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].

Financial Performance - Scanner sales revenue for Q3 2024 was $0.9 million, with a gross margin of 65%[1] - Total commercial revenue for Q3 2024 was $1.0 million, down from $1.7 million in Q2 2024 and less than $0.1 million in Q3 2023[7] - Net loss for Q3 2024 was $3.6 million, compared to a net loss of $1.4 million in Q3 2023[7] - Non-GAAP Adjusted EBITDA for Q3 2024 was $(2.2) million, compared to $(0.6) million in Q3 2023[7] - The company reported a net loss of $9,166,000 for the nine months ended September 30, 2024, compared to a net loss of $4,589,000 for the same period in 2023, indicating an increase in losses of approximately 99.5%[19] Financing Activities - The company completed a $2.56 million PIPE financing, executed by the Board of Directors, at a 10% premium to the prior five-day average trading price[4] - The principal balance of the convertible note was reduced to $8.6 million after a payment of approximately $1.5 million[3] - The company raised $10,525,000 from long-term debt financing during the nine months ended September 30, 2024[19] Assets and Liabilities - As of September 30, 2024, total assets increased to $6,960,000 from $6,706,000 as of December 31, 2023, representing a growth of approximately 3.78%[18] - Cash and restricted cash and cash equivalents at the end of the period were $1,564,000, up from $54,000 at the end of the same period last year, reflecting a significant increase[19] - Total current liabilities decreased to $5,433,000 from $7,338,000, a reduction of approximately 26%[18] - Long-term debt increased significantly to $3,469,000 from $96,000, marking an increase of over 3,500%[18] Inventory and Operations - Operating cash used in Q3 2024 was $1.9 million, compared to $0.4 million in Q3 2023[7] - The company experienced a decrease in inventory from $4,418,000 to $3,182,000, a reduction of approximately 28%[18] - The company shipped two QT Breast Acoustic CT Scanners to clinical sites during Q3 2024, contributing to revenue growth[3] Future Plans and Development - The company plans to maintain revenue delivery in Q4 2024 at the same pace as previous quarters, with an expected higher gross margin[11] - The company plans to commercialize the QT Imaging Breast Acoustic CT™ Scanner and expand its product offerings, with a focus on large-scale manufacturing and further development[20] - The company signed a third-year renewal of its five-year research grant from the NIH/NCI during Q3 2024[8] Strategic Focus - Adjusted EBITDA is not provided due to the inability to forecast the most directly comparable GAAP measure without unreasonable effort[29] - The company emphasizes the importance of medical imaging for disease detection and treatment, aiming to improve global health outcomes through innovative body imaging systems[31]

