Financial Performance - The company has incurred a net loss of $19,694,921 and an accumulated deficit of $51,635,448 as of September 30, 2025[169]. - Revenue increased by $3,236,131 to $4,192,101 for the three months ended September 30, 2025, compared to $955,970 for the same period in 2024, primarily due to the sale of nine QT Breast Scanners in Q3 2025 versus two in Q3 2024[194]. - Cost of revenue rose to $2,389,428 in Q3 2025 from $350,667 in Q3 2024, reflecting an increase of 581%[193]. - Gross profit for the three months ended September 30, 2025, was $1,802,673, up 198% from $605,303 in the same period of 2024[193]. - Revenue increased by $6,617,762 to $10,649,930 for the nine months ended September 30, 2025, representing a 164% increase compared to the same period in 2024[205]. - Cost of revenue increased by $3,416,084 to $5,208,318 for the nine months ended September 30, 2025, a 191% increase from the prior year[206]. - Gross profit for the nine months ended September 30, 2025, was $5,441,612, up 143% from $2,239,934 in 2024[204]. - Loss from operations improved by 29% to $(1,652,079) in Q3 2025, compared to $(2,327,188) in Q3 2024[193]. - Interest expense decreased by 61% to $(564,725) in Q3 2025 from $(1,455,306) in Q3 2024[193]. - Interest expense, net decreased by $1,514,301 to $1,635,014 for the nine months ended September 30, 2025, a 48% decrease from the prior year[213]. Agreements and Partnerships - The company entered into a Distribution Agreement with Gulf Medical Co. for exclusive rights to market QT Breast Scanners in Saudi Arabia for an initial term of three years[168]. - The NXC Distribution Agreement allows NXC to market and resell QT Breast Scanners in the U.S. and U.S. territories[165]. - The Gulf Medical Distribution Agreement could result in cash inflows of $11.2 million to $12.3 million in 2026 if minimum purchase requirements are met[217]. - The company expects cash inflows of up to $18.0 million in 2025 and $27.0 million in 2026 from the amended distribution agreement with NXC[216]. - The Canon Manufacturing Agreement with Canon Medical Systems, Inc. appoints CMSC as the exclusive manufacturer of QT Breast Scanners through December 31, 2026[166]. Expenses and Financial Obligations - The company expects to incur additional recurring administrative expenses associated with being a publicly traded company[170]. - Selling, general and administrative expenses rose by 25% to $2,515,994 in Q3 2025, compared to $2,007,277 in Q3 2024[193]. - Total operating expenses increased by 18% to $3,454,752 in Q3 2025 from $2,932,491 in Q3 2024[193]. - Research and development expenses increased slightly by 1% to $938,758 in Q3 2025 from $925,214 in Q3 2024[193]. - Research and development expenses increased by $198,862 to $2,691,704 for the nine months ended September 30, 2025, an 8% increase year-over-year[207]. - The company anticipates that cash received from various private placements will be sufficient to fund its operating plan for at least the next 12 months[220]. - Future funding requirements will depend on factors such as debt repayment, manufacturing expansion, and regulatory progress[242]. - The company plans to raise additional capital through equity issuance, borrowings, and strategic alliances, with potential dilution of stockholder interests[243]. - The company is subject to risks that could impact its ability to secure financing and continue operations[247]. Capital and Financing Activities - The company entered into a credit agreement for a senior secured term loan of $10,100,000 at an interest rate of 10.0% per annum, maturing on March 31, 2027[174]. - The company issued 2,232,243 shares of common stock at a purchase price of $4.50 per share during the October 2025 Private Placement, generating approximately $18,180,655 in gross proceeds[183]. - The company recorded a loss of $6,640,384 upon issuance of the Lynrock Lake Term Loan, including debt issuance costs[228]. - The outstanding amount of the Lynrock Lake Term Loan as of September 30, 2025, was $5,272,879, net of unamortized debt discount[228]. - The company repaid the Tranche B loan of $5.0 million on October 6, 2025, plus accrued interest and a 6% premium[230]. - As of September 30, 2025, the outstanding amount of the 2020 Notes was $3,190,112, with accrued interest of $679,215[232]. - During the nine months ended September 30, 2025, net cash provided by financing activities was $6,447,686, mainly from $15,000,000 in long-term debt issuance[239]. - For the nine months ended September 30, 2024, net cash provided by financing activities was $10,220,475, primarily due to $10,525,000 from long-term debt issuance and $1,238,530 from a business combination[240]. Operational Insights - The company aims to create disruptive technological innovations to improve medical imaging and healthcare quality[167]. - The company has modified the Fixed Price for conversion of the Yorkville Note to $1.752 per share for a portion of the outstanding balance[171]. - The company has no off-balance sheet arrangements during the periods presented[248]. - The company leases its operating facilities in Novato, California, under a non-cancelable lease through May 31, 2027[249]. - Net cash used in operating activities was $5,857,572 for the nine months ended September 30, 2025, a decrease from $8,806,402 for the same period in 2024[234]. - Net cash used in investing activities increased to $46,818 for the nine months ended September 30, 2025, compared to $34,590 for the same period in 2024, primarily for property and equipment purchases[238]. - Other expense, net increased by $8,579,184 to $8,770,514 for the nine months ended September 30, 2025, primarily due to extinguishment losses and noncash expenses[209]. - The company has a minimum purchase requirement with GMC that may be reduced if the company cannot deliver sufficient quantities of approved products[218].

