Ernexa Advances ERNA-101 Toward Q3 2026 IND, Backed by $10.5 M Financing
Preclinical studies of ERNA-101 demonstrated high rates of complete tumor regressions and extended survival when combined with PD-1 blockade in an aggressive ovarian cancer model. Ernexa plans an IND submission in Q3 2026 and a first-in-human Phase 1 study in Q4 2026, backed by a $10.5 million financing.
1. ERNA-101 Preclinical Efficacy
ERNA-101 demonstrated high complete tumor regression rates and significantly extended survival when combined with PD-1 blockade in a syngeneic ovarian cancer model, converting immunologically cold tumors into immune-responsive lesions in preclinical studies.
2. Clinical Milestones Roadmap
An IND submission for ERNA-101 is slated for Q3 2026, followed by initiation of a first-in-human Phase 1 trial in Q4 2026, with initial clinical data expected in H1 2027 and progression to Phase 2 in H2 2027.
3. Financial and Operational Progress
Ernexa secured $10.5 million in financing and cut general and administrative expenses by 61% year-over-year in 2025, funding key process development and IND-enabling studies for ERNA-101.
4. ERNA-201 Autoimmune Program
In parallel, development of ERNA-201, an anti-inflammatory iMSC therapy delivering IL-10 to inflamed tissues, is progressing toward a pre-IND meeting expected in Q4 2026 for autoimmune indications.