Financial Performance - The company has incurred a net loss of $5,547,464 and used $6,955,081 of cash in operating activities during the six months ended June 30, 2024, with an accumulated deficit of $28,503,111 as of the same date [147]. - Net loss for the three months ended June 30, 2024, was $1,248,874, a decrease of $81,140 compared to a net loss of $1,330,014 in the same period in 2023 [179]. - Revenue increased by $1,710,852 to $1,714,035 for the three months ended June 30, 2024, compared to $3,183 for the same period in 2023, primarily due to the sale of four QT Breast Scanners [175]. - Revenue for the six months ended June 30, 2024, increased by $3,065,451 to $3,076,198, compared to $10,747 for the same period in 2023, due to the sale of seven QT Breast Scanners [186]. - Cost of revenue increased by $836,363 to $839,484 for the three months ended June 30, 2024, from $3,121 in the same period in 2023, driven by the sale of four QT Breast Scanners [176]. - Cost of revenue for the six months ended June 30, 2024, increased by $1,391,869 to $1,441,567, from $49,698 in 2023, primarily due to the sale of seven QT Breast Scanners [189]. - Selling, general and administrative expenses increased by $1,320,710 to $2,169,541 for the three months ended June 30, 2024, from $848,831 in 2023, attributed to higher professional services and employee compensation costs [178]. - Selling, general and administrative expenses for the six months ended June 30, 2024, increased by $5,725,156 to $7,865,752, from $2,140,596 in 2023, largely due to non-recurring transaction expenses related to a business combination [191]. - Interest expense, net increased by $1,432,139 to $1,694,009 for the six months ended June 30, 2024, from $261,870 in 2023, driven by increased amortization of debt discount [194]. Financing Activities - The company raised a private secured convertible bridge financing of $1,000,000 on November 10, 2023, with four of the five investors opting for cash repayment totaling $960,000, while one investor converted $200,000 into 100,000 shares of common stock [151][152]. - On November 15, 2023, the company entered into a Standby Equity Purchase Agreement allowing the sale of up to $50 million of common stock over 36 months following the Business Combination [155]. - The company received a Pre-Paid Advance of $9,025,000 from Yorkville, accruing interest at 6%, with a potential increase to 18% upon default [155]. - The company received a Pre-Paid Advance of $9,025,000 from Yorkville and $1,500,000 from Cable Car, contributing to a total of $10,525,000 in financing arrangements [197]. - The company has access to an additional $40 million of potential capital through the Standby Equity Purchase Agreement with Yorkville [197]. - The company issued convertible promissory notes with a total balance of $3,294,659 as of December 31, 2023, net of unamortized debt issuance costs [201]. - The company anticipates that the additional cash received will be sufficient to fund its current operating plan for at least the next 12 months [197]. - Net cash provided by financing activities was $11,398,512 for the six months ended June 30, 2024, primarily due to proceeds from long-term debt and the Merger [215]. Research and Development - The company expects research and development expenses to increase substantially as it invests in the development of the QT Breast Scanner and a full-body scanner for orthopedic and pediatric use [170]. - The company expects to incur significant expenses related to ongoing research and development, regulatory clearances, and building a U.S. sales and marketing team [216]. - The company has a strategy to support Direct-to-Customer and Direct-to-Patient approaches to lower healthcare costs and increase access to personal medical imaging [142]. - The company plans to continue investing additional resources into its products, which may affect future cost of revenue [169]. - As of the date of the report, the company cannot reasonably determine the costs necessary to complete enhancements of the QT Breast Scanner or the full-body scanner development [171]. Partnerships and Agreements - 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 four QT Breast Scanners delivered to NXC's customers as of June 30, 2024 [142][144]. - The company plans to engage in a good faith discussion to develop a binding Original Equipment Manufacturer (OEM) agreement with Canon Medical Systems, targeting execution in the second half of 2024 [146]. - The company has entered into a Feasibility Study Agreement with Canon Medical Systems to evaluate the business, technical, and clinical values of the QT Breast Scanner, which will remain in force until the end of December 2024 [145]. - The company entered into a Distribution Agreement with NXC, appointing them as the exclusive reseller for certain equipment in the U.S. until December 31, 2025 [167]. Operational Challenges - The company has been operating with negative cash flows from operations since inception and will need to continue raising additional capital to achieve profitability [147]. - Future funding requirements will depend on factors such as cash availability for debt obligations, manufacturing expansion, and regulatory clearance costs [219]. - If financing is not available at acceptable levels, the company may need to reduce operating expenses or delay development programs [218]. - The company is unable to estimate exact operating capital requirements due to numerous risks and uncertainties in manufacturing and commercialization [219]. - The ability to continue as a going concern is dependent on securing financing and achieving profitable operations [221]. Internal Controls and Compliance - The company identified a material weakness in internal control over financial reporting due to lack of segregation of duties around key accounting processes, attributed to limited personnel resources [243]. - A second material weakness was identified related to technical accounting aspects of certain material transactions during the review of condensed consolidated financial statements for the three months ended March 31, 2024 [243]. - Remedial measures have been initiated, including implementing technology, hiring personnel, and engaging external resources to address the identified weaknesses [243]. - No misstatements were found in the condensed consolidated financial statements as of June 30, 2024, despite the identified material weaknesses [244]. - There were no changes in internal control over financial reporting that materially affected the company's controls during the three months ended June 30, 2024 [245]. - The effectiveness of internal control systems is subject to inherent limitations, including the exercise of judgment and resource constraints [246]. - The company plans to continue monitoring and upgrading internal controls as necessary but cannot assure that improvements will be sufficient for effective internal control over financial reporting [246]. Legal and Regulatory Matters - The company is not currently subject to any material legal proceedings, nor are any threatened against it or its officers [248].

