AcelRx Pharmaceuticals(ACRX) - 2024 Q3 - Quarterly Report

Financial Performance - Total revenue for the three months ended September 30, 2024, was $117,000, compared to $370,000 for the same period in 2023, representing a decrease of 68.4%[13] - The net loss for the three months ended September 30, 2024, was $3,353,000, compared to a net loss of $1,357,000 for the same period in 2023, indicating a deterioration of 146.5%[13] - Basic and diluted loss per share for continuing operations was $(0.13) for the three months ended September 30, 2024, compared to $(0.08) for the same period in 2023[13] - As of September 30, 2023, the company reported a net loss of $1,357,000, with total equity amounting to $18,307,000[15] - The company recognized a net loss from discontinued operations of $8,098 thousand for the nine months ended September 30, 2023, with total revenues from discontinued operations at $501 thousand[47] Expenses and Costs - Research and development expenses for the three months ended September 30, 2024, were $2,053,000, an increase of 74.4% from $1,178,000 in the same period of 2023[13] - Total operating costs and expenses for the three months ended September 30, 2024, were $3,749,000, compared to $3,426,000 for the same period in 2023, reflecting an increase of 9.4%[13] - The Company recorded total stock-based compensation expense of $234,000 for the three months ended September 30, 2024, compared to $378,000 for the same period in 2023[79] - The total stock-based compensation expense for the nine months ended September 30, 2024, was $759,000, down from $1,418,000 for the same period in 2023[79] Equity and Liabilities - Total stockholders' equity decreased to $9,641,000 as of September 30, 2024, down from $14,105,000 as of December 31, 2023[10] - The accumulated deficit increased to $(455,360,000) as of September 30, 2024, compared to $(444,226,000) as of December 31, 2023[10] - The company reported total liabilities and stockholders' equity of $21,014,000 as of September 30, 2024, compared to $20,395,000 as of December 31, 2023[10] Cash Flow and Financing - The company experienced a net cash used in operating activities of $10,429,000 for the nine months ended September 30, 2023, compared to $13,543,000 for the same period in the previous year[16] - The company had cash and cash equivalents of $11,117,000 at the end of the reporting period, down from $13,389,000 at the beginning of the period[16] - The company raised $5,884,000 from the issuance of common stock related to the exercise of prefunded warrants during the reporting period[16] - Management plans to seek additional capital through various means, including public or private equity offerings and potential asset monetization[24] Product Development and Strategy - The company is focused on advancing the development of its lead product candidate, Niyad™, and aims to secure regulatory approval and commercialization[6] - The company is focused on developing innovative therapies, including Niyad™ and LTX-608, targeting conditions such as acute respiratory distress syndrome and disseminated intravascular coagulation[18] - The company has a product development pipeline that includes a license agreement for ephedrine and phenylephrine pre-filled syringes, pending FDA approval[22] Risks and Concerns - The company faces significant risks including market volatility, supply chain disruptions, and the ability to obtain necessary financing for operations[6] - The company has incurred recurring operating losses and negative cash flows since inception, raising concerns about its ability to continue as a going concern[23] - The Company may need to reduce its workforce or delay clinical trials if adequate funds are not available[25] Accounting and Financial Reporting - The Company is evaluating the impact of new accounting standards, including ASU 2023-07 and ASU 2023-09, but does not expect them to materially affect financial statements[34][35] - The Company has reclassified certain prior year amounts in its financial statements to conform to current year presentation[29] - The Company believes its most significant accounting estimates relate to revenue recognition and impairment of long-lived assets[28] Stock and Warrants - As of September 30, 2024, the Company had 29,474,257 warrants outstanding, with a weighted average exercise price of $0.96 per share[75] - The Company amended its 2020 Equity Incentive Plan to increase the number of authorized shares by 1,171,395, bringing the total to 3,161,395 shares[72] - The Company amended its 2011 Employee Stock Purchase Plan to increase the number of authorized shares by 100,000, totaling 345,000 shares[74] - The basic net loss per share of common stock is calculated by dividing the net loss by the weighted average number of shares outstanding for the period[83] - A total of 2,096,052 common stock equivalents were excluded from the computation of diluted net loss per share for the three months ended September 30, 2024, due to antidilutive effects[84]