Pieris Pharmaceuticals(PIRS) - 2024 Q4 - Annual Results

Financial Performance - The net loss for the year ended December 31, 2024, was $17.4 million, or $7.83 per share, compared to a net income of $17.9 million, or $2.19 per share, for the previous year[13]. - Net loss for 2024 was $17,434,000 compared to a net income of $17,915,000 in 2023, representing a shift of 197.4%[22]. - Total operating expenses for 2024 were $14,095,000, an increase of 18.5% from $11,869,000 in 2023[22]. Cash and Assets - As of December 31, 2024, cash and cash equivalents were $83.6 million, expected to fund operations into the second half of 2027[2][13]. - Cash and cash equivalents increased dramatically to $83,602,000 in 2024 from $7,350,000 in 2023, a growth of 1030.5%[23]. - Total current assets rose to $88,234,000 in 2024, up from $7,548,000 in 2023, an increase of 1066.5%[23]. - Current liabilities increased to $12,038,000 in 2024 from $2,360,000 in 2023, a rise of 410.3%[23]. - Total liabilities grew to $25,627,000 in 2024, compared to $11,428,000 in 2023, an increase of 124.7%[23]. - Total stockholders' equity improved to $62,607,000 in 2024 from a deficit of $74,483,000 in 2023[23]. Research and Development - Research and development expenses for the year ended December 31, 2024, were $8.2 million, a decrease from $8.8 million in 2023[13]. - Research and development expenses decreased to $8,151,000 in 2024 from $8,793,000 in 2023, a reduction of 7.3%[22]. General and Administrative Expenses - General and administrative expenses increased to $5.9 million for the year ended December 31, 2024, compared to $3.1 million in 2023, primarily due to costs associated with becoming a public company[13]. - General and administrative expenses rose significantly to $5,944,000 in 2024, up 93.5% from $3,076,000 in 2023[22]. Clinical Studies and Pipeline - The company anticipates top-line results from the Phase 3 SELVA study for QTORIN™ rapamycin in microcystic lymphatic malformations in the first quarter of 2026[1][6]. - Top-line results from the Phase 2 TOIVA study for QTORIN™ rapamycin in cutaneous venous malformations are expected in the fourth quarter of 2025[1][9]. - The company plans to broaden its QTORIN™ pipeline by advancing new and existing programs for additional serious, rare genetic skin diseases in 2025[4][8]. - QTORIN™ rapamycin has received Breakthrough Therapy Designation, Orphan Drug Designation, and Fast Track Designation from the U.S. FDA for the treatment of microcystic lymphatic malformations[6][9]. Mergers and Acquisitions - The merger with Pieris Pharmaceuticals was completed in December 2024, along with a concurrent private placement of $78.9 million[8]. - The company estimates that the combined U.S. peak annual sales for the initial indications of QTORIN™ rapamycin could exceed $1 billion[3].