Financial Performance - Commercial revenue for Q2 2024 was $1.7 million, up from $1.4 million in Q1 2024 and significantly higher than less than $0.1 million in Q2 2023[3] - Gross margin in Q2 2024 was 51%, down from 56% in Q1 2024, attributed to variability in the weighted average cost of existing inventory[3][4] - Net loss for Q2 2024 was $1.2 million, compared to a net loss of $1.3 million in Q2 2023[4] - Non-GAAP Adjusted EBITDA for Q2 2024 was $(2.1) million, compared to $(0.7) million in Q2 2023[4] - Net loss for the three months ended June 30, 2024, was $1,249,000, compared to a loss of $1,330,000 for the same period in 2023, representing a decrease of 6.1%[12] - Adjusted EBITDA for the six months ended June 30, 2024, was $(3,281,000), compared to $(1,739,000) for the same period in 2023, indicating a decline of 88.5%[12] Cash Flow and Assets - The company reported a net cash usage of $1.0 million in operating activities during Q2 2024, compared to $0.5 million in Q2 2023[4] - Cash and restricted cash and cash equivalents at the end of the period were $4,601,000, up from $256,000 at the end of the previous year, marking a significant increase of 1,698.4%[17] - The company reported a net cash used in operating activities of $(6,955,000) for the six months ended June 30, 2024, compared to $(1,521,000) for the same period in 2023, indicating a worsening cash flow situation[17] - Total current assets increased to $9,494,000 as of June 30, 2024, from $4,819,000 as of December 31, 2023, reflecting a growth of 97.8%[15] - The company recorded a significant increase in accounts receivable of $669,000 during the six months ended June 30, 2024, indicating potential challenges in cash collection[17] Partnerships and Product Development - A partnership was signed with the University of Oklahoma and OU Health Stephenson Cancer Center to enhance cancer detection and treatment precision[1][2] - The company delivered four Breast Acoustic CT scanners in Q2 2024, increasing the number of commercial locations in the U.S. to five[2] - A distribution agreement was established with NXC Imaging, Inc. for exclusive resale of QT Breast Acoustic CT Scanners in the U.S.[5][7] - The company plans to commercialize the QT Imaging Breast Acoustic CT™ Scanner, with expectations for future product sales growth and revenue projections[18] Expenses and Liabilities - Research and development expenses for Q2 2024 were $925,000, compared to $349,000 in Q2 2023[10] - Total liabilities rose to $16,939,000 as of June 30, 2024, compared to $12,018,000 at the end of 2023, an increase of 41.1%[15] - The company incurred transaction expenses of $4,301,000 related to the merger with GigCapital5, Inc., which closed on March 4, 2024[12] Financial Definitions and Guidance - QT Imaging reported that EBITDA is defined as loss before interest expense, income tax expense, depreciation, and amortization[23] - Adjusted EBITDA further adjusts EBITDA for equity-based compensation, net change in fair value of derivative, earnout and warrant liabilities, and transaction expenses[23] - The company does not provide guidance for net income (loss) or reconciliation of Adjusted EBITDA guidance due to unpredictability of GAAP amounts[25] - Non-GAAP financial measures are used to provide supplemental information about financial performance and allow for comparison of results between periods[22] - Management uses non-GAAP measures to analyze financial and business trends, but acknowledges limitations in excluding significant expenses and income required by GAAP[24] - QT Imaging's financial measures may not be comparable to those of other companies due to different calculations of non-GAAP measures[21] - The financial information presented is unaudited and should be read in conjunction with GAAP measures[20] Company Vision and Strategy - QT Imaging is focused on the research, development, and commercialization of innovative body imaging systems using low frequency sound waves[27] - The company's strategy emphasizes that medical imaging should be safe, affordable, accessible, and centered on the patient's experience[27] - The company aims to improve global health outcomes through its innovative imaging technology[27]

Table of Contents As filed with the U.S. Securities and Exchange Commission on May 17, 2024. Registration No. 333-278460 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 3 to FORM S-1 REGISTRATION STATEMENT UNDER 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) Delaware 6770 85-1728920 (Primary Standard Industrial Classification Code No.) (I.R.S. Empl ...

