QTI

Commercial Progress & Expansion

• Shipped 15 breast acoustic CT scanners in Q2 2026 in line with U.S. shipment plans, marking continued scaling of commercial adoption, with over 12,000 women imaged on the platform to date
• Expanded U.S. commercial infrastructure by adding two regional Vice Presidents of Sales, complementing the existing exclusive distribution partnership with NXT Imaging (a Canon Medical Systems USA subsidiary) to build a hybrid scalable commercial model combining direct engagement and established distribution
• Expanded international commercial reach via regional partner agreements: distribution partnerships with Gulf Medical (Saudi Arabia) and Al Nadi Medical (United Arab Emirates), and a sales agent partnership with Re:Invent (Pakistan)
• Secured new regulatory clearances: Saudi Food and Drug Authority (SFDA) clearance for the breast acoustic CT scanner, and AMAR authorization from Israel's Ministry of Health, expanding commercial access across the Middle East

Clinical & Regulatory Milestones

• Received two FDA clearances in H1 2026 for platform enhancements, including improved posterior breast imaging hardware and volumetric measurement software functionality
• Gained American Medical Association approval for a dedicated Category III CPT reimbursement code, effective January 1, 2027, which creates a standardized framework for utilization tracking and future coverage decision development
• Published multi-site study results demonstrating <1% variability in speed of sound measurements across scanners, confirming the platform's reproducibility for quantitative longitudinal imaging
• Multiple ongoing and planned clinical studies: a 100+ patient follow-up study at Mayo Clinic (building on positive pilot feasibility results comparing QT scan to MRI), a prospective study with Dr. Barry Roseman evaluating diagnostic performance, a 100-patient study at Sunnybrook, and an NIH-funded study evaluating treatment response monitoring for neoadjuvant chemotherapy patients
• The first Israeli scanner will be placed at Rambam Healthcare Campus for a clinical study in high-risk hereditary breast cancer patients
• Completed the first routine FDA inspection since company founding with zero Form FDA 483 observations, reflecting strong quality management systems

Product & Platform Innovation

• Launched software version 4.5.0, improving spatial resolution of reflection imaging while maintaining efficient clinical workflow processing times
• Collaborating with Olea Medical to develop an integrated advanced viewer for multi-modality correlation and longitudinal evaluation, and with Intellirad to build secure cloud and PACS infrastructure for enterprise deployment
• Advancing the QTI cloud-based precision pathway platform to support secure image management, clinical collaboration, quantitative analysis, and future AI-enabled applications

Operational & Financial Updates

• Strengthened the balance sheet via a $10 million underwritten public offering, and extended the maturity of its $10.1 million senior secured term loan with Lynrock Lake by two years to March 2029, providing increased financial flexibility for ongoing initiatives
• Entered an agreement to relocate headquarters and manufacturing to a new 22,000 square-foot facility in Petaluma, California, which will more than double operational space while holding total lease costs flat via a 55% reduction in per-square-foot lease cost, expanding manufacturing capacity to support future growth
• Appointed Dr. Julia Albright as Chief Science Officer, bringing 30+ years of medical imaging, AI, and healthcare technology leadership to align scientific and innovation strategy

Strategic Priorities for H2 2026

1. Accelerate commercial adoption and installed base growth
2. Strengthen clinical and scientific evidence for the platform
3. Expand global market access
4. Advance the quantitative imaging platform capabilities
5. Scale the business with disciplined operational efficiency

• Management affirmed full-year 2026 revenue guidance of approximately $39 million, which represents more than doubling 2025 total revenue of $18.9 million, based on expected scanner shipments under distributor minimum order quantities and contributions from direct sales
• For back-half 2026 quarterly operating expenses, management expects a slight increase from the Q2 2026 level of $4.9 million, driven by expanded sales team compensation and shifted clinical study expenses from H1 to H2 2026
• U.S. shipment guidance for H2 2026 calls for 15 scanners in Q3 2026 and 17 scanners in Q4 2026, with a gradual ramp in placements quarter-over-quarter

QT Imaging operates as a single-segment business focused on breast acoustic CT scanners and related software/cloud services. In Q2 2026, the company generated total revenue of $7.4 million, a 103% increase year-over-year from $3.7 million in Q2 2025. Revenue growth was driven by higher scanner shipments: 15 scanners shipped in Q2 2026 compared to 8 in the prior-year quarter. Gross margin for Q2 2026 was 41%, in line with management projections for U.S. sales, down from 50% in Q2 2025 due to a change in the weighted average cost of sold inventory. Total operating expenses were $4.9 million in Q2 2026, up from $2.9 million in Q2 2025, reflecting higher employee compensation, professional service, and marketing costs. Operating loss came in at $1.9 million for Q2 2026, compared to a $1 million operating loss in Q2 2025. Net loss for Q2 2026 was $11.1 million, which included an $8.3 million non-cash loss on debt modification and extinguishment, versus a $4 million net loss in Q2 2025. For the first half of 2026, total revenue reached $14 million, up from $6.5 million in the first half of 2025, on 28 scanner shipments shipped, up from 14 in the prior year first half.

• Forward-looking statements related to product commercialization, manufacturing scaling, platform development, new product launches, and revenue growth are subject to known and unknown risks and uncertainties that could cause actual results to differ materially from projections, as detailed in the company's SEC filings
• Geopolitical conflict in parts of the Gulf Region has negatively impacted commercial activity in the region, though management is seeing early signs of renewed customer engagement
• Scanner implementation and customer installation progress is slower than management desires, requiring additional direct support efforts to accelerate deployment
• Commercial expansion and product development require continued capital investment, and reliance on external financing introduces uncertainty around the company's ability to fund long-term growth initiatives

Q: What is the status of commercial activity in Pakistan? / A: QT Imaging has a sales agent agreement with Pakistan-based woman-led company Re:Invent. A small number of systems are planned for deployment in Pakistan over the next few months, and no additional local regulatory clearance is required beyond existing FDA clearance, which is accepted for the Pakistan market.

Q: How is the hybrid direct and distribution U.S. commercial model progressing, and what is the shipment cadence for H2 2026? / A: The company is on track to ship 15 scanners in Q3 and 17 scanners in Q4 2026, with a gradual ramp in placements quarter-over-quarter. The newly expanded direct sales team focuses on solution-focused sales to imaging centers and enterprise hospital segments, while continuing to leverage the NXT Imaging distribution partnership. Direct sales will take on increasing responsibility for the U.S. market starting in 2027, with continued support from NXT.

Q: What are the goals of the new 100+ patient Mayo Clinic study, and how does it relate to reimbursement strategy? / A: The new follow-up study aims to confirm that QT Imaging identifies all suspicious lesions found on MRI, and tests whether the modality can reduce unnecessary biopsies by downgrading BI-RADS 4 findings to lower-risk BI-RADS 3 categories. All data from this and other clinical work will be collected under the newly approved Category III CPT code, effective 2027, to build the evidence base for future reimbursement coverage decisions; no additional codes are planned at this time.

Q: What is the commercial and clinical plan for the newly approved Israeli market? / A: The first scanner will be placed at Rambam Healthcare Campus for a clinical study focused on longitudinal imaging of high-risk hereditary breast cancer patients, and to understand how the technology fits into Israel's standard of care. Management is currently evaluating potential distribution partners for the Israeli market, and will provide an update on a future call. The company is also pursuing regulatory approval in additional Gulf markets Qatar and Bahrain, with CE Mark targeting for 2027.