Financial Performance - Generated revenue of $4.2 million in Q3 2025, representing a 339% year-over-year growth and a 15% sequential growth from Q2 2025[8] - Revenue for the three months ended September 30, 2025, was $4,192,000, a significant increase from $956,000 in the same period of 2024, representing a growth of 338%[21] - Gross profit for the three months ended September 30, 2025, was $1,803,000, compared to $605,000 in 2024, indicating an increase of 198%[21] - The company reaffirmed its revenue forecast of $18 million for 2025 and increased its 2026 revenue outlook from $27 million to $39 million[6] Operating Expenses and Losses - Total operating expenses for Q3 2025 were $3.5 million, an 18% increase from $2.9 million in Q3 2024[8] - Net loss for Q3 2025 was $4.6 million, or $(0.47) per share, compared to a net loss of $3.6 million, or $(0.51) per share, in Q3 2024[8] - The net loss for the three months ended September 30, 2025, was $4,557,000, compared to a net loss of $3,619,000 in 2024, reflecting a deterioration of 26%[21] - Net loss for the nine months ended September 30, 2025, was $19,695,000, compared to a net loss of $5,497,000 in 2024, representing an increase of 258%[27] Assets and Liabilities - Total current assets as of September 30, 2025, increased to $11,288,000 from $4,917,000 as of December 31, 2024, representing a growth of 129%[25] - Total liabilities as of September 30, 2025, were $21,197,000, up from $15,625,000 as of December 31, 2024, indicating an increase of 36%[25] - Cash and cash equivalents as of September 30, 2025, were $1,715,000, an increase from $1,172,000 as of December 31, 2024[25] Financing Activities - Secured $18.2 million in gross proceeds from a private placement financing, enhancing the financial position[3] - Proceeds from long-term debt, net of issuance costs, were $15,000,000 in 2025, up from $10,525,000 in 2024, indicating a growth of 42%[27] - Net cash provided by financing activities was $6,448,000 in 2025, down from $10,220,000 in 2024, a decline of 37%[27] - The company reported a repayment of long-term debt of $4,688,000 in 2025, compared to $1,243,000 in 2024, indicating an increase of 276%[27] Research and Development - Research and development expenses for the three months ended September 30, 2025, were $939,000, slightly up from $925,000 in the same period of 2024[21] Management Changes - Appointed Jay Jennings as Chief Financial Officer and Satrajit Misra as Chief Commercial Officer, bringing nearly 60 years of combined experience[2] Strategic Initiatives - Entered into an exclusive distribution agreement with Gulf Medical Co. for the QTI Breast Acoustic CT™ scanners in Saudi Arabia[3] - Submitted an application to relist on Nasdaq, including a 3:1 reverse stock split to meet listing requirements[3] Other Financial Metrics - Adjusted EBITDA for the three months ended September 30, 2025, was $(1,397,000), an improvement from $(2,163,000) in the same period of 2024[23] - The company incurred interest expense of $565,000 for the three months ended September 30, 2025, down from $1,455,000 in the same period of 2024[23] - Stock-based compensation increased to $519,000 in 2025 from $166,000 in 2024, reflecting a significant rise of 212%[27] - The company reported a loss on issuance of the Lynrock Lake Term Loan amounting to $6,640,000, which was not present in the previous year[27] - Change in fair value of warrant liability resulted in a gain of $3,581,000 in 2025, compared to a loss of $200,000 in 2024[27] - The company experienced a decrease in accounts receivable by $3,177,000 in 2025, compared to a decrease of $256,000 in 2024[27] - Net cash used in operating activities decreased to $5,858,000 in 2025 from $8,806,000 in 2024, showing an improvement of 33%[27] - Cash and restricted cash and cash equivalents at the end of the period increased to $1,735,000 in 2025 from $1,564,000 in 2024, a rise of 11%[27]

As filed with the U.S. Securities and Exchange Commission on November 3, 2025. Registration No. 333- FORM S-1 REGISTRATION STATEMENT UNDER UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 THE SECURITIES ACT OF 1933 QT Imaging Holdings, Inc. (Exact Name of Registrant as Specified in its Charter) (State or Other Jurisdiction of Incorporation or Organization) (Primary Standard Industrial Classification Code No.) Delaware 6770 85-1728920 (I.R.S. Employer Identification No.) Dr. Raluca Din ...