Table of Contents As filed with the U.S. Securities and Exchange Commission on May 16, 2024. Registration No. 333-278460 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 2 to FORM S-1 REGISTRATION STATEMENT (Exact Name of Registrant as Specified in its Charter) (State or Other Jurisdiction of Incorporation or Organization) Delaware 6770 85-1728920 (Primary Standard Industrial Classification Code No.) (I.R.S. Employer Identification No.) Dr. Raluca Dinu Chief Executive Of ...

Financial Performance - The company has incurred a net loss of $4,298,590 and used $5,975,515 in cash for operating activities during the three months ended March 31, 2024, with an accumulated deficit of $22,068,735 as of the same date [174]. - Revenue increased to $1,362,163 for Q1 2024, up from $7,564 in Q1 2023, primarily due to the sale of three QT Breast Scanners [212]. - Cost of revenue rose to $602,083 in Q1 2024, compared to $46,577 in Q1 2023, driven by the sale of the QT Breast Scanners [213]. - Net loss for Q1 2024 was $4,298,590, compared to a net loss of $1,882,947 in Q1 2023, reflecting a 128% increase in losses [211]. - As of March 31, 2024, the accumulated deficit was $22,068,735, up from $17,770,145 as of December 31, 2023 [222]. - The company expects to remain cash flow negative for the foreseeable future, despite potential positive quarterly cash flows [222]. - Net cash used in operating activities for the three months ended March 31, 2024 was $5,975,515, significantly higher than $992,716 for the same period in 2023 [240][241]. - Net cash provided by financing activities for the three months ended March 31, 2024 was $11,431,060, primarily due to $10,525,000 from long-term debt issuance and $1,238,530 from the Merger [240][244]. Funding and Capital Structure - The company received nearly $18 million in financial support from the U.S. National Institutes of Health to develop a novel body imaging technology [167]. - The company raised $1,000,000 through a private secured convertible bridge financing, with four of five investors opting for cash repayment totaling $960,000 [178]. - QTI Holdings entered into a Standby Equity Purchase Agreement allowing the sale of up to $50.0 million of common stock over 36 months post-Business Combination [182]. - A pre-paid advance of $9,025,000 was received from Yorkville, accruing interest at 6% annually, convertible into common stock [182]. - A Pre-Paid Advance of $10,000,000 was received from Yorkville in March 2024, with an annual interest rate of 6% [232]. - The company anticipates that additional financing may be required in the future, which could involve restrictive covenants and potential dilution for existing shareholders [224]. - The company has an outstanding balance of $1,560,000 on the Extension Note, which does not bear interest and cannot be repaid prior to the repayment of the Pre-Paid Advance from Yorkville [239]. - As of March 31, 2024, the outstanding amount of the 2020 Notes was $3,143,725 with accrued interest of $420,700 [237]. Research and Development - Research and development expenses are expected to increase substantially as the company invests in the QT Breast Scanner and a full-body scanner for orthopedic and pediatric use [205]. - Research and development expenses increased by 52% to $642,546 in Q1 2024 from $421,887 in Q1 2023, mainly due to higher employee compensation costs [214]. - The company plans to continue incurring substantial costs for research and development, particularly for the QT Breast Scanner, and expects to raise additional capital through equity and debt financing [246][247]. Sales and Marketing - The company entered into a Sales Agent Agreement with NXC Imaging for the sale of QT Imaging products in the U.S. and U.S. territories, delivering one QT Breast Scanner to a customer as of March 31, 2024 [170]. - The company has entered into the NXC Agreement to enhance sales and marketing capabilities in the U.S. market for its products [246]. - A non-binding letter of intent was signed with Canon Medical Systems for the acquisition of two QT Breast Scanners, with 50% of the payment completed by January 31, 2024 [171]. - The company has engaged in a Feasibility Study Agreement with Canon to evaluate the QT Breast Scanner's business, technical, and clinical values, which will last until December 2024 [172]. Expenses and Cost Management - Selling, general and administrative expenses are anticipated to rise to support expanding headcount and operations, and the development of a commercial infrastructure [209]. - Selling, general and administrative expenses surged by 341% to $5,696,211 in Q1 2024 from $1,291,765 in Q1 2023, largely due to transaction expenses related to a business combination [215]. - The company anticipates that cost of revenue will increase in absolute dollars but decrease as a percentage of revenues over time due to new manufacturing processes [202]. Accounting and Compliance - The company prepares its condensed consolidated financial statements in accordance with GAAP, requiring estimates and judgments that may materially affect reported amounts of assets, liabilities, revenues, and expenses [260]. - The company is classified as an emerging growth company under the JOBS Act, allowing it to delay adopting new accounting standards [257]. - Stock-based compensation is measured at grant date fair market value and recognized as expense over the requisite service period [275]. - The company adopted ASU 2020-06 effective January 1, 2024, with no material impact on financial statements [276]. - ASU No. 2023-07, effective after December 15, 2023, requires incremental segment information disclosures, currently under evaluation for impact [277]. - ASU 2023-09, effective after December 15, 2024, aims to improve income tax disclosures, with the company evaluating its impact [278].

