Seres Therapeutics Reports Second Quarter 2025 Financial Results and Provides Business Updates
Following FDA input, Seres submitted Phase 2 study protocol to FDA for SER-155 for the prevention of bloodstream infections (BSIs) in adults undergoing allogeneic hematopoietic stem cell transplant (allo-HSCT) to treat hematological malignancies
Seres engaging with multiple parties regarding various deal structures, including potential business development and partnerships, intended to secure capital and other resources to enable the clinical advancement of SER-155 and additional live biotherapeutic product candidates
Seres received the
Conference call at 8:30 a.m. ET today
“We are in active discussions with multiple parties seeking capital and other resources to support further development of SER-155 for the prevention of BSIs and our broader portfolio of live biotherapeutic product candidates with applications for inflammatory diseases. The types of transactions we are evaluating include partnerships, out-licensing deals, mergers, and other structures to access capital, and aim to leverage Seres’ expertise and track record of successfully bringing a live biotherapeutic product to the market,” said
Recent Highlights
SER-155 and Bloodstream Infection Prevention
- Seres’ business development discussions are focused on supporting SER-155 clinical advancement. The Company is engaging with several parties regarding a range of deal structures including: partnerships, out-licensing deals, mergers, and other structures to access capital, and which could potentially leverage Seres’ live biotherapeutics expertise and experience successfully bringing a live biotherapeutic product from development through FDA approval.
- Based on prior
US Food and Drug Administration (FDA) feedback, Seres has continued preparations for a SER-155 Phase 2 study that could provide a time and capital-efficient path to obtaining clinical results. InMay 2025 , the Company filed the SER-155 Phase 2 protocol with the FDA and is anticipating FDA feedback, which is expected to support finalizing the protocol. - The SER-155 Phase 2 study is expected to enroll approximately 248 participants and incorporate an adaptive design and an interim data analysis when approximately half of the enrolled participants have reached the primary endpoint. The Company expects to obtain the interim clinical results within 12 months following study initiation, which it believes will facilitate timely engagement with the FDA on the design of a Phase 3 study and inform development in adjacent medically vulnerable patient populations. The Company believes that positive results from the Phase 2 study, if achieved, could enable advancement into a single Phase 3 trial to support registration.
- In
May 2025 , the Company presented new exploratory biomarker data from the SER-155 Phase 1b study in a poster session at theAmerican Society of Clinical Oncology (ASCO) Annual Meeting held inChicago . These data demonstrate the potential of SER-155 to promote immune reconstitution following allo-HSCT, by modulating homeostatic cytokines and peripheral T-cell expansion, and improve clinical outcomes in these patients.
Development of Biotherapeutics for the Treatment of Inflammatory and Immune Diseases
- The Company is collaborating with
Memorial Sloan Kettering Cancer Center on an investigator-sponsored trial (IST), now underway, to evaluate SER-155 in patients with immune checkpoint related enterocolitis (irEC). - In
May 2025 , Seres presented data at the Digestive Disease Week (DDW) conference describing a novel biomarker that may predict a more robust treatment response in patients with ulcerative colitis who are administered a biotherapeutic product. The Company received a Poster of Distinction award in the Microbiome and Microbial Therapies subgroup. These findings support the potential of live biotherapeutics as a novel treatment modality for gut-related inflammatory and immune diseases, suggesting that patient subpopulations well-suited for this approach may be identifiable. This research has been supported by the Crohn’s &Colitis Foundation . - Seres is exploring potential R&D partnerships to advance development of its investigational live biotherapeutics in inflammatory and immune diseases, including ulcerative colitis and Crohn’s disease.
