Financial Performance - For the three months ended June 30, 2025, the company reported a net loss of $5.7 million, compared to a net loss of $3.9 million for the same period in 2024, and for the six months ended June 30, 2025, the net loss was $10.7 million, compared to $10.2 million in 2024[122]. - The company has an accumulated deficit of $297.9 million as of June 30, 2025, up from $284.7 million as of December 31, 2024[122]. - The company expects to continue incurring net losses and increasing expenses related to research and development, sales and marketing, and general administrative costs[122]. - Net loss for the three months ended June 30, 2025, was $5,690 thousand, a 38.6% increase compared to the same period in 2024[147]. - For the six months ended June 30, 2025, net revenues decreased by $3 thousand, or 2.4%, compared to the same period in 2024[158]. - The company incurred a net loss of $10.7 million for the six months ended June 30, 2025, adjusted for non-cash expenses[172]. Revenue and Sales - Revenue is currently derived primarily from the sale of the Esteem FI-AMEI implants, with new implantations expected to be minimal, potentially as low as zero per year[129]. - Upon commercialization of the Acclaim CI, the company expects revenues to exceed those from the Esteem FI-AMEI[130]. - Net revenues increased by $10 thousand for the three months ended June 30, 2025, representing a 14.7% increase compared to the same period in 2024[147]. Research and Development - The Acclaim CI, the company's lead product candidate, is designed to address severe to profound sensorineural hearing loss and received FDA Breakthrough Device Designation in 2019[111]. - The Investigational Device Exemption (IDE) for the Acclaim CI was granted by the FDA in October 2024, allowing for a pivotal clinical study with an initial enrollment of 10 participants[116]. - The company anticipates submitting a Premarket Approval (PMA) application to the FDA after collecting data from all 56 study participants, with a target FDA decision expected in the second half of 2027 or first half of 2028[119]. - R&D product costs decreased by $473 thousand, while personnel costs increased by $254 thousand, indicating a shift from development to clinical trials[150]. - R&D expenses increased by $0.3 million to $5.233 million for the six months ended June 30, 2025, compared to $4.951 million in 2024, with personnel costs rising by 26.7%[160]. Expenses - Sales and marketing expenses decreased by $136 thousand, or 27.4%, to $361 thousand for the three months ended June 30, 2025[147]. - General and administrative expenses increased by $481 thousand, or 30.3%, to $2,068 thousand for the three months ended June 30, 2025, primarily due to a severance accrual[147]. - Sales and marketing expenses decreased by $0.1 million to $0.9 million for the six months ended June 30, 2025, primarily due to a reduction in legal and professional fees[161]. - General and administrative expenses increased by $0.2 million to $2.2 million for the six months ended June 30, 2025, mainly due to a severance accrual for the former CFO[162]. Cash Flow and Financing - Net cash used in operating activities was $8.185 million for the six months ended June 30, 2025, compared to $10.235 million in 2024, reflecting a decrease in net loss[171]. - Net cash provided by financing activities was $7.992 million for the six months ended June 30, 2025, primarily from Term Loans of $10.0 million[177]. - The company had $5.3 million in cash as of June 30, 2025, down from $5.5 million at the end of 2024[168]. - The company expects to have sufficient funds for operations through September 2025, assuming no additional funding[170]. Economic and Market Conditions - Macroeconomic conditions, including global conflicts and inflation, have impacted the company's financial performance and ability to raise capital[125]. - Inflationary factors may adversely affect operating results, although the company does not believe inflation has materially impacted its financial position to date[197]. Accounting and Financial Management - The company has elected not to opt out of the extended transition period under the JOBS Act, allowing it to adopt new accounting standards at the same time as private companies[192]. - The company maintains cash with high credit quality financial institutions and has not experienced losses on such accounts[195]. - The company performs credit evaluations of customers and does not require collateral, with no material losses reported on accounts receivable[196]. - There have been no material losses on accounts receivable, with no customers accounting for 10% or more of sales for the periods ended June 30, 2025, and 2024[196]. - The change in fair value of the forward purchase agreement warrant liability resulted in a gain of $0.5 million for the six months ended June 30, 2025, compared to a loss of $18 thousand in 2024[164]. Clinical Trials and Warranty - The company estimates clinical trial expenses based on patient enrollment and related costs, adjusting accrued liabilities as actual costs become known[188]. - A lifetime warranty was offered to clinical trial patients, with an estimated cost per unit of $6,000 and an average battery life of five years[189]. - Stock-based compensation is measured at grant date using the Black-Scholes option model, with fair value recognized over the requisite service period[190].
ANZU SPECIAL(ANZU) - 2025 Q2 - Quarterly Report