Sequoia Vaccines ^{Filed Terms, NYSE American: SQVI}

We are a clinical stage pharmaceutical company developing a vaccine designed to prevent recurrent urinary tract infections (UTIs) and small molecules for treating cancers and bacterial infections. Our lead clinical candidate, SEQ-400, is a vaccine under investigation for the prevention of recurrent UTIs, which received fast track designation by the Food and Drug Administration (FDA) in December 2017. We are planning a UTI observation trial in 2023 which will seek to identify and define a population of patients with culture-verified recurrent UTIs to participate in a subsequent phase 2 efficacy trial of SEQ-400 where enrolled patients will serve as their own control comparing UTI occurrences pre and post vaccination with SEQ-400. SEQ-400 is designed to generate antibodies that function to reduce the bacterial attachment and colonization of human bladders to prevent UTIs. We successfully completed a phase 1 study which studied the tolerance and immunogenicity of the adjuvanted vaccine in a population of healthy volunteers and women with a history of recurrent UTIs. This study established a recommended phase 2 dose and schedule. The next step in SEQ-400’s development is to conduct a phase 2 clinical trial to evaluate efficacy in a defined population of patients with culture-verified recurrent UTIs.