Conference Transcript - QTI 2026-05-13

Operator

Good day, and welcome to the QT Imaging Holdings First Quarter 2026 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, then 1 on a touch-tone phone. To withdraw your question, please press star, then two. Please note this event is being recorded. I would now like to turn the conference over to Bruce Voss. Please go ahead.

Bruce Voss, Head of Investor Relations

This is Bruce Voss with Alliance Advisors IR. Thank you for participating in today's call. Joining me from QT Imaging Holdings are Dr. Raluca Dinu, 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 actual results, performance, or achievements to be materially different from those implied by such statements. All forward-looking statements are based on QT Imaging's current beliefs, as well as assumptions made by and information currently available to QT Imaging and relate to, among other things, QT Imaging's breast acoustic CT scanner, including its product commercialization and manufacturing, the evolution of QT Imaging into a scalable imaging platform, the QTI cloud platform and 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 the live broadcast, May 13, 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? Thank you, Bruce, and good afternoon, everyone.

Dr. Raluca Dinu, CEO

Thank you for spending the time with us and for your interest in QT imaging. The first quarter of 2026 was a highly productive period for QT imaging as it continues to execute across commercialization, clinical validation, reimbursement, regulatory expansion, and software innovation. We believe that the progress achieved during the quarter further strengthens the foundation for the long-term adoption of our technology and supports our strategy of building a leading quantitative breast imaging platform. During the quarter, we shipped 13 QT breast acoustic STT systems, which was in line with our commercial distribution commitments. These shipments reflect continued operational execution and growing commercial activity as we expand our installed base, both domestically and internationally. We're also pleased to announce that subsequent to the close of the quarter, the maturity date of our senior secure term loan with Lynn Rock Lake was extended by two years, from March 31, 2027 to March 31, 2029. We would like to thank Lynn Rock Lake for their continued support and confidence in QT imaging. This extension provides the company with additional financial flexibility as we continue executing on our commercial, clinical, and strategic growth initiatives. On the reimbursement front, we achieved an important milestone with the approval by the American Medical Association of a new Category 3 CPT code for our technology, effective January 1, 2027. We believe this is a meaningful step toward broader clinical adoption, standardized reporting, utilization tracking, and future reimbursement pathways for our technology. We also receive FDA 510 clearance for enhancement to our breast acoustic CT scanner and platform designed to improve visualization and imaging coverage of posterior breast tissue. This region has historically been challenging to evaluate with traditional breast imaging technologies, and we believe the updated configuration further improves the clinical utility and overall performance of our system. On the international regulatory front, we secured official classification and clearance in the United Arab Emirates for both our QT breast acoustic CT scanner and the QTI SaaS cloud platform under our distribution agreement with Al-Nagi Medical Company. We also continue to advance our software ecosystem and imaging capabilities. During the quarter, we launched the Qt Imaging OLEA Viewer, an innovative multi-modality imaging platform designed to support efficient review and correlation of imaging findings across modalities, while enabling longitudinal patient evaluation and quantitative analysis. In parallel, we released software version 4.5.0, a next-generation image reconstruction update that improves spatial resolution in reflection imaging and enhances image quality while maintaining efficient processing time. We believe continuous software innovation will remain a key differentiator and advantage for Qt imaging as we expand our install base and advance toward a more scalable imaging and data platform. Importantly, our commercial efforts continue to be supported by growing clinical evidence generated at leading institutions. For example, at the Mayo Clinic, a prospective feasibility study evaluating QT scan as a supplemental screening tool compared to the MRI in high-risk women provided encouraging early validation of the technology. This study demonstrated absolute agreement between QT imaging and MRI, suggesting comparable effectiveness of QT imaging and MRI in identifying positive findings. We also continue to strengthen our clinical and medical advisory team. During the quarter, we welcomed Dr. Maryam Ashita, a senior clinical advisor, to support our clinical strategy, reader training activities, and development of structured interpretation pathways for QT scan. More recently, we welcomed Dr. Barry Rosman, a senior medical advisor. Dr. Rosman is a breast surgical oncologist with more than 25 years of experience treating breast cancer and breast disease. He currently operates Advanced Breast Care Surgical Oncology of North Georgia, which is a comprehensive breast imaging and diagnostic center. His engagement with QT imaging includes implementation of QT scan within his busy clinical practice to support physician training, workflow integration, patient access, and the collection of real-world clinical and operational experience with the technology. Given his extensive experience treating women with dense breast tissue, Dr. Rosman understands firsthand the limitation of existing imaging modalities, which can miss cancers in dense breast, and the need for additional technologies capable of providing more quantitative and clinically meaningful information. We believe Qt imaging technology is uniquely positioned as a radiation free, compression free, true 3D breast imaging platform capable of delivering quantitative information that may improve clinical decision-making, particularly for women with dense stress. More broadly, we believe QT imaging sits at the intersection of advanced imaging, quantitative diagnostic, and AI-enabled healthcare infrastructure. Overall, we remain focused on discipline execution as we continue expanding commercialization efforts, advancing our technology platform, and building long-term value for patients, providers, and shareholders. Now, I'll turn the call over to our CFO, Jay Jennings,

