Financial Performance - For the three months ended September 30, 2025, the company reported a net loss of $6,482, compared to a net loss of $5,960 for the same period in 2024, and for the nine months ended September 30, 2025, the net loss was $17,170, compared to $16,177 in 2024[144]. - The company has an accumulated deficit of $305,659 as of September 30, 2025, up from $284,734 as of December 31, 2024[144]. - Net revenues for the three months ended September 30, 2025, were $42,000, a decrease of $14,000 or 25.0% compared to the same period in 2024[186]. - Net revenues decreased by $17, or 9.3%, for the nine months ended September 30, 2025, compared to the same period in 2024[198]. - Total costs and operating expenses increased by $1,161, or 7.8%, leading to an operating loss of $15,885 for the nine months ended September 30, 2025[197]. - The operating loss for the three months ended September 30, 2025, was $5,708,000, an increase of $736,000 or 14.8% compared to the same period in 2024[186]. - Cash used in operating activities was $12,516 for the nine months ended September 30, 2025, primarily funding a net loss of $17,170[213]. - As of September 30, 2025, the company had $3,556 in cash, down from $5,483 at the end of 2024[209]. Research and Development - The FDA granted the Investigational Device Exemption (IDE) for the Acclaim CI in October 2024, allowing the company to begin a pivotal clinical study[140]. - The first stage of the clinical trial for the Acclaim CI involved 10 participants, with no serious adverse events reported, leading to FDA approval for the second stage on October 3, 2025[147]. - The second stage of the clinical trial will enroll an additional 46 participants, with the first three patients already enrolled as of October 31, 2025[148]. - The company anticipates submitting a Premarket Approval (PMA) application to the FDA after completing the clinical trial, with a potential decision expected in the second half of 2027[142]. - The company expects R&D expenses to continue increasing as it initiates clinical trials for the Acclaim CI product[175]. - R&D expenses for the nine months increased by $225 to $7,933, with personnel costs up 5.2% and other R&D costs up 107.2%[200]. Expenses and Costs - Cost of goods sold increased by $16,000 to $203,000 for the three months ended September 30, 2025, primarily due to increased material waste during production[188]. - Research and development expenses for the three months ended September 30, 2025, were $2,700,000, a slight decrease of $57,000 or 2.1% compared to 2024[186]. - General and administrative expenses rose by $752,000 or 44.5% to $2,442,000 for the three months ended September 30, 2025[186]. - Sales and marketing expenses increased by $11, primarily due to increased headcount-related expenses, despite a reduction in legal fees of $112[190]. - General and administrative expenses rose by $752, driven by public company costs and expenses related to the September 2025 Offering[191]. - Interest expense related to party loans increased by $1,158, or 268.1%, due to additional issuances of Term Loans[207]. Financing Activities - The company entered into a Securities Purchase Agreement on September 22, 2025, to issue 1,908,402 shares of Common Stock at a price of $1.31 per share[154]. - The September 2025 Offering closed on September 23, 2025, resulting in aggregate gross proceeds of $2,500,000, with potential additional proceeds of $7,500,000 if warrants are fully exercised[156]. - The October 2025 Offering closed on October 9, 2025, generating aggregate gross proceeds of $4,000,000, with potential additional proceeds of $12,000,000 from warrant exercises[160]. - Net cash provided by financing activities for the nine months ended September 30, 2025 was $10,593, driven by proceeds from the issuance of Term Loans of $10,000 and a September 2025 Offering of $2,500[217]. - Net cash provided by financing activities for the nine months ended September 30, 2024 was $14,581, primarily from $15,000 proceeds from the 2024 Term Loans[218]. Compliance and Regulatory Issues - The company received a deficiency notification from Nasdaq regarding non-compliance with the market value listing requirement, with a grace period until February 23, 2026, to regain compliance[149][152]. - The company is targeting FDA approval for the Acclaim CI in the second half of 2027 or first half of 2028[166]. Market Conditions - Macroeconomic conditions, including global conflicts and inflation, have impacted the company's financial performance and capital raising ability[162]. - Inflationary factors may adversely affect operating results, with potential impacts on gross margin if selling prices do not increase accordingly[237]. Other Financial Information - The gain from the change in the fair value of the forward purchase agreement warrant liability was $64, a significant improvement from a loss of $311 in the prior year[192]. - The fair value of the forward purchase agreement warrant liability was estimated at $12 as of September 30, 2025, reflecting a change in fair value of $(522)[224]. - The company has not experienced any material differences between accrued costs and actual costs incurred since inception[227]. - The company has not experienced any losses on accounts receivable and does not believe it is exposed to unusual credit risk[235]. - There were no customers accounting for 10% or more of sales for the three and nine months ended September 30, 2025 and 2024[236].
ANZU SPECIAL(ANZU) - 2025 Q3 - Quarterly Report