Nasus Pharma Advances NS002 Towards Pivotal Study Following Positive Phase 2; Reports Annual Results and Provides Business Update

Core Insights - Recent Phase 2 topline results indicate NS002's potential for best-in-class epinephrine delivery, showing statistically significant improvements in early absorption compared to EpiPen®; a pivotal study is planned for Q4 2026 [1][6] - The company is advancing pipeline assets NS003 (Ondansetron for chemotherapy-induced nausea and vomiting) and NS004 (metabolic disorders) toward first-in-human studies expected to start in the second half of 2026, expanding its intranasal product portfolio into high-value therapeutic areas [1][4] - The company is well-funded through the planned NS002 pivotal study and potential NDA submission, with cash, cash equivalents, and marketable securities of $4.3 million as of December 31, 2025, up from $0.3 million in 2024 [7] Business Update - NS002 is an intranasal powder formulation of epinephrine for anaphylaxis, demonstrating significant improvements in time to therapeutic threshold (T100) and a higher proportion of participants reaching therapeutic levels quickly compared to EpiPen® [6] - The pivotal clinical study for NS002 is expected to initiate in Q4 2026, with a readout planned for Q1 2027, subject to regulatory alignment [6] - The company is also advancing NS005, targeting cardiovascular diseases, alongside NS003 and NS004 [2][6] Financial Results - Research and development expenses for the year ended December 31, 2025, were $2.4 million, compared to $0.3 million in 2024, primarily due to NS002 development costs [8] - General and administrative expenses increased to $2.7 million in 2025 from $0.7 million in 2024, attributed to the transition to a public company [9] - The net loss for the year ended December 31, 2025, was $5.9 million, compared to a net loss of $1.5 million in 2024, with 9,015,383 shares outstanding as of December 31, 2025 [9]