Financial Performance - The company has incurred a net loss of $15,137,515 and an accumulated deficit of $47,078,042 as of June 30, 2025[154]. - Revenue for the three months ended June 30, 2025, increased by $1,945,379 to $3,659,414, a 113% increase compared to $1,714,035 for the same period in 2024, primarily due to the sale of eight QT Breast Scanners[172]. - Cost of revenue for the same period increased by $992,853 to $1,832,337, an 118% increase from $839,484 in 2024, attributed to the higher sales volume of QT Breast Scanners[174]. - Gross profit for the three months ended June 30, 2025, was $1,827,077, reflecting a 109% increase from $874,551 in 2024[172]. - Net loss for the three months ended June 30, 2025, was $4,001,515, a 220% increase compared to a net loss of $1,248,874 in 2024[172]. - For the six months ended June 30, 2025, revenue increased by $3,381,631 to $6,457,829, a 110% increase from $3,076,198 in 2024[182]. - Cost of revenue rose by $1,377,323 to $2,818,890 for the six months ended June 30, 2025, from $1,441,567 in the prior year, reflecting the increased sales of QT Breast Scanners[184]. - Other expense, net increased by $8,531,630 to $8,739,955 for the six months ended June 30, 2025, primarily due to extinguishment losses and non-cash expenses related to the Lynrock Lake Term Loan[187]. Expenses - Research and development expenses decreased by $24,388 to $900,694 for the three months ended June 30, 2025, a 3% decrease from $925,082 in 2024[175]. - Selling, general and administrative expenses decreased by $200,179 to $1,969,362 for the three months ended June 30, 2025, a 9% decrease from $2,169,541 in 2024[176]. - Research and development expenses increased by $185,318 to $1,752,946 for the six months ended June 30, 2025, primarily due to employee compensation costs[185]. - Selling, general and administrative expenses decreased by $3,895,049 to $3,970,703 for the six months ended June 30, 2025, mainly due to reduced professional services costs[186]. - Interest expense, net decreased by $623,720 to $1,070,289 for the six months ended June 30, 2025, driven by lower interest expenses on various notes[191]. Funding and Capital Requirements - The company continues to incur losses and will need to raise additional capital to achieve profitability[154]. - The company expects cash inflows of up to $18.0 million in 2025 and $27.0 million in 2026 from the Amended Distribution Agreement with NXC[194]. - The company plans to raise additional capital through equity issuance, borrowings, and potential strategic alliances[216]. - Future funding requirements will depend on various factors, including the ability to repay debt obligations, expand manufacturing operations, and seek regulatory clearances for product candidates[217]. - If additional funds are not raised when needed, the company may be required to delay or eliminate product development efforts[221]. Product Development and Regulatory Matters - The company plans to create disruptive technological innovations to improve medical imaging quality and access[153]. - The company expects to incur significant expenses related to research and development, regulatory clearances for the QT Breast Scanner, and building a U.S. sales and marketing team[215]. - The QT Breast Scanner is a Class II device that received FDA clearance as substantially equivalent to a predicate device on June 6, 2017[150]. Agreements and Partnerships - The company entered into a Distribution Agreement with NXC Imaging, appointing NXC as the exclusive reseller of QT Breast Scanners in the U.S. and U.S. territories[151]. - The Canon Manufacturing Agreement with Canon Medical Systems, Inc. appoints CMSC as the exclusive manufacturer of QT Breast Scanners until December 31, 2026[152]. Cash Flow and Operating Activities - Net cash used in operating activities for the six months ended June 30, 2025, was $4,978,822, a decrease of approximately 29% compared to $6,955,081 for the same period in 2024[208][209]. - Net cash provided by financing activities for the six months ended June 30, 2025, was $5,875,716, primarily due to $10,000,000 of net proceeds from the issuance of long-term debt related to the Lynrock Lake Term Loan[212]. - Net cash used in investing activities was $46,818 for the six months ended June 30, 2025, compared to $26,977 for the same period in 2024, primarily related to the purchase of property and equipment[211]. Litigation and Compliance - The company is subject to ongoing litigation, but management is not aware of any pending claims that will have a material impact on financial statements[225]. - The company remains an emerging growth company under the JOBS Act, allowing it to delay adopting new accounting standards[226]. Debt Obligations - A senior secured term loan of $10,100,000 was secured with an interest rate of 10.0% per annum, maturing on March 31, 2027[158]. - The Lynrock Lake Term Loan was established for $10.1 million at a 10% annual interest rate, maturing on March 31, 2027[197]. - The outstanding amount of the 2020 Notes was $3,143,725 as of June 30, 2025, with accrued interest of $635,815[205]. - The total principal amount outstanding under the Working Capital Note as of December 31, 2023, is $705,000, which was issued to provide additional working capital prior to the Business Combination Agreement with GigCapital5[206].