Recent Corporate Updates
- Seres received the
$25 million installment payment from Nestlé Health Science (Nestlé) inJuly 2025 , as expected, and concurrently paid Nestlé$1.4 million in employment-related obligations. The Company has completed the majority of Transition Service Agreement (TSA) activities related to its VOWST™ asset sale to Nestlé . Thomas DesRosier andMarella Thorell were appointed co-Chief Executive Officers, effectiveAugust 1, 2025 . This followed the departure of our prior CEO,Eric Shaff , onJuly 31 2025 , after a decade with the Company, to pursue a new professional opportunity.Mr. DesRosier andMs. Thorell retain responsibilities related to their roles as Chief Legal Officer and Chief Financial Officer, respectively.Mr. Shaff will continue to serve as a Director on the Seres Board.- Effective
August 5, 2025 ,Robert Rosiello , an Executive Partner atFlagship Pioneering , joined the board of directors, filling a vacancy created by the resignation ofPaul Biondi , Managing Partner atFlagship Pioneering , from the board.Mr. Rosiello has served at Flagship since 2018, focusing on building capabilities to help grow the firm's portfolio companies. He previously held senior roles atMcKinsey & Company and served as EVP and CFO atValeant . He currently serves on several boards, includingSana Biotechnology (Nasdaq: SANA), theMarine Biological Laboratory , andCatholic Charities of New York .
Financial Results
The Company has classified all historical operating results for the VOWST business within discontinued operations in the consolidated statements of operations for the comparative periods presented (three and six months ended
- Seres reported a net loss from continuing operations of
$19.9 million for the second quarter of 2025, as compared to$26.2 million for the same period in 2024. - Research and development (R&D) expenses for the second quarter of 2025 were
$12.9 million , compared with $15.8 million for the second quarter of 2024. The decrease in R&D expenses was primarily driven by a decrease in expenses resulting from completion of the SER-155 Phase 1b study, lower personnel and related expenses, and a decrease in platform investments. - General and administrative (G&A) expenses for the second quarter of 2025 were $10.3 million, compared with $13.1 million for the second quarter of 2024. The decrease in G&A expenses was primarily a result of lower personnel and related expenses, including IT-related expenses.
- Manufacturing services expenses were
$1.7 million for the second quarter of 2025. These costs relate to the provision of manufacturing services under theTSA with Nestlé, which began in the fourth quarter of 2024. The reimbursement received from Nestlé related to these expenses is recognized in other income.
Cash Runway
As of June 30, 2025, Seres had $45.4 million in cash and cash equivalents. Based on the Company’s current cash position, the
Conference Call Information
Seres’ management will host a conference call today, August 6, 2025, at 8:30 a.m. ET. The conference call may be accessed by calling 1-800-715-9871 (international callers dial 1-646-307-1963) and referencing the conference ID number 3641971. To join the live webcast, please visit the “Investors and News” section of the Seres website at www.serestherapeutics.com. A webcast replay will be available on the Seres website beginning approximately two hours after the event and will be archived for at least 21 days.
About SER-155
SER-155 is an investigational, oral, live biotherapeutic designed to decolonize gastrointestinal (GI) pathogens, improve epithelial barrier integrity, and induce immune homeostasis, to prevent bacterial bloodstream infections, including those that can harbor antimicrobial resistance (AMR), as well as other pathogen associated negative clinical outcomes, in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).
SER-155 has been evaluated in a Phase 1b placebo-controlled study in patients undergoing allo-HSCT, which demonstrated a significant reduction in both bacterial bloodstream infections (BSIs) (77% relative risk reduction) and systemic antibiotic exposure, as well as lower incidence of febrile neutropenia. SER-155 has received Breakthrough Therapy designation for the reduction of bloodstream infections in adults undergoing allo-HCST and Fast Track designation for reducing the risk of infection and graft-versus-host disease in patients undergoing allo-HCST. The early development of the program was supported by Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), a global non-profit partnership accelerating antibacterial products to address drug-resistant bacteria.
