ADDED
As of March 6, 2026 there wer e 9,586,298 shares of the registrant s common stock, par value $0.001 per share, outstanding.
The principal risks and uncertainties affecting our business include the following: We have identified conditions and events that raise substantial doubt regarding our ability to continue as a going concern.
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 commercialize our product candidates, if approved.
If we are unable to raise capital or secure a partnership or other business development transaction, we could be required to implement further cost-reduction measures, reduce or delay our product development programs or any potential future commercialization efforts, or pursue other alternatives, which could include seeking relief under the U.S Bankruptcy Code or winding down our operations.
3 The total amount of the Milestone Payments (as defined herein) we may receive from the Transaction is subject to various risks and uncertainties.
Disruptions at the FDA and other government agencies caused by funding shortages, government shutdowns, or staffing limitations could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business.
Current and future legislation or regulation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and may adversely affect the prices we may obtain.
We have in the past and may again in the future receive a notice of the failure to satisfy a continued listing rule from Nasdaq.
B usiness Overview 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 microbiome biotherapeutic and a Breakthrough Therapy designated drug, which was sold to Soci t des Produits Nestl S.A., or SPN, and with certain of its affiliates, collectively, Nestl Health Science, in September 2024.
REMOVED
As of March 7, 2025 there were 174,358,753 shares of the registrant s common stock, par value $0.001 per share, outstanding.
The principal risks and uncertainties affecting our business include the following: We will need additional funding in order to advance development of our product candidates and commercialize our product candidates, if approved.
If we are unable to raise capital or secure a partnership when needed, we could be forced to delay, reduce or eliminate our product development programs or any potential future commercialization efforts.
We have identified conditions and events that raise substantial doubt regarding our ability to continue as a going concern.
The total amount of the Second Installment Payment (as defined herein) and Milestone Payments (as defined herein) we may receive from the Transaction, and the amounts payable or due under the Profit Sharing Payments (as defined herein), are subject to various risks and uncertainties.
We have received a notice of the failure to satisfy a continued listing rule from The Nasdaq Stock Market LLC.
B usiness Overview 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 Soci t des Produits Nestl S.A., or SPN, and with certain of its affiliates, collectively, Nestl Health Science, in September 2024.
We are progressing the development of SER-155, an investigational, oral, live biotherapeutic designed to decolonize gastrointestinal, or GI, pathogens, improve epithelial barrier integrity, and regulate immune response to prevent bacterial bloodstream infections, or BSIs, as well as other pathogen-associated negative clinical outcomes in patients undergoing allogeneic hematopoietic stem cell transplantation, or allo-HSCT.
SER-155 and our other pipeline programs are designed to target multiple disease-relevant pathways and are manufactured from standard clonal cell banks via single-strain cultivation, rather than from the donor-sourced production process used for VOWST.