FDA 483 observations. This is an important result for our team and the assistance we have put in place. Fourth, international expansion and financial discipline. In July, we have received regulatory registration from Israel Ministry of Health, enabling commercialization in the market. We are working toward the scan replacement and clinical collaboration with Rambam Healthcare Campus, focused on women with hereditary breast cancer risk. Our international expansion reached a major milestone with our first commercial order in the Gulf Cooperation Council region, GCC, secured with American Hospital Dubai through our distribution partner, Alnagi Medical. American Hospital Dubai was the first healthcare institution in the Middle East to join the Mayo Clinic Care Network and operates a multidisciplinary breast institute integrating advanced imaging, breast surgery, oncology, pathology, and high-risk patient care. Beyond this first commercial order, we intend to work closely with American Hospital Dubai and Alnage Medical on joint marketing initiatives, physician education and clinical research, evaluating the performance, The clinical need in the UAE is significant. A 2023 study found that only 23% of surveyed women had undergone mammography, while a separate research report, a median breast cancer diagnosis age of 48, while 50% presenting with locally advanced or metastatic disease. Women die of breast cancer in UAE 12 years earlier than in the United States. We also receive regulatory approval for our Breast Acoustic CT scanner in Bahrain and Qatar, further expanding our authorized market presence in the Gulf region. Together with our first commercial order from American Hospital Dubai, this milestone strengthens our foundation for commercial expansion across the GCC. The Middle East conflict and disruption affecting regional logistics has delayed anticipated shipments to our customers and distribution partners in Saudi Arabia and the UAE. We are maintaining and further developing those relationships, but we cannot responsibly commit to a shipment date while conditions remain uncertain. Beyond these commercial and operational milestones, October was also an important opportunity to reinforce why we're building this company. On October 2nd, we had the honor of ringing the Nasdaq closing bell to mark Breast Cancer Awareness Month, just days after World Dance Breast Day. I emphasize the principle at the heart of QT imaging. For decades, women have been asked to adapt to breast imaging technology. We believe technology should adapt to women. Patient comfort matters because adherence to screening matters. and women with dense breasts deserve better imaging options. Our vision is to a future of breast imaging that is multi-modal, quantitative and personalized. The NAVTECH ceremony celebrated how far we've come, but our responsibility now is to bring this technology to more physicians, more communities and more women around the world. We have substantially grown our revenues, strengthened our commercial organization, substantially advance our reimbursement strategy and expand our manufacturing capabilities. We are building the infrastructure to bring QT breast acoustics CT imaging technology to more physicians and more women while maintaining our focus on commercial execution, clinical adoption, and financial discipline. With that, I will turn the call over to Jay to review our financial results.

Jay? Thank you, Raluca, and good afternoon, everyone. Revenue for the third quarter of 2026 was $7.3 million, up 75% from $4.2 million in the third quarter of 2025. The increase was primarily attributable to sales of 15 breast acoustic CT scanners in the 2026 quarter, compared with nine scanners in the prior year period. For the first nine months, Revenue was $21.3 million compared with $10.7 million a year ago. Gross profit for the quarter was $3 million compared with $1.8 million a year ago. Gross margin was 41.3% compared with 41.2% in the second quarter of 2026. Total operating expenses for the quarter were $5.5 million compared with $3.5 million in the third quarter of last year and $4.9 million in the second quarter of 2026. As we discussed on our last call, we expected operating expenses to increase as we added commercial personnel and advanced clinical work. Third quarter research and development expense was $1.7 million compared with $0.9 million a year ago. Selling, general, and administrative expense was $3.8 million compared with $2.5 million in the prior year quarter. Operating loss for the third quarter was $2.4 million compared with $1.7 million in the year-ago period. Net loss was approximately $297,000, or a few cents per share, compared with a net loss of $4.6 million, or 47 cents per share, The smaller reported net loss reflects, in substantial part, changes in the fair values of financial liabilities. In particular, the quarter included a $2.4 million non-cash gain related to the earn-out liability, compared with a $2.2 million expense in the prior year quarter. Net cash used in operating activities during the third quarter of 2026 was $2.2 million compared with $0.9 million during the third quarter of 2025 and $4.8 million during the second quarter of 2026. For the first nine months of 2026, net cash used in operating activities totaled $10.7 million compared with $5.9 million in the prior year period. As of September 30th, we had cash, cash equivalents, and restricted cash of approximately $8.4 million compared with approximately $11 million on June 30th. Now turning to our full year 2026 outlook, we are revising our revenue expectation to approximately $34 million compared with our previous guidance of approximately $39 million. The revision reflects shipment delays to our distribution partners in Saudi Arabia and the United Arab Emirates. Arising from the conflict in the Middle East and severe disruption to the region's normal shipping routes. Our U.S. scanner shipment plan is unchanged. We remain engaged with our partners, but the timing of Middle East shipments and any associated revenue recognition remain uncertain. We believe it is appropriate to reflect those conditions in our current outlook. Please refer to our third quarter earnings release in Form 10-Q for more information about the quarter's results, liquidity, and risk factors. And now, I'll turn the call back to Raluca.

