Financial Performance - As of September 30, 2025, the company reported an accumulated deficit of $92.3 million, up from $70.6 million as of December 31, 2024[302]. - For the three months ended September 30, 2025, the net loss was $(10.1) million, while for the nine months, it was $(21.8) million[302]. - The company has incurred net losses each year since its inception in 2011, indicating ongoing financial challenges[302]. - Revenue was nil for the three months ended September 30, 2025, compared to $0.1 million and $53.0 thousand for the same periods in 2024, representing a decrease of $0.2 million[343]. - Total cost of revenue and operating expenses for the three months ended September 30, 2025, was $5.7 million, a decrease of $5.1 million, or 47.1%[342]. - Net loss for the three months ended September 30, 2025, was $10.1 million, compared to a net income of $3.6 million for the same period in 2024, representing a change of $13.7 million[342]. - For the nine months ended September 30, 2025, net cash used in operating activities was $14.9 million, primarily due to a net loss of $21.8 million[397]. - The company experienced a net change in cash and cash equivalents of $(15.9) million for the nine months ended September 30, 2025[396]. Funding and Capital Structure - The company raised approximately $19 million in a private placement, with potential additional proceeds of up to $31 million from future warrant exercises[304][309]. - The company announced a Private Placement on October 20, 2025, resulting in gross proceeds of approximately $19 million to enhance liquidity for operations[364]. - Future funding requirements may necessitate raising additional funds through debt or equity securities, which could dilute existing stockholders' ownership[365]. - The company believes existing cash and anticipated net proceeds from the Private Placement will support operations for the next twelve months[366]. - The company’s future funding needs will depend on various factors, including revenue growth, R&D efforts, and the ability to raise additional funds[374]. - The PIPE Investors committed financing valued at $64.5 million as part of the 2024 PIPE Financing, which included a cash investment of $15.9 million by the Perceptive PIPE Investor[317][318]. - Legacy Adagio issued a total of $29.5 million in convertible promissory notes, which were converted into 4,372,607 shares of common stock and 3,540,000 Base Warrants as part of the 2024 PIPE Financing[388]. Research and Development - The company completed enrollment in the FULCRUM-VT IDE pivotal clinical trial with 209 patients across 19 centers in the U.S. and Canada[299]. - The preliminary results of the FULCRUM-VT trial indicated an acute clinical success rate of 97.4% and a major adverse event rate of 2.5%[299]. - Research and development expenditures are expected to increase as the company invests in growth strategies and new product development[323][333]. - Research and development expenses were $2.8 million for the three months ended September 30, 2025, an increase of $0.3 million, or 12.4%, driven by higher clinical trial costs[347]. - Research and development expenses for the nine months ended September 30, 2025, were $8.4 million, a decrease of $0.4 million, or 4.5%[348]. Product Development and Regulatory - The vCLAS Cryoablation System received Breakthrough Device Designation from the FDA in April 2025[296]. - The company plans to submit results from the FULCRUM-VT trial to the FDA in the first half of 2026[299]. - The next-generation ULTC catheter is currently in the design phase, aiming to improve usability and integration with existing workflows[300]. Operational Expenses - Selling, general, and administrative expenses are expected to decrease slightly for the full year 2025 compared to 2024, primarily due to lower payroll and personnel expenses[335]. - Selling, general and administrative expenses decreased by $4.9 million, or 62.5%, to $2.9 million for the three months ended September 30, 2025, primarily due to lower headcount[351]. - For the nine months ended September 30, 2025, selling, general and administrative expenses were $8.9 million, a decrease of $7.1 million, or 44.3%, compared to prior periods, also attributed to reduced payroll expenses[352]. - The company anticipates an increase in selling, general, and administrative expenses in future periods as operations expand[335]. Competition and Market - The company faces intense competition from large, well-capitalized companies and must continue to innovate to maintain market share[328]. - The ability to commercialize products depends significantly on reimbursement from third-party payors, including governmental and private insurers[329]. - Revenue is primarily generated from the sale of catheters used with consoles, with fluctuations due to foreign currency[330]. - Cost of revenue includes raw materials, direct labor, and manufacturing overhead, impacting overall profitability[331]. Miscellaneous - The company is classified as an emerging growth company and a smaller reporting company, with total annual gross revenue of less than $100 million[409]. - The company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[411]. - The company has received an exception from compliance with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act[412]. - The company has reduced disclosure about executive compensation arrangements in periodic reports and proxy statements[412]. - The company is exempt from holding non-binding advisory votes on executive compensation or golden parachute arrangements[412]. - The company is exempt from compliance with requirements regarding the communication of critical audit matters in the auditor's report on financial statements[412].
Adagio Medical Holdings, Inc.(ADGM) - 2025 Q3 - Quarterly Report