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 approximately 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 worsening 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] - For the nine months ended September 30, 2023, the net loss was $13,880,000, with cash used in operating activities totaling $10,429,000[16] - The company recognized a net loss from discontinued operations of $8.098 million for the nine months ended September 30, 2023, with total revenues of $501,000 during the same period[47] Expenses and Costs - Research and development expenses for the nine months ended September 30, 2024, were $5,395,000, an increase of 42.8% from $3,777,000 for the same period in 2023[13] - Total operating costs and expenses for the three months ended September 30, 2024, were $3,749,000, 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] 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 and Financing Activities - The company had cash and cash equivalents of $11,117,000 at the end of the reporting period, down from $20,275,000 at the beginning of the period[16] - The company raised $8,924,000 from a private placement offering in July 2023, contributing to net cash provided by financing activities of $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 $6.0 million upfront, with an additional $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