Thank you, Jay. In summary, our progress reflects meaningful advances across the business. One, commercial growth. It's a strong year-over-year revenue growth with 15 breast acoustic CT scanners sold in the third quarter and 43 during the first nine months of 2026. Two, U.S. commercialization, a spending direct sales organization and expanding pipeline of qualified opportunities and continued collaboration with NXA Imaging and Canon Medical USA to accelerate customer placement. Three, reimbursement. CMS established a separate Medicare hospital outpatient payment for diagnostic QT scan examinations effective January 1, 2027, building on the implementation of our dedicated CPT billing code in October. Four, clinical adoption. We expanded radiologist training and ongoing clinical research programs aligned with our payer strategy, focusing on supplemental breast imaging, high-risk diagnostic applications, cancer treatment response monitoring, and reabsorption of women needing breast screening in the standard of care. Five, international expansion. Our first commercial order from American Hospital Dubai, regulatory approvals in Israel, Bahrain, and Qatar. in progress towards clinical collaboration in this market. Number six, operational execution. The successful relocation to our expanded Petaluma headquarters and manufacturing facility doubled our capacity to support future growth. Seven, technology innovation. Continued advancement of our integrated breast acoustic CT platform, combining quantitative imaging, improved reconstruction software, the QTI Olea Viewer, and the QTI Precision Pathway Cloud capabilities. As we approach year end, our priorities are clear. Accelerate U.S. commercial sales, convert our growing pipeline into purchase orders and scanners installations, expand clinical adoption, and continue building the evidence to support broader reimbursement. While regional instability has delayed certain shipments to our Middle East customers and distribution partners, our United States commercial strategy remains on track. We are focused on delivering strong execution to the remainder of 2026 and positioning QT Imaging for continued growth in 2027. Thank you for your interest in QT Imaging and for your continued support. With that, we are ready to take questions. Operator?

Thank you. 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 are using a speakerphone, please pick up your handset before pressing the keys. To answer your question, please press stars and two. At this time, we'll pause for just a moment to assemble our roster. And today's first question comes from Jeffrey Cohen at Leidenberg Thalman. Please go ahead.

Hello, Raluca and Jay. Thanks for taking our questions. A couple from Aaron. So firstly, can you talk about Q4, as far as placements and expectations, I know that based on your commentary, you're anticipating 27 placements. Wondering beyond MXC where you see the balance of those placements emanating from.

Hi, Jeff. Thank you so much for being with us on the call. We do expect 25 scanners sold in 2024 with 17 in the United States and the rest of them in GCC area.

Okay, got it. And could you talk about anticipated cost of goods for Q4? I think that you probably have already assembled some scanners and would we see on a percentage basis COGS for Q4 decreasing on a percentage basis?

Yeah, COGS will... So first of all, as you know, the gross margin for United States for our scanners is 41%, and the gross margin for the scanners that are sold outside United States in the GCC area is that the price is higher, the COGS is lower. So we do expect that the overall gross margin for the Q4 to increase rather than be exactly as we have it today for United States.

Okay, got it. And then, Lesley, can you talk about the U.S. Commercial Organization as it stands now with the recent ads? How many folks and how are you characterizing by geography?

Yes. Very senior sales VPs reporting into the Chief Commercial Officer, Satrajit Misra, Two of them covering the East Coast, one covering the West Coast, and that was actually absolutely an incredible progress for us to start addressing directly the customers, Jeff, on both the coasts. Obviously, the middle of the country is split equally between the sales managers of the two regions. But we're bringing in POs ourselves, and we are obviously working collaboratively with Annexy Imaging, making sure that the sales channel is kept without noise. But very happy to have them part of the team.

Perfect. Thanks for taking our questions.

Thank you so much, Jeff. Appreciate it. Thank you.

Thank you. And our next question today comes from Matt Hewitt at Craig Hallam Capital Group. Please go ahead.

Good afternoon. Thanks for taking the questions. Maybe first up, congratulations on the CMS decision. I'm just curious, what are the next steps from a reimbursement perspective? Private payers, you know, other portions of the government. Could you walk us through that, please?

Matt, thank you so much for joining. Very much appreciated. Yes, big news from CMS. It was great to see the reimbursement and Muse for QTscan. It's the first time in the history of this company and it's extraordinary news for us. The next will be the following. We will make sure that everybody is up to speed with the content of our billing and coding guide to make sure that each one of our clinics is aware of the fact that the clinics can get the reimbursement from CMS. We have already started discussions with the payers to make sure that as we get in 2027, we expand that reimbursement to other payers. A lot ahead of us, but Medicare payment for this technology is an incredible step. Hospitals can will be addressed now with QT imaging technology, imaging modality directly as much as all the other imaging modalities.

Got it. That's helpful. And then regarding the Middle East, obviously unfortunate situation, but I'm curious, once the shipping lanes do reopen, will there be a catch-up period? Meaning if you were supposed to ship five this quarter, and five next quarter. Would you ship 10 as soon as things open or will you just get back to that kind of that expected number?