Financial Performance - Generated revenue of $3.7 million in Q2 2025, representing a 113% year-over-year growth and a 31% sequential increase from Q1 2025[6] - Achieved a gross margin of 50% in Q2 2025, slightly down from 51% in Q2 2024 due to variability in inventory costs[10] - Total operating expenses for Q2 2025 were $2.9 million, a 7% improvement from $3.1 million in Q2 2024[10] - Net loss of $4.0 million in Q2 2025, compared to a net loss of $1.2 million in Q2 2024[11] - Non-GAAP Adjusted EBITDA for Q2 2025 was $(0.8) million, an improvement from $(2.1) million in Q2 2024[14] - The company reported a net loss of $15,138,000 for the six months ended June 30, 2025, compared to a net loss of $1,877,000 for the same period in 2024, indicating a significant increase in losses[26] - Cash and restricted cash and cash equivalents at the end of the period were $2,042,000, down from $4,601,000 at the end of June 30, 2024, reflecting a decrease of 56%[26] - The company recorded a loss of $6.6 million upon the issuance of the Lynrock Lake Term Loan for the six months ended June 30, 2025[23] Assets and Liabilities - The company has cash of $4.3 million as of August 6, 2025, following collections from scanner shipments[14] - As of June 30, 2025, total current assets increased to $10,668,000 from $4,917,000 as of December 31, 2024, representing a 117% increase[25] - The total liabilities decreased to $11,957,000 as of June 30, 2025, from $15,625,000 as of December 31, 2024, a reduction of 23%[25] - The earnout liability related to the Merger Earnout Consideration Shares decreased to $280,000 from $440,000, a decline of 36%[25] - The company reported a significant increase in additional paid-in capital, rising to $46,751,000 as of June 30, 2025, from $22,400,000 as of December 31, 2024, an increase of 108%[25] Business Operations - Shipped eight QT Imaging Breast Acoustic CT™ scanners in Q2 2025, in line with minimum order quantities from the distribution agreement with NXC Imaging[10] - Plans to deliver $18 million in revenue for 2025 and $27 million for 2026, with shipments of 40 and 60 scanners respectively[16] - Launched the QTI Cloud Platform, expected to provide a new source of recurring revenue through subscription fees[10] - Appointed new leadership in medical and clinical operations to strengthen the company's capabilities[10] - The company anticipates future growth through the commercialization of the QT Imaging Breast Acoustic CT™ Scanner and the development of a scalable imaging platform[27] Financial Metrics and Guidance - EBITDA is defined as loss before interest expense, income tax expense, depreciation, and amortization, while Adjusted EBITDA further adjusts for various expenses[35] - Management uses EBITDA and Adjusted EBITDA as non-GAAP performance measures, but does not provide reconciliation for forward-looking non-GAAP measures due to unpredictability[37] - No guidance for the company's net income (loss) or reconciliation of Adjusted EBITDA guidance is provided due to the inability to forecast GAAP measures without unreasonable effort[37] - The principal limitation of non-GAAP measures is that they exclude significant expenses and income required by GAAP[36] - QT Imaging believes that non-GAAP financial measures provide useful information regarding financial and business trends[35] Company Vision and Strategy - QT Imaging Holdings, Inc. is focused on the research, development, and commercialization of innovative body imaging systems using low frequency sound waves[39] - The company's strategy emphasizes the importance of safe, affordable, and accessible medical imaging for disease detection, diagnosis, and treatment[39] - The company aims to improve global health outcomes through its innovative imaging technology[39] Trademark Information - Breast Acoustic CT is a trademark of an affiliate of QT Imaging Holdings, Inc.[40]

