Core Insights - Nanox Imaging Ltd. reported a net loss of $14.7 million for Q2 2025, an increase from a net loss of $13.6 million in Q2 2024, primarily due to higher gross loss and finance expenses [4][15] - The company generated revenue of $3.0 million in Q2 2025, up from $2.7 million in Q2 2024, driven by teleradiology services, imaging systems sales, and AI solutions [5][8] - Nanox is on track to meet its year-end deployment target for the Nanox.ARC system, with a growing commercial pipeline and a breakthrough in the European market [3][18] Financial Performance - The gross loss for Q2 2025 was $3.2 million, with a gross loss margin of 107%, compared to a gross loss of $2.9 million and a margin of 106% in Q2 2024 [6][8] - Non-GAAP gross loss for Q2 2025 was $0.6 million, compared to $0.2 million in Q2 2024, indicating a worsening trend in operational efficiency [16][47] - Research and development expenses remained stable at $4.8 million for both Q2 2025 and Q2 2024, while sales and marketing expenses increased to $1.2 million from $0.8 million [12][13] Business Developments - The company has expanded its customer base, including major medical imaging center chains in the U.S., and is preparing for the first system shipment to Romania [8][3] - Nanox has notified the FDA of its intent to submit the TAP2D software module for a 2D view image output, enhancing the functionality of the Nanox.ARC systems [8] - A multi-year Volume Supply Agreement was established with Fabrinet to support scalable production of Nanox.ARC X [8] Liquidity and Capital Resources - As of June 30, 2025, the company had total cash and equivalents of $62.6 million, down from $83.5 million at the end of 2024, with a negative cash flow from operations of $19.6 million during the reported period [19][20] - The total assets decreased to $184.2 million from $210.0 million at the end of 2024, reflecting a decline in cash and marketable securities [30][20] Shareholder Information - The company had approximately 63.9 million shares outstanding as of June 30, 2025, a slight increase from 63.8 million shares at the end of 2024 [21][20] - The accumulated deficit increased to $401.7 million as of June 30, 2025, compared to $373.7 million at the end of 2024 [30][20]

Business Updates - Nanox submitted a new 510k submission to the FDA to expand the intended use cases for the Nanox.ARC for general use, including chest[13] - Nanox advanced the US deployment program for the Nanox.ARC technology, with systems installed in eight states[14, 18] - Nanox.AI Receives FDA 510K Clearance for HealthCCSng V2.0, upgraded version of the cardiac solution, introduces additional 'zero calcium' categorization of coronary calcium (CAC) and generates an exact calcium score with corresponding CAC detection category output[15] - Nanox is engaged with various OEMs and governments around the world to evaluate and/or develop X-ray tubes, industrial inspection applications, security systems, dental, veterinary and other novel medical devices[21] Commercial Strategy - Nanox employs a hybrid approach combining a usage-based MSaaS model with a CapEx model to help promote adoption[19] - Under the MSaaS model, for U.S. CPT Code 76100, the reimbursement range is $88–$109, with Nanox pricing at $30 for scanning and $20 for reading, resulting in a net to operator of $28–$49 (48%-62%) and $10 (33%) respectively[19] - Outside the U.S., Nanox prices scanning at $14–$17 and reading at $20, totaling $34–$37[19] AI Solutions & Clinical Performance - Corewell Health significantly increased their ability to detect coronary calcification by using Nanox.AI's cardiac solution, identifying nearly 3,721 new patients in 2023 compared to just 268 patients having CAC reported in the previous two years[37, 39] - Early findings in the ADOPT study show that Nanox.AI software improves the detection of spine fractures, an early sign of osteoporosis, outperforming UK National Health Service national average[41, 43] - Clinical Trial 08.2024: Preliminary Results for Chest DTS, Radiographically occult lesion (seen on DTS only. Not seen on CXR): 19/26[66] Nanox.ARC X - Nanox.ARC X is a future 3D digital multi-source tomosynthesis system with a smaller footprint[86, 88]

