Company Description

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 2024 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. Lead Clinical Candidate SEQ-400, Vaccine for the prevention of recurrent UTIs 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. The phase 1 study included 67 women, including 25 women with a two-year documented history of recurrent UTIs. These women had fewer recurrent UTIs after achieving peak antibody responses produced by the vaccine as compared to the 9-month time period preceding peak antibody response. The antibodies generated in these women were evaluated in laboratory studies and were shown to reduce the adherence of bacteria to human bladder cells, which is the intended mechanism of action of the vaccine. Furthermore, patients in the phase 1 study reported very few local (injection site swelling, tenderness, burning, redness) adverse reactions and systemic (headaches, nausea, fatigue) adverse reactions and no severe systemic adverse reactions. Local and systemic adverse reactions generally resolved within seven days. Therefore, we believe SEQ-400 is well positioned to begin a phase 2 trial designed to evaluate efficacy and safety in a larger population of patients with recurrent UTIs. The phase 1 study for SEQ-400 was an open-label, uncontrolled, dose escalation study conducted at six clinical sites in Maryland, Michigan, North Carolina, South Carolina, and Utah. In accordance with the phase 1 study’s protocol, patient participation in the study was 19 months, which included 30 days before the first vaccination and 18 months following the first vaccination. The objectives of the phase 1 study were to evaluate the safety and immunogenicity of the SEQ-400. The study included 67 females, ages 21-64, in 7 cohorts. Subjects received four doses of vaccine at Day 1, Day 30, Day 90 and Day 180. A safety review committee allowed enrollment of subsequent cohorts after review of safety assessments. Subjects in cohorts 1 to 5 did not have a history of UTIs in the previous 24 months prior to enrollment into the study. Subjects in cohorts 6 and 7 had 5 or more documented UTIs in the last 24 months, including at least 1 UTI with a urine culture identifying E. coli. For subjects in cohorts 6 and 7, UTI symptoms were recorded during the study per protocol. Of the 67 enrolled subjects, 57 received all four vaccinations. In cohorts 6 and 7, 30 subjects with recurrent UTIs were enrolled; 26 received all four vaccinations and 25 completed the 19-month study. These women were 25 to 64 years of age. The 30 women who were enrolled experienced more than 180 UTIs in the 24 months preceding enrollment. Their medical record documentation included more than 80 antibiotic susceptibility reports for E. coli identified from clean-catch midstream urine collections. These susceptibility data demonstrated that 15 women each had at least one UTI with E. coli resistant to trimethoprim-sulfamethoxazole, and 14 women each had at least one UTI with E. coli resistant to ciprofloxacin. Despite antibiotic refills being listed in these records, the use of these refills was not investigated or tabulated, so it is probable that some of these 30 women had additional undocumented UTIs in the preceding 24 months. Fourteen of the subjects had been prescribed antibiotic prophylaxis at least once in the previous 24 months. --- We were incorporated under the laws of the State of Delaware on August 16, 2012. On April 30, 2021, we undertook a combination transaction (“Combination Transaction”) to combine the businesses, assets and liabilities of Sequoia Sciences, Inc. (“SSI”) and Sequoia Sciences UTI, LLC (“SSUTI”) with and into us. For certain periods prior to the Combination Transaction, we were a consolidated subsidiary of SSUTI. We are the surviving entity of the Combination Transaction. The merger with SSI (the “SSI Merger”) was accounted for as an asset acquisition by us. The merger with SSUTI (the “SSUTI Merger”) reflects a transaction between entities under common control and was accounted for as a downstream merger, with the transferred assets and liabilities recorded at their historical cost basis. Our principal executive office is located at 1912 Innerbelt Business Center Drive, St. Louis, MO 63114 and our telephone number is (314) 373-5181. Our website is www.sequoiavaccines.com.