Financial Performance - The company has incurred a net loss of $11,136,000 for the three months ended March 31, 2025, and has an accumulated deficit of $43,076,527 as of the same date[140]. - Revenue increased by $1,436,252 to $2,798,415 for the three months ended March 31, 2025, representing a 105% increase compared to $1,362,163 for the same period in 2024[158]. - Cost of revenue increased by $384,470 to $986,553 for the three months ended March 31, 2025, primarily due to the sale of six QT Breast Scanners compared to three in the prior year[160]. - Gross profit for the three months ended March 31, 2025, was $1,811,862, a 138% increase from $760,080 in the same period in 2024[158]. - Net loss and comprehensive loss for the three months ended March 31, 2025, was $11,136,000, a significant increase from a loss of $628,590 in the same period in 2024, representing a 1,672% increase[158]. - The accumulated deficit as of March 31, 2025, was $43,076,527, up from $31,940,527 as of December 31, 2024[169]. Funding and Capital Structure - The company received nearly $18 million in financial support from the U.S. National Institutes of Health for the development of its body imaging technology[133]. - A senior secured term loan of $10,100,000 was secured from Lynrock Lake at an interest rate of 10.0% per annum, with a maturity date of March 31, 2027[144]. - The company has entered into amendments with Yorkville and Cable Car to modify terms of existing promissory notes, including a reduction in conversion prices to $0.584 per share[142][143]. - The company expects cash inflows of up to $18.0 million in 2025 and $27.0 million in 2026 from the Amended Distribution Agreement with NXC[170]. - The Lynrock Lake Term Loan provided $10.1 million in principal, with $5.4 million of net proceeds available for working capital after settling obligations under the Yorkville Note and Cable Car Note[171]. - The company expects to finance cash needs through a combination of public or private equity offerings, debt financings, and strategic partnerships[193]. - If additional funds are not raised, the company may need to delay or reduce product development and commercialization efforts[195]. Research and Development - The company anticipates continued investment in product development, which may affect future costs of revenue[150]. - The company expects to incur significant expenses for research and development, particularly for the QT Breast Scanner, and plans to raise capital through equity issuance and borrowings[189]. - The company plans to continue incurring substantial costs for research and development to commercialize its products, which may require additional capital[190]. - Research and development expenses rose by $209,706 to $852,252 for the three months ended March 31, 2025, mainly due to increased employee compensation costs[161]. Operational Agreements and Partnerships - The company entered into a Distribution Agreement with NXC Imaging, appointing NXC as the exclusive reseller of QT Breast Scanners in the U.S. and U.S. territories, with 14 units delivered as of March 31, 2025[137]. - The Canon Manufacturing Agreement with Canon Medical Systems, Inc. appoints CMSC as the exclusive manufacturer of QT Breast Scanners, effective through December 31, 2026[138]. - The company focuses on expanding market access through Direct-to-Customer and Direct-to-Patient approaches to lower healthcare costs[139]. - The company is committed to improving healthcare quality and reducing costs globally through innovative imaging solutions[139]. Legal and Compliance - The company is subject to occasional lawsuits, but management is not aware of any pending claims that will materially impact financial statements[199]. - The company is classified as an emerging growth company (EGC) under the JOBS Act, allowing it to delay adopting new accounting standards[200]. - The company will remain an EGC until certain financial thresholds are met, including total annual gross revenue of at least $1.235 billion[203]. - The company does not currently have any off-balance sheet arrangements[197]. Lease and Facilities - The company leases its operating facilities in Novato, California, under a non-cancelable operating lease through May 31, 2027[198]. Risks and Uncertainties - The company is unable to estimate exact operating capital requirements due to numerous risks and uncertainties associated with manufacturing and commercialization of products[191]. - Future funding requirements may increase significantly based on factors such as debt obligations, manufacturing expansion, and regulatory clearances for the QT Breast Scanner[192]. - The company may need to relinquish valuable rights to technologies or revenue streams if it raises funds through collaborations or licensing arrangements[194].

