Talphera(TLPH) - 2025 Q3 - Quarterly Results

Financing and Cash Position - Talphera closed a $17 million first tranche financing led by CorMedix, with a total financing goal of up to $29 million[6]. - Cash and investments as of September 30, 2025, were $21.3 million, expected to be sufficient through a potential PMA approval of Niyad in late 2026[1]. - As of September 30, 2025, cash, cash equivalents, and investments increased to $21,289,000 from $8,863,000 as of December 31, 2024, representing a growth of 140.4%[17]. Clinical Studies and Product Development - Five of the nine target clinical study sites for the NEPHRO study are activated, with completion expected in H1 2026[1]. - The NEPHRO CRRT study aims to enroll 70 adult patients and has received central IRB approval[12]. - Talphera's lead product candidate, Niyad, is being studied as an anticoagulant and has received Breakthrough Device Designation from the FDA[9]. Financial Performance - The net loss from continuing operations for Q3 2025 was $4.4 million, compared to a net loss of $3.4 million in Q3 2024[6]. - The company recognized revenue of $1,000 for Q3 2025, compared to $0 for Q3 2024[15]. - Net loss attributable to common shareholders for Q3 2025 was $4.4 million, or $0.11 per share, compared to a net loss of $3.4 million, or $0.13 per share, in Q3 2024[6]. Operating Expenses - Combined R&D and SG&A expenses for Q3 2025 totaled $3.4 million, a decrease from $3.7 million in Q3 2024[6]. - For the three months ended September 30, 2025, total operating expenses were $3,423,000, a decrease of 8.7% from $3,749,000 in the same period of 2024[18]. - Research and development expenses for the three months ended September 30, 2025, were $1,803,000, down from $2,053,000 in 2024, representing a decline of 12.1%[18]. - Selling, general and administrative expenses decreased to $1,620,000 in the three months ended September 30, 2025, from $1,696,000 in 2024, a reduction of 4.5%[18]. - Non-GAAP operating expenses for the nine months ended September 30, 2025, were $9,545,000, down from $11,497,000 in 2024, indicating a decrease of 16.9%[18]. - Stock-based compensation expense for the three months ended September 30, 2025, was $152,000, compared to $234,000 in 2024, a decrease of 35.0%[18]. - The company reported a total operating expenses (non-GAAP) of $3,271,000 for the three months ended September 30, 2025, down from $3,515,000 in 2024, a decline of 6.9%[18]. Balance Sheet Highlights - Total assets rose to $30,742,000 in September 2025, up from $18,236,000 in December 2024, indicating a 68.5% increase[17]. - Total liabilities increased to $11,565,000 in September 2025, compared to $10,235,000 in December 2024, reflecting a rise of 13.0%[17]. - Total stockholders' equity surged to $19,177,000 in September 2025, up from $8,001,000 in December 2024, marking an increase of 139.5%[17].