Financial Performance - Net sales for the three months ended September 30, 2025, were $0.4 million, a decrease of 44% from $0.8 million in the same period of the prior year; for the nine months, net sales were $1.6 million, down 26% from $2.2 million[130]. - Cost of products sold for the three months ended September 30, 2025, was $0.1 million, a decrease of 72% from $0.4 million in the prior year; for the nine months, it was $0.5 million, down 61% from $1.2 million[131]. - R&D expenses for the three months ended September 30, 2025, were $16.8 million, an increase of 21% from $13.9 million in the prior year; for the nine months, R&D expenses were $49.6 million, up 30% from $38.1 million[132][133]. - Selling, general and administrative expenses for the three months ended September 30, 2025, were $5.8 million, a decrease of 17% from $7.0 million in the prior year; for the nine months, these expenses were $16.4 million, down 16% from $19.7 million[134][135]. - Net foreign exchange losses for the three months ended September 30, 2025, were $0.1 million, a decrease of 94% from $1.3 million in the prior year; for the nine months, losses were $0.6 million, an increase of 34% from $0.5 million[136][137]. - Net cash used in operating activities during the nine months ended September 30, 2025, was $59.3 million, an increase of 38% from $43.0 million in the prior year[144]. - Net cash used in investing activities during the nine months ended September 30, 2025, was $0.2 million, a decrease of 90% from $1.9 million in the prior year[145]. - Net cash used in financing activities during the nine months ended September 30, 2025, was $1.8 million, a decrease of 105% from net cash inflows of $34.4 million in the prior year[146]. - As of September 30, 2025, the company had cash, cash equivalents, and restricted cash of $9.1 million, down from $70.5 million as of December 31, 2024[139]. - The company anticipates requiring additional funds to achieve long-term goals, including completing R&D and commercialization of current products[141]. Regulatory and Clinical Developments - The company has advanced regulatory activities in Europe, securing the first regulatory clearance in Denmark for the PARADIGM Trial, which commenced patient enrollment in October 2025[105]. - The PARADIGM Trial aims to provide primary clinical evidence for FDA Premarket Approval (PMA) of the DurAVR THV System, with a primary endpoint focused on all-cause mortality and cardiovascular hospitalization at one year post-procedure[106][107]. - As of September 2025, a total of 130 patients have been treated with the DurAVR THV worldwide, marking significant progress in clinical application[103]. Operational and Infrastructure Updates - The company is expanding its global manufacturing capacity to support the PARADIGM Trial, transitioning to new ISO Qualified Clean Room facilities to ensure reliable inventory supply[118]. - The company’s operational infrastructure is being strengthened to support upcoming clinical activities and future ISO 13485 certification, mitigating audit risks[108]. - The Transition Services Agreement with LeMaitre expired in January 2025, and the company does not expect ongoing revenues from this source[114]. Financial Commitments and Agreements - The company has commitments to purchase $0.3 million of plant and equipment as of September 30, 2025[150]. - A new 5-year lease agreement was entered into for a facility, resulting in a right-of-use asset and lease liability of $1.6 million[149]. - The company has the option to extend the lease of its Maple Grove facility for an additional two years[149]. Company Classification and Accounting - The company is classified as an "emerging growth company" under the JOBS Act, allowing for an extended transition period for new accounting standards[158]. - The company is also a "smaller reporting company," which allows for scaled disclosures and the presentation of only two years of audited financial statements[160]. - There were no significant changes to accounting policies during the nine months ended September 30, 2025[154]. - The company does not have any off-balance sheet arrangements[151]. - Management continually evaluates judgments and estimates related to financial statements, which could differ from actual results due to risks and uncertainties[153]. - The company has not adopted any new accounting standards yet, as indicated in the quarterly report[157]. Funding and Financial Health - The company has incurred losses since inception and anticipates continued losses, raising concerns about its ability to maintain operations without securing additional funding[109][120]. - The company generated approximately $25.2 million in gross proceeds from a private placement of Common Stock and CDIs in October and November 2025[111][122]. - Research and development (R&D) expenses are expected to increase as the company focuses on the commercialization of the DurAVR THV System, which includes various components like the ComASUR delivery system[110][117]. - The company consolidates v2vmedtech, inc. as a variable interest entity (VIE) and is the primary beneficiary due to control over significant activities and board positions[156].
Anteris Technologies Global Corp(AVR) - 2025 Q3 - Quarterly Report