Financial Performance - Total revenue for the three months ended September 30, 2024, was 370,000 for the same period in 2023, representing a decrease of approximately 68.4%[13] - The net loss for the three months ended September 30, 2024, was 1,357,000 for the same period in 2023, indicating a worsening of 146.5%[13] - Basic and diluted loss per share for continuing operations was (0.08) for the same period in 2023[13] - As of September 30, 2023, the company reported a net loss of 18,307,000[15] - For the nine months ended September 30, 2023, the net loss was 10,429,000[16] - The company recognized a net loss from discontinued operations of 501,000 during the same period[47] Expenses and Costs - Research and development expenses for the nine months ended September 30, 2024, were 3,777,000 for the same period in 2023[13] - Total operating costs and expenses for the three months ended September 30, 2024, were 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 378,000 for the same period in 2023[79] Equity and Liabilities - Total stockholders' equity decreased to 14,105,000 as of December 31, 2023[10] - The accumulated deficit increased to (444,226,000) as of December 31, 2023[10] - The company reported total liabilities and stockholders' equity of 20,395,000 as of December 31, 2023[10] Cash and Financing Activities - The company had cash and cash equivalents of 20,275,000 at the beginning of the period[16] - The company raised 12,044,000 for the nine months ended September 30, 2023[16] - The Company entered into a private placement on January 17, 2024, resulting in aggregate gross proceeds of 10.0 million contingent upon positive clinical trial results for the NEPHRO CRRT study of Niyad[65] - The first tranche of the private placement closed on January 22, 2024, generating approximately $6.0 million for pre-funded warrants to purchase up to 7,792,208 shares of common stock[66] 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 Niyad™, a regional anticoagulant, and LTX-608, a nafamostat formulation, for various medical indications[18][21] - The company completed an asset acquisition agreement for the DSUVIA product on April 3, 2023, which included the transfer of certain assets and liabilities[20] Risks and Concerns - The company faces significant risks including market volatility, supply chain disruptions, and the ability to obtain necessary financing for ongoing 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 recently issued accounting standards but does not expect them to materially affect its consolidated financial statements[36] - Management's significant accounting estimates include fair value of warrants and impairment of long-lived assets, which could differ from actual results[28] - The effective interest rate for the liability related to the sale of future payments will be reassessed at each reporting date[33] Stock and Equity Compensation - 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 granted stock-based awards totaling 217,000 shares to a new employee as an inducement for employment in May 2024[73] - The Company amended its 2011 Employee Stock Purchase Plan to increase the number of authorized shares by 100,000, resulting in a total of 345,000 shares available for issuance[74] - As of September 30, 2024, the total stock options outstanding increased to 1,879,806, with a weighted average remaining contractual life of 7.7 years[81] Litigation - The Company believes ongoing litigation is without merit and intends to defend against it, but cannot estimate potential losses due to the uncertainty of litigation outcomes[64]
Talphera(TLPH) - 2024 Q3 - Quarterly Report