Financial Performance - Commercial revenue for Q1 2025 was $2.8 million, a 100% increase from $1.4 million in Q1 2024, driven by the shipment of six Breast Acoustic CT scanners[5] - Gross margin improved to 65% in Q1 2025, up from 56% in Q1 2024, attributed to variability in the weighted average cost of existing inventory[5] - Net loss for Q1 2025 was $11.1 million, significantly higher than a net loss of $0.6 million in Q1 2024[5] - The company reported an adjusted EBITDA of $(0.9) million for Q1 2025, an improvement from $(1.2) million in Q1 2024[5] - Net loss for the three months ended March 31, 2025, was $11,136,000, compared to a net loss of $629,000 for the same period in 2024[20] - Cash flows from operating activities resulted in a net cash used of $3,537,000 in Q1 2025, an improvement from $5,976,000 in Q1 2024[20] - The company reported a net cash provided by financing activities of $5,353,000 in Q1 2025, down from $11,431,000 in Q1 2024[20] - Cash and restricted cash and cash equivalents at the end of Q1 2025 totaled $3,008,000, compared to $5,640,000 at the end of Q1 2024[20] - The company incurred a loss of $6,640,000 on the issuance of the Lynrock Lake Term Loan during Q1 2025[20] Operational Developments - The company closed a $10.1 million term loan with Lynrock Lake, with $5.4 million allocated for working capital purposes[2] - The company shipped six QT Breast Acoustic CT scanners in Q1 2025, fulfilling minimum order quantities under its distribution agreement with NXC Imaging[10] - The company entered into a contract manufacturing agreement with Canon Medical Systems Corporation to enhance production capabilities[2] Future Projections - The company aims to achieve $18 million in revenue for 2025, with plans to ship 40 scanners, and $27 million in revenue for 2026, with 60 scanners[10] - Adjusted EBITDA is not provided for future periods due to the unpredictability of certain GAAP components, making it impractical for the company to forecast[28] Strategic Focus - QT Imaging is focused on the commercialization and further development of the QT Imaging Breast Acoustic CT™ Scanner, with plans for large-scale manufacturing[21] - The company anticipates future product sales growth and projected revenues related to its innovative body imaging systems[21] - QT Imaging's strategy emphasizes safe, affordable, and accessible medical imaging centered on patient experience[30] - The company acknowledges risks related to the commercialization of its technology and the ability to attract qualified personnel[21]

Financial Performance and Profitability - The company has incurred significant operating losses in the past and may never achieve or maintain profitability[28] - The company has a limited operating history with its current offerings, increasing the risk of investment[28] - The company does not anticipate paying dividends on common stock, affecting potential returns for investors[33] Product Development and Market Acceptance - The company is dependent on the successful commercial launch of the QT Breast Scanner, which must achieve widespread market acceptance to generate necessary revenue[28] - The company may not successfully develop or introduce new products that achieve market acceptance, which could harm revenue[28] - The successful commercial launch of the QT Breast Scanner is critical for generating necessary revenue[28] Competition and Market Risks - The company faces risks related to increased competition and the ability to manage growth and expand operations effectively[21] - The company faces risks related to increased competition and the ability to manage growth effectively[28] Capital and Financing Needs - The company may need to incur additional indebtedness or seek capital through new equity or debt financings to support business growth[28] - The company may need to incur additional indebtedness or seek capital through new equity or debt financings to support growth[28] - The company's common stock is now quoted on the OTC Markets OTCQB Venture Market tier, which may adversely affect its ability to raise capital[33] - The common stock is now quoted on the OTC Markets OTCQB Venture Market tier, which may depress stock price and affect capital raising efforts[33] Regulatory and Compliance Risks - The company is subject to extensive government regulations, and failure to comply could result in enforcement actions that negatively impact operations[27] - Recent changes in U.S. payment policies for imaging procedures could negatively impact the utilization of the company's imaging services[28] - Recent changes in U.S. payment policies for imaging procedures could negatively impact the utilization of the company's services[28] Management and Operational Challenges - The management team has limited experience managing a publicly traded company, which may affect the company's transition and operational performance[33] - The management team has limited experience managing a publicly traded company, which could affect operational performance[33] - The company relies on third-party providers for internet infrastructure and data services, and any failure could adversely affect customer relationships[28]

