Azitra Inc(US:AZTR)2024-05-09 21:05Clinical Trials and Development Progress - ATR-12 Phase 1b trial advanced with clinical sites activated and initial Netherton syndrome patients identified for dosing, with primary endpoints focusing on safety and tolerability[2] - ATR-04 pre-IND meeting with FDA successfully completed, with IND submission planned for mid-2024 and Phase 1b trial initiation targeted for late 2024[2][3] - ATR-12 preclinical data presented at ASGCT shows superior LEKTI delivery and significant reduction of IL-36g, a pro-inflammatory cytokine implicated in Netherton syndrome[2][3] Financial and Funding Updates - Follow-on public offering completed in February 2024, raising $5.0 million in gross proceeds to support clinical programs[4] - Q1 2024 R&D expenses increased to $1.5 million compared to $0.8 million in Q1 2023[6] - Q1 2024 net loss was $2.9 million, compared to $2.5 million in Q1 2023[6] - Cash and cash equivalents as of March 31, 2024, totaled $3.0 million[6] Market Potential and Intellectual Property - ATR-12 estimated peak sales opportunity is ~$250 million, targeting a global prevalence of 20,000+ Netherton syndrome patients[4] - ATR-04 estimated peak sales opportunity exceeds $1 billion, targeting a U.S. prevalence of ~150,000 EGFRi-associated rash patients[5] - U.S. patent issued for treating skin diseases, including ichthyosis vulgaris, affecting approximately 1.3 million Americans[4]