MCRB — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-05

• We are a clinical-stage company focused on improving patient outcomes in medically vulnerable populations through discovery and development of novel live biotherapeutic product, or LBP, candidates. We led the successful development and approval of VOWST, the first FDA-approved orally administered mi…

• We are designing LBP candidates to modulate host function to increase epithelium integrity and to induce immune homeostasis and tolerance, as well as to prevent the colonization and overgrowth of pathogens in the gastrointestinal, or GI, tract. We believe that the scientific and clinical data from t…

• SER-155, our most advanced LBP candidate, is an investigational, oral, live biotherapeutic designed to decolonize GI pathogens, improve GI epithelial barrier integrity, and induce immune homeostasis to prevent bacterial BSIs, including those that can harbor antimicrobial resistance, as well as other…

• Our current strategy prioritizes advancing our programs that target I&I indications. We have meaningfully advanced over the past decade our scientific understanding of how microbes in the GI functionally modulate pathways at the mucosal barrier-immune interface that are associated with inflammatory …

• colitis and could broadly address immune therapy toxicities, both of which represent significant unmet medical needs and potential commercial opportunities. We are currently exploring potential collaborations related to those I&I disease programs.

Text removed vs the prior filing · source: 10-Q · 2025-11-05

• We are a clinical-stage company focused on improving patient outcomes in medically vulnerable populations through novel live biotherapeutics. We led the successful development and approval of VOWST, the first FDA-approved orally administered microbiome therapeutic, which was sold to Société des Prod…

• In our placebo-controlled Phase 1b study of SER-155 in allo-HSCT, Cohort 2 results demonstrated that SER-155 was associated with a 77% relative risk reduction in bacterial BSIs and a significant reduction in systemic antibiotic exposure as well as a lower incidence of febrile neutropenia, as compare…

• Based on prior FDA feedback, we are progressing start-up activities for our SER-155 Phase 2 study in allo-HSCT that could provide a time and capital-efficient path to obtaining clinical results. We require additional capital to begin this study. In May 2025, we filed the SER-155 Phase 2 protocol wit…

• Our live biotherapeutic candidates are consortia of bacteria designed to optimize specific, targeted pharmacological properties, and are formulated for oral delivery. We maintain a differentiated live biotherapeutics drug discovery and development platform that includes good manufacturing practices,…

• Our business development discussions are focused on supporting SER-155 clinical advancement to reduce the risk of BSIs, including life-threatening and antimicrobial resistant infections, in medically vulnerable patient populations. We believe that SER-155 and other cultivated live biotherapeutic can…

Text added vs the prior filing · source: 10-Q · 2026-05-05

• We have identified conditions and events that raise substantial doubt regarding our ability to continue as a going concern.

• Based on our currently available cash resources, and considering our future operating plans, we anticipate that we will require additional funding following the third quarter of 2026. The ability to obtain additional equity or other financing, including through partnerships, with terms favorable or …

• We will need additional funding in order to advance development of our product candidates (including to conduct the Phase 2 study of SER-155 in allo-HSCT and to advance our earlier stage programs) and commercialize our product candidates, if approved. If we are unable to raise capital or secure a pa…

• Our expenses may increase in connection with our ongoing activities, particularly if we further SER-155 clinical studies, and research, develop and initiate clinical trials of our product candidates. In addition, if we obtain marketing approval for any of our product candidates, we expect to incur c…

• We are actively seeking a business development transaction, which may include a partnership, to provide financial support and share in our vision to realize the clinical and commercial value of SER-155. Our strategic discussions are focused on supporting SER-155 clinical advancement to reduce the ri…

Text removed vs the prior filing · source: 10-Q · 2025-11-05

• We will need additional funding in order to advance development of our product candidates (including to complete the planned Phase 2 study of SER-155 in allo-HSCT) and commercialize our product candidates, if approved. If we are unable to raise capital or secure a partnership or other business devel…

• Our expenses may increase in connection with our ongoing activities, particularly if and as we further SER-155 clinical studies, and research, develop and initiate clinical trials of our product candidates. In addition, if we obtain marketing approval for any of our product candidates, we expect to …

• We are actively seeking a business development transaction, which may include a partnership, to provide financial support and who shares our vision to realize the clinical and commercial value of SER-155. Our strategic discussions are focused on supporting SER-155 clinical advancement to reduce the …

• the cost of conducting clinical trials for our lead candidate, SER-155 in allo-HSCT and other targeted indications, and other product candidates in our pipeline;

• the total amount of the Milestone Payments we may receive from the Transaction, and the amounts payable or due under the Profit Sharing Payments;