Financial Performance - Generated sales of twelve scanners with revenue of approximately $5 million and a gross margin of 54% in 2024[1] - Commercial revenue for Q4 2024 was $0.8 million, down from $1.0 million in Q3 2024, and up from less than $0.1 million in Q4 2023[3] - Forecasts revenue growth of $18 million in 2025 and $27 million in 2026, corresponding to the shipment of 40 and 60 scanners, respectively[11] - Net loss for Q4 2024 was $3.5 million, compared to a net loss of $3.6 million in Q3 2024 and $1.5 million in Q4 2023[6] - The company reported a net loss of $8.985 million for the year ended December 31, 2024, compared to a net loss of $6.099 million in 2023, representing an increase in losses of approximately 47.5%[21] - The company reported a net cash used in operating activities of $10.033 million for the year ended December 31, 2024, compared to $2.651 million in 2023, indicating a significant increase in cash outflow[21] Gross Margin and Assets - Gross margin for Q4 2024 was 47%, down from 63% in Q3 2024, while the annual gross margin for 2024 was 54%[6] - Total current assets increased slightly to $4.917 million as of December 31, 2024, compared to $4.819 million in 2023, reflecting a growth of 2%[19] - Cash and restricted cash and cash equivalents at the end of the period increased to $1.192 million from $185, marking a significant increase of approximately 544%[22] Liabilities and Expenses - Total liabilities rose to $15.625 million in 2024, up from $12.018 million in 2023, indicating an increase of approximately 30%[19] - The company incurred transaction expenses of $3.7 million related to the merger with GigCapital5, Inc., which closed on March 4, 2024[21] - The earnout liability was recorded at $440,000 as of December 31, 2024, reflecting the contingent consideration for the merger[19] - The fair value of the derivative liability decreased by $4.818 million during the year ended December 31, 2024[21] Operational Developments - The company cleared all short-term debt liabilities and closed a $10.1 million term loan for working capital purposes[1] - Entered into a manufacturing agreement with Canon Medical Systems Corporation to scale up internal manufacturing capacity[9] - The company shipped twelve QT Breast Acoustic CT Scanners in 2024, compared to no shipments in 2023[3] - The company plans to commercialize the QT Imaging Breast Acoustic CT™ Scanner and expand its product offerings, with future repayment of the Lynrock Lake Term Loan anticipated[23] Investment and Funding - The company announced a PIPE investment of $2.56 million from insiders, fully funded by the Board of Directors and Management[1] - The company recorded $3.698 million in fair value of common stock issued in exchange for services during the year ended December 31, 2024[21] Strategic Focus - QT Imaging Holdings, Inc. is focused on the research, development, and commercialization of innovative body imaging systems using low frequency sound waves[32] - The Company's strategy emphasizes the importance of safe, affordable, and accessible medical imaging for disease detection, diagnosis, and treatment[32] - The Company uses EBITDA and Adjusted EBITDA as non-GAAP performance measures, but does not provide guidance for net income (loss) due to unpredictability of GAAP components[30]

Financial Performance - The company has incurred a net loss of $9,166,958 during the nine months ended September 30, 2024, with an accumulated deficit of $32,122,605[179]. - Revenue increased by $931,313 to $955,970 for the three months ended September 30, 2024, compared to $24,657 for the same period in 2023, primarily due to the sale of two QT Breast Scanners[195]. - Cost of revenue increased by $326,868 to $350,667 for the three months ended September 30, 2024, from $23,799 for the same period in 2023, attributed to the sale of two QT Breast Scanners[196]. - Net loss for the three months ended September 30, 2024, was $3,619,494, compared to a net loss of $1,375,939 for the same period in 2023, reflecting an increase of $2,243,555[198]. - Revenue increased to $4,032,168 for the nine months ended September 30, 2024, up from $35,404 in the same period of 2023, representing a change of $3,996,764[206]. - Cost of revenue rose to $1,792,234 for the nine months ended September 30, 2024, compared to $73,497 in 2023, an increase of $1,718,737[207]. - Gross profit improved to $2,239,934 for the nine months ended September 30, 2024, from a loss of $(38,093) in 2023, a change of $2,278,027[206]. - Net loss for the nine months ended September 30, 2024, was $(9,166,958), worsening from a net loss of $(4,588,900) in 2023, a change of $(4,578,058)[215]. Expenses - Research and development expenses rose by $613,385 to $925,214 for the three months ended September 30, 2024, from $311,829 for the same period in 2023, driven by increased employee compensation and professional services costs[197]. - Selling, general and administrative expenses increased by $1,075,153 to $2,007,277 for the three months ended September 30, 2024, from $932,124 for the same period in 2023, primarily due to higher employee compensation and insurance costs[199]. - Research and development expenses increased by 130% to $2,492,842 for the nine months ended September 30, 2024, from $1,083,373 in 2023[208]. - Selling, general and administrative expenses surged by 221% to $9,873,029 for the nine months ended September 30, 2024, compared to $3,072,720 in 2023[209]. - Interest expense, net increased by $1,322,462 to $1,455,306 for the three months ended September 30, 2024, from $132,844 for the same