QT Imaging Holdings, Inc. Q1 FY2026 earnings call

• Commercial Execution & Financing Updates: Shipped 13 QT Breast Acoustic CT systems in line with commercial distribution commitments, expanding the installed base domestically and internationally. Subsequent to quarter-end, the maturity date of the $10.1 million Senior Secure Term Loan with Linn-Rock Lake was extended 2 years from March 31, 2027 to March 31, 2029 (interest rate increased from 10% to 12% annually), providing extended financial flexibility for growth initiatives. Management emphasized continued disciplined execution of the company's commercial and technological roadmap.
• Regulatory, Reimbursement & Clinical Milestones: Secured AMA approval for a new Category 3 CPT code for the company's technology, effective January 1, 2027, a key step toward standardization, utilization tracking, and future reimbursement pathways. Received FDA 510(k) clearance for a scanner and platform enhancement that improves visualization and coverage of posterior breast tissue, a region historically difficult to evaluate with traditional imaging. Secured regulatory classification and clearance for both the scanner and QTI SaaS cloud platform in the United Arab Emirates, under the company's distribution agreement with Al-Naghi Medical Company. Published encouraging early results from a Mayo Clinic prospective feasibility study that found high absolute agreement between QT Imaging and MRI for supplemental breast screening in high-risk women, supporting comparable effectiveness for identifying positive findings. Expanded the clinical advisory team with two experienced breast care leaders to support clinical strategy, reader training, workflow integration, and real-world evidence collection.
• Software & Platform Innovation: Launched the QT Imaging Golea Viewer, a multi-modality platform that supports cross-modality imaging review, correlation of findings, longitudinal patient evaluation, and quantitative analysis. Released software version 4.5.0, a next-generation image reconstruction update that delivers 40-50% improved spatial resolution in reflection imaging while maintaining efficient processing times, enhancing overall image quality and clinical utility.
• Strategic Positioning: The company's technology is positioned as a radiation-free, compression-free 3D quantitative breast imaging platform addressing the unmet need for improved screening and diagnosis for women with dense breast tissue. Management confirmed the strategic roadmap to transition from a primarily hardware-focused business to a recurring revenue model including software, cloud services, and AI-enabled offerings as the installed base and data assets grow.

QT Imaging Holdings operates a single core product segment focused on breast imaging hardware and related cloud software services. For Q1 2026, total company revenue was $6.5 million, representing a 133% year-over-year increase from Q1 2025. All revenue was derived from product sales of the QT Breast Acoustic CT scanner and early cloud platform services; 13 scanners were shipped in Q1 2026, up from 6 units in the prior year quarter. Cost of revenue was $3.9 million in Q1 2026 (vs $986,000 in Q1 2025), resulting in a 41% gross margin for the quarter, down from 65% in Q1 2025 (the 2025 margin was elevated due to the sale of two lower-cost-basis scanners). Total operating expenses for Q1 2026 were $5 million, up from $2.9 million in Q1 2025, driven by higher employee compensation and professional service costs. Net loss for Q1 2026 was $3.4 million, a substantial reduction from the $11.1 million net loss in Q1 2025. Reported EBITDA was negative $2.5 million (negative $1.5 million adjusted EBITDA, excluding non-cash expenses like stock-based compensation and warrant/earn-out fair value changes), compared to negative $10.4 million reported EBITDA and negative $903,000 adjusted EBITDA in the prior year quarter. As of March 31, 2026, the company held $7 million in total cash, restricted cash and cash equivalents.

• Management affirmed full-year 2026 revenue guidance of approximately $39 million, which represents more than double the company's 2025 total revenue.
• The 2026 guidance is based on expected scanner shipments under contracted distributor minimum order quantities, plus early monetization of cloud-based services as the platform is rolled out to clinical and research customers.
• Contracted distribution commitments to date include: 60 2026 scanners from NXC Imaging; 20 2026, 32 2027, and 40 2028 scanners from Gulf Medical (total contract value exceeding $51 million); and 7 2026, 16 2027, and 20 2028 scanners from Alnage Medical (total contract value approximately $24 million).

• The company noted that all forward-looking statements involve inherent known and unknown risks, uncertainties, and other factors that could cause actual results to differ materially from projected outcomes, related to product commercialization, manufacturing scaling, regulatory approval timelines, clinical adoption, reimbursement expansion, and platform development. Detailed risk disclosures are included in the company's SEC filings.
• The company does not currently have Saudi Arabia FDA (SFDA) approval for commercial sales, and final approval timing remains uncertain, even with only a small number of outstanding regulatory questions remaining. The timing of commercial shipments to the Gulf region is also dependent on regional geopolitical stability related to ongoing conflict.
• Commercial expansion into additional international markets is dependent on successful completion of regulatory reviews across multiple jurisdictions, with timelines that are outside the company's full control.
• The company is currently operating at a net loss, with negative cash flow from operating activities, and depends on external financing to support ongoing growth and operations.

Q: What is the current regulatory status for Gulf Medical's territory, what is the timeline for Saudi FDA approval, and what are the key terms of the expanded distribution agreement, including any software/SaaS components? / A: The company has already received full UAE regulatory approval, but Saudi FDA (SFDA) approval is still pending. Only 1-2 outstanding regulatory questions remain, and management expects SFDA approval within 1 month, no later than the end of 2026. Shipments to the UAE will begin once regional geopolitical conflict eases, and shipments to Saudi Arabia will launch immediately after SFDA approval is secured.

Q: Can you provide an update on the amended Canon/NXC Imaging distribution agreement, including timeline and plans beyond 2026? / A: The 2026 contracted 60-scanner commitment from NXC Imaging remains in place. Discussions about additional distribution volume and extended terms beyond 2026 are ongoing with NXC Imaging and Canon USA, and the company will provide a formal update once these discussions are finalized on a future earnings call.

Q: Does the new 4.5.0 software update with improved image quality specifically benefit detection of challenging findings like calcifications? / A: The update delivers a 40-50% resolution improvement across all three axes for reflection imaging, which improves visualization for all breast findings. Critically, calcifications are detected via reflection imaging (not transmission imaging) in QT's system, so the resolution improvement directly enhances detection of this key cancer-related finding.

Q: Can you share an update on longitudinal imaging and biopharma therapy monitoring applications? / A: A manuscript with precision therapy response monitoring results from Sunnybrook Cancer Center is ready for submission. The study demonstrates that QT Imaging's volume-based measurement of tumor changes is far more precise than standard linear dimension measurement, which has higher error. A second similar study at a large Boston institution is planned, and the company continues to see strong interest in this application area.

Q: Are there ongoing discussions for new distribution agreements in additional international markets this year or next? / A: The company is pursuing regulatory approval for four additional Gulf Cooperation Council countries, which will take 1-2 quarters. Approval for Israel's MAR regulatory pathway is expected by August or September 2026. CE marking for the European Union is on track to be completed in Q2 2027.