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].
GigCapital5(GIA) - 2025 Q1 - Quarterly Report