Sintx Technologies(US:SINT)2025-11-13 13:05Regulatory Approvals - SINTX received FDA 510(k) clearance for the SINAPTIC® Foot & Ankle Osteotomy Wedge System, marking a significant milestone for commercial entry into reconstructive foot and ankle surgery in the U.S.[6] Financial Performance - Total revenue for Q3 2025 was $208 million, a decrease of 74.0% compared to $799 million in Q3 2024[17]. - Product revenue for the nine months ended September 30, 2025, was $541 million, down 48.7% from $1,054 million in the same period of 2024[17]. - Gross profit for Q3 2025 was $93 million, significantly lower than $589 million in Q3 2024, reflecting a gross margin decline[17]. - The net loss for Q3 2025 was $3,539 million, compared to a net loss of $6,239 million in Q3 2024, indicating an improvement[17]. - The company reported a net loss attributable to common stockholders of $10,258 million for Q3 2025, compared to $6,239 million in Q3 2024[17]. - Basic net loss per share for Q3 2025 was $(1.19), compared to $(6.96) in Q3 2024[17]. - Adjusted EBITDA loss was $2.3 million in Q3 2025, a significant improvement from a loss of $6.1 million in Q3 2024[6]. - Adjusted EBITDA for Q3 2025 was $(2,308) million, an improvement from $(6,085) million in Q3 2024[19]. Operating Expenses - Operating expenses decreased by 51% year-over-year to approximately $3.4 million, leading to an operating loss of $3.4 million compared to $6.4 million in Q3 2024[6]. - Total operating expenses for Q3 2025 were $3,448 million, a decrease of 50.7% from $6,997 million in Q3 2024[17]. - Research and development expenses for Q3 2025 were $1,264 million, up 58.7% from $796 million in Q3 2024[17]. Liquidity and Cash Management - Cash and cash equivalents increased to $6.25 million as of September 30, 2025, up from $3.60 million on December 31, 2024, reflecting improved liquidity management[6]. - SINTX raised an additional $4.3 million in gross proceeds through warrant inducement and common stock warrant exercises, strengthening its liquidity position[6]. Asset and Liability Management - Total assets increased to $11.36 million as of September 30, 2025, compared to $9.41 million on December 31, 2024[15]. - Total liabilities rose to $7.30 million as of September 30, 2025, up from $5.52 million on December 31, 2024[15]. Strategic Initiatives - The company plans to prepare the SINAPTIC wedge system for launch and expand clinical engagement in targeted surgical specialties[7]. - The company executed a sublease of the Armor facility, estimated to save approximately $950,000 in lease costs over the sublease term[6]. Shareholder Information - Weighted average common shares outstanding for Q3 2025 were 2,963,539, significantly higher than 896,305 in Q3 2024[17].