CAMBRIDGE, Mass. - Seres Therapeutics, Inc. (NASDAQ:MCRB), a $140 million market cap leader in live biotherapeutics, announced today that the FDA has awarded Breakthrough Therapy designation to its investigational drug SER-155. According to InvestingPro analysis, the company's stock is currently trading below its Fair Value, despite showing strong revenue growth of over 12,800% in the last twelve months. The designation is for the reduction of bloodstream infections in adult patients undergoing allogeneic hematopoietic stem cell transplant (allo-HSCT) for hematological malignancies.
In September 2024, Seres released data from a Phase 1b study showing SER-155 led to a 77% relative risk reduction in bacterial bloodstream infections compared to placebo. The study also showed lower systemic antibiotic exposure and febrile neutropenia incidence. SER-155 was generally well tolerated with no treatment-related serious adverse events observed.
The Breakthrough Therapy designation, which is the second for the company, provides Seres with more intensive FDA guidance and a potentially expedited review process. This comes after the drug received Fast Track designation in December 2023 for reducing infection risk and Graft-versus-Host Disease (GvHD) in the same patient population.
The positive clinical trial results are significant as bloodstream infections are a frequent and often fatal complication in allo-HSCT patients. Traditional antibiotic prophylaxis does not address the underlying causes of these infections, which SER-155 is designed to do by modulating the microbiome.
Seres is preparing to meet with the FDA in the first quarter of 2025 to discuss the next clinical study of SER-155, potentially a single registrational study for efficacy. With a current ratio of 1.12 and significant cash burn rate, as highlighted by InvestingPro's analysis, the company is strategically seeking a partnership to accelerate the next study in allo-HSCT and expand SER-155's use to other high-risk patient populations. InvestingPro subscribers have access to 11 additional key insights about Seres' financial health and market position.
The recent market research by Seres identified a significant commercial opportunity for SER-155 in allo-HSCT. Health Care Providers indicated a high level of concern regarding bloodstream infections and expressed willingness to integrate a product like SER-155 into standard treatment protocols.
Seres' pursuit of a partner is part of its strategy to maximize the program opportunity while maintaining a capital-efficient development approach. With a beta of 2.08 indicating higher market volatility, investors seeking detailed analysis can access the comprehensive Pro Research Report available on InvestingPro, which provides deep-dive analysis of the company's financial health and growth prospects. The company's focus remains on improving patient outcomes in medically vulnerable populations with its pipeline of live biotherapeutic products.
This news article is based on a press release statement from Seres Therapeutics, Inc.
In other recent news, Seres Therapeutics has announced significant clinical and financial milestones in its Q3 2024 earnings call. The biopharmaceutical company reported promising results from its SER-155 Phase Ib clinical trial, showing a 77% reduction in bacterial bloodstream infections among patients. On the financial front, despite a net loss of $51 million, largely due to the extinguishment of Oaktree debt, Seres completed the VOWST sale to Nestlé Health Science, which provided substantial upfront cash and allowed the company to retire debt.
Seres is also making strides in its research and development initiatives, actively seeking partnerships to enhance its clinical development capabilities. The company is focused on developing its live biotherapeutic programs, particularly SER-155 and SER-147. The former is seen as a transformative product for patients with allo-HSCT, with potential to expand to other hematologic malignancies.
These developments follow the company's strategy of leveraging SER-155 to address bacterial bloodstream infections in multiple patient populations. The company's financial position includes $66.8 million in cash, which is expected to fund operations into Q4 2025. These are all recent developments that investors should take note of.
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