Financial Performance - Commercial revenue for Q1 2024 was $1.4 million, a significant increase from less than $0.1 million in Q1 2023[8] - Gross margin improved to 56% in Q1 2024, compared to a negative margin in Q1 2023, due to the sale of three QT Breast Scanners[8] - Net loss for Q1 2024 was $4.3 million, which included $1.9 million of net non-cash income related to the change in fair value of warrants and transaction expenses of $4.3 million[10] - Non-GAAP Adjusted EBITDA for Q1 2024 was $(1.2) million, slightly worse than $(1.1) million in Q1 2023[10] - The company reported a significant increase in operating expenses to $5.7 million in Q1 2024, up from $1.3 million in Q1 2023[13] - Net loss for the three months ended March 31, 2024, was $4,299,000, compared to a net loss of $1,883,000 for the same period in 2023, indicating a 128% increase in losses[21] - The accumulated deficit increased to $(22,069,000) as of March 31, 2024, from $(17,770,000) at the end of 2023, reflecting a worsening financial position[19] Assets and Liabilities - Total assets increased to $12,857,000 as of March 31, 2024, compared to $6,706,000 as of December 31, 2023, representing an increase of 92%[19] - Cash and cash equivalents rose to $5,620,000 as of March 31, 2024, from $165,000 at the end of 2023, marking a significant increase[19] - Total current liabilities decreased to $4,371,000 as of March 31, 2024, down from $7,338,000 as of December 31, 2023, a reduction of 40%[19] - Long-term debt increased to $3,331,000 as of March 31, 2024, compared to $96,000 as of December 31, 2023, reflecting a substantial rise[19] Cash Flow - Net cash used in operating activities for the first quarter of 2024 was $5,976,000, compared to $993,000 for the same period in 2023, indicating a significant increase in cash outflow[21] - The company reported a net cash provided by financing activities of $11,431,000 for the three months ended March 31, 2024, compared to $916,000 in the same period of 2023[21] Strategic Developments - The company completed its merger with GigCapital5 on March 4, 2024, enhancing its strategic position[2] - The company delivered its first commercial sale of a QT Breast Scanner on March 7, 2024, as part of its U.S. commercialization efforts[10] - A feasibility study agreement was initiated on March 28, 2024, to evaluate the QT Breast Scanner's business, technical, and clinical values[10] - The company plans to provide guidance for the remainder of 2024 as part of the Q2 2024 earnings release[12] - The company is focused on the commercialization and further development of the QT Imaging Breast Acoustic CT™ Scanner, with plans for new product development and introduction[22] - QT Imaging anticipates future events and developments will cause assessments to change, highlighting the uncertainty in projected financial information[22] Technology and Research - The area under the receiver operating characteristic curve (AUC) for QT Imaging technology was found to be statistically non-inferior to digital breast tomosynthesis (DBT) in a recent study[11]

Table of Contents As filed with the U.S. Securities and Exchange Commission on April 24, 2024. Registration No. 333-278460 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER 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) Delaware 6770 85-1728920 (Primary Standard Industrial Classification Code No.) (I.R.S. Em ...

Table of Contents As filed with the U.S. Securities and Exchange Commission on April 2, 2024. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER 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.) ...