Jay Jennings, CFO

to review our financial results. Jay? Thank you, Raluca, and good afternoon, everybody. Revenue for the first quarter of 2026 was $6.5 million, up 133% from the prior year quarter. The increase was primarily attributable to the shipment of 13 breast acoustic CT scanners during the quarter, up from six scanners in Q1 2025. Cost of revenue for Q1 2026 was $3.9 million compared with $986,000 for Q1 2025, resulting in a gross margin for the 2026 quarter of 41% compared with 65% for the 2025 quarter. The higher gross margin in the 2025 quarter was primarily due to the sale of two scanners with a lower cost basis. Total operating expenses for the first quarter of 2026 were $5 million versus $2.9 million a year ago. The increase was primarily attributable to higher employee compensation and professional and outside service costs. Net loss for the first quarter of 2026 was $3.4 million, which is a substantial reduction from a net loss of $11.1 million for the first quarter of 2025. EBITDA for Q1-2026 was negative $2.5 million compared with negative $10.4 million for Q1-2025. Excluding stock-based compensation and other non-cash expenses, such as the change in fair value of the warrant and earn-out liabilities, adjusted EBITDA for Q1 2026 was negative $1.5 million compared with negative $903,000 for Q1 2025. Net cash used in operating activities during the first quarter of 2026 was $3.7 million compared with $3.5 million used during the first quarter of 2025. As of March 31st, 2026, the company had cash, restricted cash, and cash equivalents of $7 million. Please see our Form 10-Q filed earlier today for further details regarding our first quarter financial results. Subsequent to the close of the quarter, we amended our credit agreement with Lynn Rock Lake, extending the maturity date of the $10.1 million Senior Secured Term Loan to March 31, 2029, and increasing the interest rate from 10% per annum to 12% per annum. now 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 the early monetization of cloud-based services, as we bring our platform online across clinical and research customers. Under our distribution agreements, in addition to the 60 scanners contracted by NXC Imaging for 2026, Gulf Medical is contracted for 20 scanners in 2026, 32 scanners for 2027, and 40 scanners for 2028 for a total exceeding $51 million. Alnagi Medical is contracted for seven scanners in 2026, 16 scanners in 2027, and 20 scanners in 2028 for a total of approximately $24 million. And now I'll turn the call back to Raluca.

Dr. Raluca Dinu, CEO

Thanks, Jay. So in summary, QT Imaging is building a leading platform in breast imaging and quantitative imaging-based precision diagnostics. We have done the following. One, we have a differentiated technology addressing a large unmet need in dense breast imaging with greenfield opportunities in adding biomarkers and precision breast technology. Two, we have a strong clinical regulatory and reimbursement momentum including our new category 3 CPT code. Three, we have strategic manufacturing distribution and software partners that support global scale in the SaaS-enabled business model, and four, we have a clear roadmap from hardware to recurring software and AI revenue as we expand our installed base and data assets. We are excited by the progress we've made and we are confident in the path ahead. Thank you so much for your interest in our company and for your support. And with that, we are now ready to take questions. Operator?

Operator

We will now begin the question and answer session. To ask a question, you may press star then one on your touchtone phone if you are using a speaker phone please pick up your handset before pressing the keys if at any time your question has been addressed and you would like to withdraw your question please press star then two at this time we will pause momentarily to assemble our roster the first question today comes from jeffrey cohen with Ladinburg-Thalman. Please go ahead.

Jeffrey Cohen, Analyst — Ladenburg-Thalman

Hey, good afternoon, Raluke and Jay. Thanks for taking our questions, and congrats on all the accomplishments in the quarter. So, firstly, can you touch upon Gulf Medical? What's the regulatory status in Saudi that's approved? And then could you talk about the updated and amended agreement that expands the units and the timeline to maybe give us a sense of how those financials work as far as units and or the additional software AI or SAS model that may be included.

Dr. Raluca Dinu, CEO

Hi, Jeff. Great to hear you, and thank you so much for joining us. So going back to the beginning of your question, so we got the UAE regulatory approval, MOHAP in UAE, and we are not there yet with SFDA. So, Saudi Arabia FDA approval is still to be received. Jeff, I can tell you, we've gone back and forth three, four times with them how we are at like one or two questions left. So, we do hope within the next month or so we're going to get our FDA approval. So, we – I'm sorry, please.

Jeffrey Cohen, Analyst — Ladenburg-Thalman

No, go ahead.

Dr. Raluca Dinu, CEO

So, regarding for the Gulf in Saudi Arabia and UAE, we are discussing back and forth with our distribution partners there. As soon as the war gives us a little bit of a break, we'll start shipping in UAE. And as soon as we get our SFDA, Saudi Arabia, FDA approval, we'll start shipping in Saudi Arabia. Okay.

