Seres Therapeutics Announces Appointment of Richard N. Kender as Executive Chair and Interim CEO; Provides Business Updates
Accomplished pharmaceutical executive brings extensive business development, licensing and finance experience
Seres is implementing a focused corporate strategy to advance live biotherapeutic programs in inflammatory and immune diseases and support the readout of investigator-sponsored SER-155 study in immune checkpoint–related enterocolitis, a frequent and serious side effect in cancer patients treated with immune checkpoint inhibitors, expected in Q2 2026
SER-155 is Phase 2 ready for patients undergoing allogeneic hematopoietic stem cell transplant (allo-HSCT) to treat hematologic malignancies (cancers of the blood, bone marrow, and lymph nodes); efforts to secure funding for the program continue
Company to host conference call tomorrow,
As announced last month, Seres has implemented a corporate strategy to advance its live biotherapeutic programs in inflammatory and immune (I&I) diseases, with a focus on inflammatory bowel disease (IBD) and immune checkpoint-related enterocolitis (irEC). A clinical readout from the fully enrolled investigator-sponsored SER-155 study in irEC, being conducted at
“I also welcome my fellow director,
In connection with Seres’ early-stage strategic focus,
Recent Pipeline Updates
- The Company continues to advance its preclinical stage LBP candidates, including SER-603. SER-603 is a novel LBP designed to act via key mechanisms by addressing disruptions in the GI microbiome and improving GI mucosal barrier integrity to reduce the translocation of inflammatory molecules, barrier inflammation, and to induce immune homeostasis in IBD patients. The Company is conducting IND-enabling activities for SER-603 and is engaging with potential collaborators to support clinical advancement of this program, with the potential to deliver differentiated therapeutic benefits to IBD patients as a combination or mono therapy.
- A SER-155 investigator-sponsored trial, being conducted in collaboration with
Memorial Sloan Kettering Cancer Center , is fully enrolled with 15 participants with irEC and clinical data are expected in Q2 2026. The readout is expected to include initial safety, efficacy, pharmacology, and exploratory biomarker data. irEC is among the most frequent and severe immune-related adverse events (irAEs) in recipients of ICI therapy and can be observed in up to 50% of patients, with rates varying based on cancer drug and treatment regimen. Current treatment guidelines for irEC include discontinuation of ICI and initiation of immunosuppressive steroids, followed by the addition of further immunosuppressive agents for patients without prompt response. However, these current treatment approaches have limitations, including risk of toxicity and diminished ICI efficacy. SER-155 is designed to allow cancer patients to remain on or re-introduce ICI therapy and avoid the risk of immunosuppressive drugs in this medically vulnerable patient population. ICIs can cause a wide range of irAEs with links to T cell biology and epithelial barrier inflammation, both of which are biological functions shown in preclinical and clinical pharmacology data to be positively impacted by SER-155. - SER-155 allo-HSCT Phase 2 preparatory activities, including submission of a final protocol to FDA, engagement with potential study sites, and manufacturing of drug substance, have advanced to support further development of SER-155, which has received Breakthrough Therapy designation for the prevention of serious bloodstream infections in patients undergoing allo-HSCT for hematological malignancies. Efforts to secure funding to commence the study remain ongoing.
- With a grant from CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) whose goal is to accelerate development of antibacterial products to address drug-resistant bacteria, Seres is progressing development of an oral liquid formulation of an LBP based on SER-155 strains, for dosing in patients who cannot take oral capsules, such as intubated patients in the ICU, and other medically vulnerable patients at high risk of antimicrobial resistant infections.
Cash and Cash Runway
As of December 31, 2025, Seres had approximately
Conference Call Information and Future Quarterly Call Plans
Seres’ management will host a conference call tomorrow,
The Company plans to communicate annual and quarterly financial results and business updates via press release and, going forward, does not plan to host earnings conference calls. The 2025 financial results and business update are expected to be announced on
About
Richard N. Kender is a recognized business leader with an extensive career in the pharmaceutical industry, including 35 years spent at Merck & Co., Inc. During his tenure at Merck, he held various roles across corporate development, including M&A, licensing, financial evaluation and analysis, and global competitive intelligence. Most recently, he served as Senior Vice President, Business Development and Corporate Licensing from 2000 until his retirement in 2013. Throughout his career, he has been involved in numerous strategic transactions and played an instrumental role in Merck’s acquisition of Schering-Plough. Mr. Kender currently serves on the board of directors of Longeveron and previously served on the boards of numerous public and private companies, including
About
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements about: clinical development plans for SER-155; our strategy; advancement of our early stage programs; potential collaborations; our expected cash runway; the timing and results of our clinical studies and data readouts; past, current or future products or product candidates and their potential benefits; the anticipated timing of any of the foregoing; the impact and expectations of our officer appointments; and other statements that are not historical fact.
These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: (1) our need for additional funding; (2) our ability to continue as a going concern; (3) we have incurred significant losses, are not currently profitable and may never become profitable; (4) our cost reduction actions may not achieve their intended benefits, including an extended cash runway; (5) our limited operating history; (6) the expected payments from the VOSWT sale are subject to risks and uncertainties; (7) we may not be able to realize the anticipated benefits of the VOWST sale, and may face new challenges as a smaller, less diversified company; (8) we have in the past and may in the future receive notice of the failure to satisfy a continued listing rule from
Investor and Media Contact:
IR@serestherapeutics.com
Kendall Investor Relations
ctanzi@kendallir.com
Source: Seres Therapeutics, Inc.
