Recent Phase 2 topline results demonstrate NS002’s potential for best-in-class epinephrine delivery, with statistically significant improvements in early absorption compared to EpiPen®; pivotal study planned for Q4 2026
Company advancing pipeline assets NS003 (Ondansetron for chemotherapy-induced nausea and vomiting) and NS004 (metabolic) toward first-in-human studies expected to start in the second half of 2026, significantly expanding the Company’s intranasal product portfolio into additional high value therapeutic areas
Company well funded through planned NS002 pivotal study and potential NDA submission
"With positive Phase 2 data for NS002 and a strong cash position, we believe Nasus is well positioned to deliver on multiple clinical inflection points in 2026," said Dan Teleman, Chief Executive Officer of Nasus Pharma. "Following the compelling topline Phase 2 results of NS002, we are advancing our intranasal epinephrine powder formulation towards a pivotal study planned to initiate in the fourth quarter of this year. The Company is well-funded to complete NS002’s pivotal study and see through a potential NDA filing. In addition, we plan to progress our earlier pipeline assets, Ondansetron for chemotherapy induced nausea and vomiting, and NS004 targeting metabolic disorders, into first-in-human studies in the second half of the year and are also advancing NS005 targeting cardiovascular diseases. We believe our pipeline of innovative intranasal products, leveraging our proprietary powder platform technology, can deliver significant clinical benefits to patients and could unlock substantial value to our shareholders. We are committed to executing on this vision.”
Business Update
NS002 – Intranasal powder Epinephrine for Anaphylaxis
- Completed Phase 2 single and repeat dose clinical study, with topline results demonstrating statistically significant improvements in time to therapeutic threshold (T100) and a higher proportion of participants reaching therapeutic epinephrine levels within the first minutes following administration, compared to EpiPen®. The data also demonstrated NS002’s consistent absorption across real-world conditions, including under a nasal allergic challenge designed to simulate anaphylaxis scenarios.
- Advancing toward pivotal development, with a pivotal clinical study expected to initiate in the fourth quarter of 2026 and a planned readout in the first quarter of 2027, subject to regulatory alignment. The Company believes the positive Phase 2 results support continued development toward a potential NDA submission.
Early Pipeline
Nasus is advancing its earlier-stage pipeline programs, which leverage the Company’s proprietary intranasal powder platform:
- NS003 – Ondansetron for chemotherapy-induced nausea and vomiting
- NS004 – targeting metabolic disorders
- NS005 – targeting cardiovascular diseases
All programs are currently in preclinical development, with first-in-human Phase 1 studies expected to initiate in the second half of 2026 for NS003 and NS004, supporting the continued expansion of the Company’s intranasal product portfolio.
Financial Results
Cash,
Research and Development Expenses: Research and development expenses were
General and Administrative Expenses: General and administrative expenses were
Net Loss: For the year ended
The Company has filed its Annual Report on Form 20-F for the year ended
About Nasus Pharma
Nasus Pharma is a clinical-stage pharmaceutical company developing a number of intranasal powder products addressing acute medical conditions in the community. NS002, Nasus Pharma’s intranasal powder Epinephrine product candidate is being developed as a needle-free alternative to Epinephrine autoinjectors for patients with anaphylaxis. Intranasal administration is most suitable for those situations in which rapid drug delivery is required and offers needle-free, easy-to-use alternatives. Nasus Pharma’s proprietary powder-based intranasal (“PBI”) technology is designed for rapid and reliable drug delivery, leveraging the nasal cavity’s rich vascular network for quick absorption. The PBI formulation uses uniform spherical powder particles for broad dispersion and potentially faster, higher absorption compared to liquid-based nasal products. For further information about the Company, please visit www.nasuspharma.com or follow on Twitter (X) or LinkedIn.
Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and other
Company Contact
info@nasuspharma.com
Investor Contact
+1-617-308-4306
mmoyer@lifesciadvisors.com
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