period in 2023, mainly due to increased amortization of debt discount[203]. - Interest expense increased significantly to $(3,149,315) for the nine months ended September 30, 2024, from $(394,714) in 2023, an increase of $2,754,601[213]. Financing and Capital Structure - The company has a Pre-Paid Advance of $9,025,000 from Yorkville, with a Yorkville Note accruing interest at an annual rate of 6%[181]. - The principal balance of the Yorkville Note was $8,600,000 following the conversion of $254,593 of outstanding principal into 384,059 shares of common stock at a conversion price of $0.6629 per share[184]. - The Company entered into a PIPE agreement for the issuance of shares and warrants with an aggregate purchase price of $2,560,000, resulting in the issuance of 4,383,558 shares at $0.584 per share[185]. - The company received a Pre-Paid Advance of $10,000,000 from Yorkville on March 4, 2024, as part of its financing strategy[224]. - The company made a payment of $1,521,581 to Yorkville, which included $1,145,407 of principal, $318,904 of accrued interest, and $57,270 of early payment premium[225]. - As of September 30, 2024, the outstanding amount of the Yorkville Note was $2,980,159, net of unamortized discount of $5,874,434 and accrued interest of $24,744[226]. - The company executed the Second Amendment to extend the maturity date of the Yorkville Note to March 31, 2026, with monthly payments of $500,000 plus a 5% premium starting February 15, 2025[227]. - Yorkville converted $254,593 of outstanding principal into 384,059 shares of common stock at a conversion price of $0.6629 per share, resulting in a principal balance of $8,600,000 for the Yorkville Note[228]. - Net cash used in operating activities was $8,806,402 for the nine months ended September 30, 2024, compared to $1,965,772 for the same period in 2023[236]. - Net cash provided by financing activities was $10,220,475 for the nine months ended September 30, 2024, primarily due to proceeds from long-term debt and the Merger[239]. - The company plans to raise additional capital through equity issuance, borrowings, and potential strategic alliances[242]. Strategic Partnerships and Agreements - The company entered into a Distribution Agreement with NXC Imaging, appointing them as the exclusive reseller of QT Breast Scanners in the U.S. and U.S. territories[174]. - The company plans to engage in a good faith discussion to develop a binding Original Equipment Manufacturer (OEM) agreement with Canon Medical Systems, targeted for execution in Q4 2024[178]. - The company has entered into a Feasibility Study Agreement with Canon Medical Systems to evaluate the QT Breast Scanner's business and clinical values[177]. - The company has partnered with strategic business channels to expand market access for the QT Breast Scanner, targeting hospitals and radiology centers[174]. Future Outlook and Expectations - The company expects to incur additional recurring administrative expenses as a publicly traded company, including compliance costs and audit fees[180]. - The company expects research and development expenses to increase substantially as it continues to invest in the development of the QT Breast Scanner and a full-body scanner product candidate[190]. - The Company anticipates selling, general and administrative expenses will rise to support expanding operations and commercialization efforts[194]. - The company expects to derive future liquidity primarily through revenues and the sale of equity securities[214]. - The company expects to incur significant expenses for research and development, regulatory clearances, and building a U.S. sales and marketing team[240]. - Future funding requirements will depend on various factors, including cash to repay debt obligations, manufacturing expansion, and regulatory clearances[241]. - The company is unable to estimate exact operating capital requirements due to numerous risks and uncertainties associated with product development and commercialization[243]. - The company expects to finance its cash needs through a combination of public or private equity offerings, debt financings, collaborations, and strategic partnerships[245]. Compliance and Reporting - The company is an emerging growth company (EGC) and intends to rely on exemptions and reduced reporting requirements provided by the JOBS Act until certain conditions are met[252][255]. - The company has no off-balance sheet arrangements during the periods presented[249]. - The company recognizes revenue when a customer obtains control of promised goods or services, with performance obligations including product sales and maintenance contracts[258][259]. - The company evaluates the realizability of deferred tax assets annually, assessing the likelihood of realization based on future taxable income forecasts[263]. - The company adopted ASU 2020-06 effective January 1, 2024, with no material impact on its condensed consolidated financial statements[265]. - The company is currently evaluating the impact of ASU No. 2023-07 on its financial statements, which requires incremental segment information disclosures[266]. - The company plans to adopt ASU 2023-09 on a prospective basis, aimed at improving income tax disclosures[267]. - The company is subject to occasional lawsuits and claims but is not aware of any pending claims that will materially impact its financial statements[251].