Nasus Pharma plans to begin a pivotal clinical study of its NS002 intranasal epinephrine powder in Q4 2026, with topline data expected in Q1 2027, positioning the company for a major clinical catalyst in an anaphylaxis market it estimates at approximately $2 billion and currently dominated by injectable products.
The pivotal program follows a completed Phase 2 single- and repeat-dose study. Nasus said the trial produced statistically significant improvements in time to therapeutic epinephrine threshold and a higher proportion of participants reaching therapeutic levels within the first minutes after dosing compared with EpiPen.
NS002 also demonstrated consistent absorption under conditions that included a nasal allergic challenge intended to simulate real-world circumstances that could occur during an anaphylactic reaction. The Q4 pivotal-study timeline remains subject to regulatory alignment.
Nasus is developing NS002 as a needle-free powder formulation of epinephrine for Type I allergic reactions, including anaphylaxis. A successful pivotal program could move the asset closer to competing in a market where emergency treatment has historically centered on injectable epinephrine devices.
The company’s second clinical program is NS003, a proprietary intranasal powder formulation of ondansetron for chemotherapy-induced and postoperative nausea and vomiting. Following favorable preclinical pharmacokinetic results, Nasus plans to begin a first-in-human PK study.
Nasus strengthened its balance sheet ahead of those studies through a private placement of ordinary shares and warrants that generated approximately $15 million of gross proceeds. Cash, equivalents and short-term deposits increased to $11.9 million at June 30 from $4.3 million at the end of 2025, and management expects those resources to fund operations through Q2 2027.
The investment in clinical development is already visible in expenses. First-half R&D spending increased to $2.6 million from $300,000, primarily from NS002 development, while G&A increased to $3.4 million from $500,000 in part because of costs associated with becoming a public company. Net loss widened to $5.9 million from $1.3 million.
Nasus also appointed Brendan O’Grady as CEO effective July 27. He brings more than three decades of pharmaceutical experience spanning commercialization, market access, partnerships, product launches, corporate strategy and business development as the company moves NS002 toward pivotal development and begins pre-commercial planning.
KEY QUOTES:
“Nasus has made enormous progress in its clinical programs in the first six months of 2026, and we believe it is well positioned to advance to NS002 and NS003 toward key milestones in the second half of the year. Building on the positive topline Phase 2 results for NS002 intranasal epinephrine powder formulation, we are on track to initiate a pivotal study in the treatment of anaphylaxis in the fourth quarter of this year, with a topline data readout anticipated in the first quarter of 2027. NS002 represents an opportunity to address a significant unmet medical need in a growing $2 billion market opportunity currently dominated by injectables. While this clinical program advances toward important inflection points, we are also developing the commercial strategy and go-to-market plans designed to deliver the significant value generation that NS002 represents. NS003, our proprietary intranasal powder formulation of ondansetron that is being developed for chemotherapy induced and post-operative nausea and vomiting, demonstrated a favorable safety profile in a preclinical study, and we are preparing to initiate a first-in-human pharmacokinetic study in the coming weeks. We look forward to executing on our timelines over the second half of 2026, and to delivering on the therapeutic promise of our portfolio to patients in need.”
Brendan O’Grady, Chief Executive Officer of Nasus Pharma
