MCRB — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-05

• On April 21, 2025, we effected a 1-for-20 reverse stock split of our common stock. All shares of our common stock, stock-based instruments, and per-share data included in this Quarterly Report on Form 10-Q have been retroactively adjusted as though the reverse stock split had been effected prior to …

• We are a clinical-stage company focused on improving patient outcomes in medically compromised populations, including oncology patients and those suffering from inflammatory and immune, or I&I, diseases through discovery and development of novel live biotherapeutic product, or LBP, candidates. We le…

• We are designing LBP candidates to modulate host function to protect and improve mucosal epithelial barrier integrity, induce immune homeostasis and tolerance, and prevent the colonization and overgrowth of pathogens in the gastrointestinal, or GI, tract. We believe that the scientific and clinical …

• In the context of preventing infection for patients undergoing allo-HCT for hematological cancer, we believe that our technology may be replicable across different bacterial pathogens with the potential to develop live biotherapeutics to protect a range of medically compromised patients at risk of a…

• We are also evaluating SER-155 in 15 patients with moderate-to-severe (Grade 2- 3) immune checkpoint-related enterocolitis, or irEC, through an investigator-sponsored trial, or IST, with Memorial Sloan Kettering Cancer Center, an institution with whom we have had a decade-long collaboration. irEC is…

Text removed 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 added vs the prior filing · source: 10-Q · 2026-08-05

• invest in our early-stage pipeline product candidates, including SER-603 in IBD and SER-155 in irEC;

• conduct clinical trials for SER-155 in allo-HCT and for other medically vulnerable populations;

• Furthermore, our product candidates may not receive marketing approval even if they achieve their specified endpoints in clinical trials. Clinical data are often susceptible to varying interpretations and many companies that have believed that their products performed satisfactorily in clinical tria…

• submission of the sections of the BLA, the FDA agrees to accept sections of the BLA and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the application.

• work, must continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production and quality control.

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

• the total amount of the Milestone Payments we may receive from the Transaction;

• candidates, or other drugs or biologics. We expect to continue to incur significant expenses and operating losses for the foreseeable future. Our expenses may increase substantially in connection with our ongoing and future activities, particularly if and as we:

• invest in our early-stage pipeline product candidates, including SER-603 in IBD and SER-155 in irEC

• conduct clinical trials for SER-155 in allo-HSCT and for other medically vulnerable populations;

• The total amount of the Milestone Payments we may receive from the Transaction is subject to various risks and uncertainties.