CAMBRIDGE, Mass. - Seres Therapeutics, Inc. (NASDAQ:MCRB), a leader in live biotherapeutic products, announced promising results from its Phase 1b study of SER-155 in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). The study found a significant reduction in bacterial bloodstream infections (BSIs) and systemic antibiotic use, as well as a lower incidence of febrile neutropenia, compared to a placebo.
The investigational oral biotherapeutic SER-155 is designed to prevent gastrointestinal (GI)-derived bacterial bloodstream infections and other complications. The results showed SER-155 was generally well tolerated with no treatment-related serious adverse events reported.
The study included two cohorts, with the second cohort employing a randomized, double-blinded, placebo-controlled design to assess safety, drug strain engraftment in the GI tract, and other clinical endpoints. The incidence of BSIs in the SER-155 arm was significantly lower than the placebo arm, with a reduction in the duration of antibiotic treatment and a lower incidence of febrile neutropenia.
Seres intends to seek Breakthrough Therapy designation from the FDA due to the high unmet medical need associated with BSIs in allo-HSCT patients. The company also plans to evaluate SER-155 in other patient populations at high risk of serious bacterial infections.
The findings support Seres' strategy to develop live biotherapeutics for the prevention of serious bacterial infections in various medically vulnerable patient groups. The company holds worldwide rights for the commercialization of SER-155.
The Phase 1b results are based on a press release statement and further information will be discussed in a conference call hosted by Seres management. The ongoing development of SER-155, along with other pipeline programs, aims to address unmet needs in patient populations such as allo-HSCT, auto-HSCT, CAR-T, chronic liver disease, cancer neutropenia, and solid organ transplants.
In other recent news, Seres Therapeutics has disclosed financial statements for fiscal years 2023 and 2022, as part of a regulatory filing with the Securities and Exchange Commission. This disclosure comes in line with the planned sale of assets related to its VOWST microbiome therapeutic business. The sale of these assets to Nestle Health Science, for a cash transaction of $155 million, is expected to significantly strengthen Seres Therapeutics' financial position. The deal, set to close within the next 90 days, will allow the company to retire existing debt and support the development of its live biotherapeutic product pipeline.
Seres Therapeutics is focusing on advancing SER-155, which is currently in a Phase Ib study, with key clinical data expected soon. The company is also preparing SER-147 for IND readiness by the second half of 2025, targeting metabolic diseases. Despite a reported net loss of $32.9 million, the asset sale to Nestle is expected to extend the company's cash runway. These are the recent developments in Seres Therapeutics.
InvestingPro Insights
As Seres Therapeutics, Inc. (NASDAQ:MCRB) continues to make headway in the development of its live biotherapeutic products, the financial health and market performance of the company remain a point of interest for investors. According to InvestingPro data, MCRB has a market capitalization of $159.32 million, reflecting the company's size and market value as of recent. Despite the promising clinical results, the company's revenue over the last twelve months as of Q2 2024 stands at a mere $0.37 million, with a significant decline in revenue growth at -99.71%.
InvestingPro Tips highlight that Seres Therapeutics operates with a significant debt burden and is quickly burning through cash, which could be concerns for long-term sustainability. However, analysts have shown optimism by revising their earnings upwards for the upcoming period. It's also noteworthy that the company has experienced a strong return over the last week, month, and three months, with price total returns of 16.67%, 17.98%, and 40.83% respectively. These metrics suggest a recent uptick in investor confidence, potentially buoyed by the clinical advancements of SER-155.
For investors looking for more insights, there are additional InvestingPro Tips available, including analyses of the company's valuation, profitability expectations, and stock price volatility. For instance, Seres Therapeutics does not pay a dividend to shareholders, which might be relevant for those interested in income-generating investments. The full suite of tips can provide a more comprehensive view of the company's financial status and market expectations, and can be found at: https://www.investing.com/pro/MCRB.
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