Just months after laying off a quarter of its workforce to fund a phase 2 study of its bloodstream infection preventive treatment, Seres Therapeutics is pausing that investment and sending more employees to the exits.
Back in September, Seres planned to go all-in on the midstage study of the microbiome therapy, dubbed SER-155, for the prevention of bloodstream infections in adults undergoing allogeneic hematopoietic stem cell transplant (allo-HSCT). The idea was to read out interim results within 12 months of the 248-person trial going live.
In an update this morning, the Cambridge, Massachusetts-based biotech explained it had gotten as far as submitting a final trial protocol to the FDA, as well as manufacturing the necessary drug substance and linking up with a CRO for the study, Seres said in a Feb. 12 release.
But that’s as far as the trial will get—at least for now. Seres disclosed that it is halting additional investment into the program and “will shift its operational focus to high-value earlier-stage pipeline programs while continuing to seek funding for the SER-155 phase 2 study.”
The refocus on SER-155 back in September had involved laying off 25% of employees to fund the planned phase 2 trial. Now, Seres explained that another 30% of its workforce will have to depart in order to “reduce operating costs.”
Seres ended last September with $47.6 million in the bank, which the company had expected to last until the second quarter of 2026. Even with the layoffs and other “runway extension actions,” Seres is only expecting its cash to keep the lights on until the third quarter.
Still, those extra months will provide “additional opportunities to advance development of its live biotherapeutic programs for inflammatory and immune diseases, and pursue potential collaborations,” the biotech explained.
With its allo-HSCT plans for SER-155 on ice for now, Seres will be prioritizing its preclinical programs like SER-603, a live biotherapeutic being developed for inflammatory and immune indications such as ulcerative colitis, Crohn's disease, and immune checkpoint-related enterocolitis (irEC).
Seres is currently in discussions with potential partners related to possible collaborations in these areas, according to the biopharma.
“As we shift our operational focus to our promising earlier-stage pipeline, we are now in a position to streamline our organization and cost structure,” Seres’ co-CEOs Thomas DesRosier and Marella Thorell said in the release.
“These cost-reduction initiatives and other actions are expected to extend our cash runway through the end of the third quarter of this year, supporting continued development of our programs for inflammatory and immune-related diseases, with targets validated by our previously reported preclinical and clinical datasets, and providing additional time to secure funding for our SER-155 phase 2 study,” they continued.
“In addition, as we pursue earlier stage programs with the greatest opportunity, such as those targeting inflammatory bowel disease, we are exploring collaborations to provide additional capital to the company,” DesRosier and Thorell added.
Seres is still expecting some clinical data from SER-155 courtesy of a study in collaboration with Memorial Sloan Kettering Cancer Center that is evaluating the therapy in 15 patients with irEC.
“We are looking forward to pending SER-155 clinical data in irEC that could further demonstrate the broad potential use cases for SER-155 and our live biotherapeutics more generally,” Seres Chief Scientific Officer Matthew Henn, Ph.D., said in the same release.
Data from that study are due to read out early in the second quarter, Henn added.
Seres is best known for Vowst, which become the first oral microbiome product to receive FDA approval as a therapeutic. The biopharma sold the rights to the Clostridioides difficile infection therapy to its commercialization partner Nestlé Health Science two years ago.
Seres has been struggling to fund its pipeline for a while. Back in November 2023, the company laid off about 160 employees to refocus on Vowst and SER-155.
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