Core Insights - Nanox Imaging Ltd reported a net loss of $13.2 million for Q1 2025, an increase from a net loss of $12.2 million in Q1 2024, primarily due to a $1.0 million increase in gross loss [3][8][13] - The company generated revenue of $2.8 million in Q1 2025, up from $2.6 million in Q1 2024, driven by teleradiology services, imaging systems sales, and AI solutions [4][8] - Nanox received FDA 510(k) clearance for its updated Nanox.ARC X system, marking a significant milestone in its mission to enhance access to medical imaging technology [2][8] Financial Performance - The gross loss for Q1 2025 was $3.0 million, with a gross loss margin of 108%, compared to a gross loss of $2.1 million and a margin of 80% in the prior year [5][8] - Non-GAAP gross loss for Q1 2025 was $0.4 million, a decline from a non-GAAP gross profit of $0.6 million in Q1 2024 [14][45] - Revenue from teleradiology services was $2.6 million in Q1 2025, up from $2.4 million in Q1 2024, with a GAAP gross profit margin of approximately 17% [6][8] Operational Highlights - The company has over 60 imaging units in various stages of implementation for commercial, demonstration, and clinical use [2] - Research and development expenses for Q1 2025 were $5.0 million, a slight decrease from $5.2 million in the prior year [10] - Sales and marketing expenses increased to $0.9 million in Q1 2025 from $0.8 million in Q1 2024 [11] Liquidity and Capital Resources - As of March 31, 2025, the company had total cash and cash equivalents of $72.9 million, down from $83.5 million at the end of 2024 [17] - The company experienced negative cash flow from operations of $10.3 million during the reported period [17][38] Future Outlook - Nanox anticipates that the number of clinical, demo, and commercial units will exceed 100 by the end of 2025, assuming stable macroeconomic conditions [16]

Financial Data and Key Metrics Changes - The company reported a GAAP net loss of $14.1 million for Q4 2024, compared to a net loss of $10.2 million in Q4 2023, primarily due to an increase in gross loss and other expenses [53][54] - Revenue for the reported period was $3.0 million, with a gross loss of $2.9 million, compared to revenue of $2.4 million and a gross loss of $1.7 million in the comparable period [55] - Non-GAAP gross loss for the reported period was $0.3 million, compared to a gross profit of $0.9 million in the comparable period, indicating a significant decline in gross profit margin [55] Business Line Data and Key Metrics Changes - Revenue from teleradiology services was $2.8 million with a gross profit of $0.6 million, up from $2.3 million and a gross profit of $0.3 million in the comparable period, reflecting improved gross profit margins [55] - Revenue from the sale and deployment of imaging systems amounted to $136,000, a significant increase from $17,000 in the comparable period, driven by sales of 2D systems and OEM projects [56] - Revenue from AI solutions was $83,000, consistent with the previous period, but with a slight decrease in non-GAAP gross profit [56] Market Data and Key Metrics Changes - The company has expanded its commercial coverage in the U.S. to seven states, with a focus on small and medium-sized medical imaging centers and multi-specialty medical centers [19][77] - The company is actively pursuing entry into the European market following the CE mark certification, with new distribution agreements signed in Romania and Greece [31][92] Company Strategy and Development Direction - The primary focus remains on accelerating the deployment of the Nanox. ARC and AI solutions in the U.S. while expanding into the European market [17][24] - The company aims to enhance its market presence through strategic partnerships and channel agreements, particularly in the durable medical equipment space [22][23] - The company is committed to generating clinical validation and raising awareness of its technology among healthcare professionals [27][28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about 2025 being a strong year for AI solutions and emphasized the importance of regulatory milestones and market education [103][118] - The company is focused on building a robust pipeline and converting installations into revenue-generating scans [89][118] - Management highlighted the positive feedback from customers and the potential for the Nanox. ARC to transform the medical imaging market [123] Other Important Information - The company ended the quarter with approximately $83.5 million in cash and cash equivalents, indicating a solid financial position to support ongoing operations [58] - The company issued approximately 5 million ordinary shares, raising gross proceeds of $38.8 million under its sales agreement [60] Q&A Session Summary Question: Can you elaborate on the DME partners in the U.S.? - The company will offer both CapEx direct sales and traditional models through DME partners [66][67] Question: How many systems were deployed in the U.S. during the quarter? - Exact numbers were not disclosed, but the company indicated that installations are in various stages and that the pipeline remains robust [85][86] Question: What is the pricing strategy for ARC in Europe? - The company expects most sales in Europe to be CapEx sales, with installations likely starting in the next two quarters [90][92] Question: What is the outlook for 2025? - Management refrained from providing specific guidance but indicated that 2025 is expected to be a meaningful year for growth, particularly in AI and imaging solutions [96][104] Question: Can you discuss the capital raised and its deployment? - Approximately $38 million was raised, which will be used to accelerate commercialization efforts for both imaging and AI products [116][118]