Jeffrey Cohen, Analyst — Ladenburg-Thalman

Would you anticipate Saudi approval this calendar year?

Dr. Raluca Dinu, CEO

Saudi Arabia FDA, Jeff, it should be within a month or so. That's hopefully no later than that.

Jeffrey Cohen, Analyst — Ladenburg-Thalman

Okay. Got it. And then I wanted to jump over to your canon agreement. So could you talk about, it was mentioned in the press release, you called it an amended distribution agreement. and maybe talk about that and tell us if there's been any updates recently as far as timeline and cadence and perhaps beyond this year.

Dr. Raluca Dinu, CEO

We've pushed out that of the company from March 31, 2027 to March 31, 2029. The team at Lynn Rogue Lake is very kind and we've discussed this back and forth and they do have the trust in the company and obviously in the strategy of us together. But in terms of NXC imaging, the contract is for 2026. are discussing with nxc imaging and canon usa further business beyond 2026 um and we'll uh we'll update in uh in the next calls as we have more data on that we've met in seattle at the sbi um conference and we'll continue needing to hash out what's happening beyond 2026 but thank you so much for the question thank you thank you so much great

Operator

great to hear you, Jeff. As a reminder, if you would like to ask a question, please press star then one to join the question queue. The next question comes from Ben Hainor with Lake Street

Ben Hainor, Analyst — Lake Street Capital Markets

Capital Markets. Please go ahead. Good afternoon, Luke and Jay. Thanks for taking the questions. Hi, Ben. First off, so first off for me on the software improvements that you bumped up the imaging quality on, is there anything beyond, I mean, obviously in just improving the image quality is a good in and of itself, but are there any sort of edge cases, whether it's like calcification or things of that nature where the updated image algorithms do a much better job of helping folks identify, you know, important structures or findings?

Dr. Raluca Dinu, CEO

Ben, that's a great question. So, first of all, we have improved the resolution of our reflection images in the X, Y, and Z direction, meaning for like 40% to 50% improvement in the resolution. That is critical as we are looking into the morphological shapes of various findings in the breast. so to your point indirectly we are having better resolution with all the findings the results from the reflection in the breath but certainly uh calcification is the one um one finding critical uh for for and that they get discovered via our reflection not via our transmission so thank you so much for bringing that up um the 4.5.0 software version directly improves resolution for us to get certification.

Ben Hainor, Analyst — Lake Street Capital Markets

Okay, great. That sounds like a great update. And then on the kind of, I guess, longitudinal imaging slash biopharma front, you know, I know the applications there are potentially pretty exciting anymore to share. The investors would be interested on that front. Okay.

Dr. Raluca Dinu, CEO

Ben, we are ready to submit a manuscript for a paper with clear results that show the responders of various therapies. These are results from our Sunnybrook Cancer Center NIH program, and I think everybody will be very pleased reading the paper. It's exactly what we discussed in the past. The patients are being tracked, the volume is being measured of the findings under the certain treatment, and rather than the linear dimension that has much higher error in the measurement, the volume is clearly showing the increase or decrease with much higher precision. So, paper is going out. We have one other very large institution in Boston that's going to be working with us on a very similar study. We do seem to be getting a lot of interest in the precision therapy monitoring, as you and I discussed again and again over the last quarter. We're tracking this very important direction for us.

Ben Hainor, Analyst — Lake Street Capital Markets

Great. Looking forward to seeing that. And then lastly for me, and I apologize if you already mentioned this, but on the kind of new distribution agreements front, you know, obviously you've got a couple of Middle East distributors and then NXC Imaging. Are there other discussions that are ongoing that, you know, folks should maybe think about new countries coming on, you know, this year, next year, what have you?

Dr. Raluca Dinu, CEO

Yes, so we would like to cover fully the Gulf region, Ben, for obvious reasons. We have other four countries in the Gulf regions we're trying to cover from a regulatory perspective. It will take us a quarter or two. We have applied also for AMAR regulatory approval in Israel. It will take us probably until August or September to get to that. and we'll work through the year to get our paperwork together for CE mark, like we discussed. That's tracking as we promised in the past. We'll probably have that up and running Q2 next year. But that's where we are in terms of expansion, international expansion. A lot to do in the United States for sure, but we're tracking international expansion too.

Ben Hainor, Analyst — Lake Street Capital Markets

Okay, very helpful. That's all I have. Thank you so much.

Dr. Raluca Dinu, CEO

Oh, thank you so much, Ben. Thank you so much for joining.

Operator

This concludes our question and answer session. I would like to turn the conference back over for any closing remarks.

Dr. Raluca Dinu, CEO

Thank you so much, Betsy. Once again, I'd like to thank you for joining us today and for your interest in QT imaging. We are energized by our momentum with more to come. We look forward to discussing our progress during our next conference call in August and when we can report the second quarter results. until then have a nice afternoon and thank you so much the conference is now

Operator

concluded thank you for attending today's presentation you may now disconnect