Matt, our plan is to ship the scanners that are lagging behind as soon as we can actually do that. We have very good relationships in both Saudi Arabia and UAE, obviously through the distributor but directly with the customers too. The moment that we see the shipments happening, we will start addressing all those customers that are waiting for our scanners.

Got it. And then maybe one final one. Regarding the U.S. internal or direct sales team, as you look at fiscal 27, I'm sure you're just starting that planning now, but as you look at fiscal 27, is it your expectation that you will be adding resources to that team, or do you want to kind of get these three up and running first? Thank you.

So, Matt, good question. So, first of all, the three senior sales managers are doing a great job, and they'll be covering both Q1 and Q2 of next year, and they already have a very strong backlog for us to start sailing into 2027. Obviously, the discussions with NXT Imaging and Canon Medical USA progressed very well. and we're going to get the news to the market the moment that we have final terms for our agreement. Are we going to increase our sales team? I strongly believe that we have to see the first two quarters in 2027, how we bring in the orders and how the backlog looks like to decide if we are going to increase the number of sales managers in the United States.

Got it. Thank you.

Appreciate it. Thank you, Matt.

Thank you. And our next question today comes from Pat McCann at D. Burrell Capital. Please go ahead.

Hi. Thanks for taking my question. It's just a couple here. First, I wanted to touch on the cash balance of, I believe, around $8 or so million at the end of the quarter and the receivables that you collected in October. What would be your updated kind of expectations around your cash runway and How has that changed at all in terms of your potential need for capital and kind of how you view your ability to kind of continuing to progress with the cash you have on hand right now?

Thank you so much for being with us. Very much appreciated. Wonderful to have you all with us. We pushed out some of the scanners' revenue, not necessarily depleting our cash. We're very careful about our cash, and we do make sure that we stay within the limits of our balance sheet, without doubt. Thank you very much. Thank you.

Thank you for joining us. Maybe the Middle East and those channels would be in your internal projections. I'm just kind of trying to get a sense of what the impact could be if this situation persists for a longer term.

Yeah, very good question. First of all, remember this. The CMS reimbursement opens up the business for QT imaging to the hospitals. For us, there's a segment that we didn't even project in in 2027. So it's a segment that we really believe will open up doors for United States business. We do have scanners planned for GCC, obviously. It's a very important segment for us. But we do believe that the business in the United States will take us to 25% growth year over year in revenue.

Excellent. Thank you so much. That's all I had. Appreciate it.

I appreciate it. Thank you so much for the great questions.

Thank you. And our next question today comes from Ben Hanor at Lake Street Capital Markets. Please go ahead.

Good afternoon. Thanks for taking the questions, and congrats on the CMS outcome here recently.

Hi, Ben. Thank you so much.

Yeah, no problem. First off, for me, just on, you know, kind of the medically necessary diagnostic language, I mean, is that something that applies to, you know, kind of all women with dense breasts, those under 40 with a family history? What kind of group is that, does that kind of total up to?

Yeah, so all women that come to, sorry, Ben, can you hear me? So it's diagnostic imaging. It's supplemental imaging, a band for everybody that needs it. It's not screening, and it's like we always discussed. We do not have clearance for screening, like mammography, for example, has. But we do have clearance for all women that need this imaging modality for diagnostics, which is obviously a lot. and a large category of women. As we know, Ben, 50% of women in the United States have dense breasts. The cancers are hiding in dense breasts. The cancers are hiding in dense breasts that are being imaged by mammography. So this is where we shine.

Yeah, that's helpful. And then it looks like the potential hospital market with the premier agreement not too long ago You know, that seems to obviously fit well with the CMS development. Have the sales folks that you have on board now, have they already started to have conversations with this channel? And if so, how are they going so far?

Absolutely. Our direct sales force, NXC Imaging, our distributor partner in the United States, everybody is extremely excited about the reimbursement news from CMS, definitely the relationship with Premier. We have a big year ahead of us, so we'll put our head down and execute as we've done until now.

Any plans for other international markets entering next year?

Ben, first of all, we have to properly develop Saudi Arabia, UAE, Israel, Bahrain, Qatar, and towards the middle of next year we are going to get hopefully the reimbursement, I'm sorry, the regulatory approval in Europe. It is a lot to do within a year because obviously our main focus is United States and as a second priority growing the business in GCC countries and after that Europe is next. But yes, Ben, that's our focus.

Okay, great. Well, thank you so much for the color and congrats on the progress.

Thank you so much, Ben. Thank you so much for being with us.

Thank you. And that concludes our question and answer session. I'd like to turn the conference back over to Dr. Raluca Dinu for closing remarks.

Thank you so much. I want to thank everyone for joining us today and for your continued interest in QT imaging. We remain focused on discipline execution as we finish the year and prepare for 2027. We look forward to discussing our progress during our next conference call. Until then, have a nice evening. Thank you so much.