SAB Biotherapeutics(US:SABS)2025-11-13 22:43Revenue and Income - No revenue was recognized for the three months ended September 30, 2025, and approximately $1.2 million was recognized from government grants for the nine months ended September 30, 2024[174]. - Total revenue for the nine months ended September 30, 2025, was $0, a decrease of $1.2 million, or 100.0%, compared to $1.2 million in the same period of 2024 due to the JPEO Rapid Response Contract Termination[188][189]. - The company recognized no revenue for the three and nine months ended September 30, 2025, with total revenue for the same periods in 2024 coming entirely from government grants[230]. Research and Development Expenses - Total research and development expenses for the three months ended September 30, 2025, were $8,970,010, an increase from $7,830,745 in the same period of 2024, representing a year-over-year increase of approximately 14.6%[180]. - Clinical trial expenses for the three months ended September 30, 2025, were $3,401,934, compared to $1,462,044 for the same period in 2024, indicating a significant increase of approximately 132.7%[180]. - Total research and development expenses for the nine months ended September 30, 2025, were $23,623,991, compared to $22,599,998 for the same period in 2024, reflecting an increase of approximately 4.5%[180]. - Salaries and benefits for research and development in the three months ended September 30, 2025, amounted to $3,324,307, up from $2,754,884 in 2024, marking an increase of approximately 20.7%[180]. - Research and development expenses increased by $1.1 million, or 14.5%, to $8,970,010 for the three months ended September 30, 2025, compared to $7,830,745 in 2024, driven by higher salaries, animal care, and clinical trial costs[191]. - The company anticipates an increase in research and development expenses in future years as it advances its lead therapeutic candidate through Phase 2 clinical trials[192]. - The company expects to incur substantial research and development expenses as it continues to enhance its platform and work on its indications, with plans to hire additional employees[177]. General and Administrative Expenses - General and administrative expenses rose by $0.2 million, or 6.6%, to $3,708,959 for the three months ended September 30, 2025, compared to $3,478,621 in 2024, primarily due to increased administrative support fees[193]. - General and administrative expenses decreased by $2.0 million, or 16.9%, to $9,559,141 for the nine months ended September 30, 2025, compared to $11,509,394 in 2024, due to reductions in salaries and benefits[194][195]. - The company anticipates that general and administrative expenses will rise as it expands its workforce and prepares for potential commercialization of its lead therapeutic candidate[181]. Non-Operating Income and Interest - Total non-operating income for the three months ended September 30, 2025, increased by $56.8 million, or 7459.3%, to $57,512,497, primarily due to a $61.6 million gain from changes in fair value of warrant liabilities[197]. - Interest income surged by $378,059, or 136.4%, to $655,233 for the three months ended September 30, 2025, compared to $277,174 in 2024, mainly from investments in debt securities[201]. - Interest income decreased by $418,331, or 36.39%, to $731,293 for the nine months ended September 30, 2025, compared to $1,149,624 for the same period in 2024[202]. Cash Flow and Financing - Net cash used in operating activities increased by $3.2 million to $27,998,784 for the nine months ended September 30, 2025, compared to $24,759,821 for the same period in 2024[214]. - Net cash used in investing activities rose by $98.7 million to $119,999,975 for the nine months ended September 30, 2025, primarily due to increased purchases of short-term investments[217]. - Net cash provided by financing activities increased by $169.7 million to $168,341,137 for the nine months ended September 30, 2025, largely due to the Series B Offering[218]. - The Series B Offering generated approximately $175 million in gross proceeds, intended to fund the Phase 2b SAFEGUARD study of SAB-142 and for general corporate purposes[205]. Company Outlook and Financial Position - The company anticipates continued losses and an accumulated deficit of $94.0 million as of September 30, 2025, requiring additional capital for operations and product development[204]. - The company had cash and cash equivalents of $161.5 million as of September 30, 2025, compared to $20.8 million as of December 31, 2024[231]. - The valuation allowance on net deferred tax assets increased by approximately $7.1 million during the nine months ended September 30, 2025, due to current and prior year losses[220]. - The company does not expect to generate revenues during the development phase of its primary pipeline target for Type 1 diabetes, which remains independently financed[190]. Clinical Development - The company received Investigational New Drug (IND) clearance from the FDA for SAB-142 in May 2024 and is advancing into a Phase 2b clinical trial called the SAFEGUARD study[171]. - The company aims to utilize data from the Phase 2b SAFEGUARD study as supportive evidence for future regulatory approval of SAB-142[171]. - The company’s proprietary platform is designed to produce disease-targeted human immunoglobulin G (hIgG) in large quantities without the need for human plasma donors, providing a competitive advantage[168]. Foreign Currency and Risk Management - The company does not currently hedge foreign currency exchange rate risk, and liabilities denominated in foreign currencies were not material as of September 30, 2025[232].