“We are in active discussions with multiple parties seeking capital and other resources to support further development of SER-155 for the prevention of BSIs and our broader portfolio of live biotherapeutic product candidates with applications for inflammatory diseases. The types of transactions we are evaluating include partnerships, out-licensing deals, mergers, and other structures to access capital, and aim to leverage Seres’ expertise and track record of successfully bringing a live biotherapeutic product to the market,” said Thomas DesRosier and Marella Thorell, co-CEOs of Seres. “Our clinical data underscore the potential of SER-155 to transform care for allo-HSCT recipients and other high-risk patients vulnerable to bloodstream infections, an area of significant unmet need and commercial opportunity. Informed by constructive FDA feedback, we have submitted a protocol to the agency for a well-powered, placebo-controlled SER-155 Phase 2 study, which includes a planned interim analysis designed to enable an expedited readout. The FDA has continued to engage with the Company and has indicated they will provide feedback, which we expect will support finalizing the protocol.”
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