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: the timing and results of our clinical studies and data readouts; current or future product candidates and their potential benefits; clinical development plans and commercial opportunities; communications with, feedback from, or submissions to the FDA; operating plans, cost reduction actions, and our future cash runway; our ability to secure a strategic, R&D, or other partnership and/or generate or obtain additional capital, financing or other resources; our planned strategic focus; the anticipated timing of any of the foregoing; 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 limited operating history; (5) the expected payments from the VOSWT sale are subject to risks and uncertainties; (6) 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; (7) we have in the past and may in the future receive notice of the failure to satisfy a continued listing rule from
CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited, in thousands, except share and per share data) |
||||||||
| 2025 | 2024 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 45,379 | $ | 30,793 | ||||
| Accounts receivable due from SPN - related party | 882 | 2,068 | ||||||
| Prepaid expenses and other current assets (1) | 2,424 | 5,813 | ||||||
| Total current assets | 48,685 | 38,674 | ||||||
| Property and equipment, net | 9,622 | 11,534 | ||||||
| Operating lease assets | 76,794 | 80,903 | ||||||
| Restricted cash | 8,668 | 8,668 | ||||||
| Other non-current assets | 31 | 31 | ||||||
| Total assets | $ | 143,800 | $ | 139,810 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,200 | $ | 4,079 | ||||
| Accrued expenses and other current liabilities | 5,809 | 10,719 | ||||||
| Accrued liabilities due to SPN - related party | 13,453 | 17,750 | ||||||
| Operating lease liabilities | 9,478 | 8,674 | ||||||
| Total current liabilities | 30,940 | 41,222 | ||||||
| Operating lease liabilities, net of current portion | 77,956 | 82,966 | ||||||
| Other long-term liabilities | 1,954 | 1,838 | ||||||
| Total liabilities | 110,850 | 126,026 | ||||||
| Commitments and contingencies (Note 9) | ||||||||
| Stockholders’ equity (deficit): | ||||||||
| Preferred stock, |
— | — | ||||||
| Common stock, |
9 | 9 | ||||||
| Additional paid-in capital | 998,213 | 991,874 | ||||||
| Accumulated other comprehensive loss | — | — | ||||||
| Accumulated deficit | (965,272 | ) | (978,099 | ) | ||||
| Total stockholders’ equity | 32,950 | 13,784 | ||||||
| Total liabilities and stockholders’ equity | $ | 143,800 | $ | 139,810 | ||||
[1] Includes
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) (unaudited, in thousands, except share and per share data) |
|||||||||||||||
| Three Months Ended |
Six Months Ended |
||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Operating expenses: | |||||||||||||||
| Research and development expenses | $ | 12,939 | $ | 15,806 | $ | 24,760 | 35,300 | ||||||||
| General and administrative expenses | 10,253 | 13,065 | 22,141 | 28,009 | |||||||||||
| Manufacturing services | 1,689 | — | 5,216 | — | |||||||||||
| Total operating expenses | 24,881 | 28,871 | 52,117 | 63,309 | |||||||||||
| Loss from operations | (24,881 | ) | (28,871 | ) | (52,117 | ) | (63,309 | ) | |||||||
| Other income (expense): | |||||||||||||||
| Gain on sale of VOWST Business | 185 | — | 52,366 | — | |||||||||||
| Interest income | 546 | 1,230 | 1,164 | 2,878 | |||||||||||
| Interest expense | — | — | — | — | |||||||||||
| Other income (2) | 4,295 | 1,445 | 11,414 | 1,332 | |||||||||||
| Total other income, net | 5,026 | 2,675 | 64,944 | 4,210 | |||||||||||
| Net income (loss) from continuing operations | $ | (19,855 | ) | $ | (26,196 | ) | $ | 12,827 | $ | (59,099 | ) | ||||
| Net (loss) from discontinued operations, net of tax | $ | — | $ | (6,674 | ) | $ | — | $ | (13,904 | ) | |||||
| Net income (loss) and comprehensive income (loss) | $ | (19,855 | ) | $ | (32,870 | ) | $ | 12,827 | $ | (73,003 | ) | ||||
| Net income (loss) from continuing operations per share attributable to common stockholders - basic | $ | (2.27 | ) | $ | (3.46 | ) | $ | 1.47 | $ | (7.94 | ) | ||||
| Net (loss) from discontinued operations per share attributable to common stockholders - basic | $ | — | $ | (0.88 | ) | $ | — | $ | (1.87 | ) | |||||
| Net income (loss) per share attributable to common stockholders - basic | $ | (2.27 | ) | $ | (4.34 | ) | $ | 1.47 | $ | (9.81 | ) | ||||
| Net income (loss) from continuing operations per share attributable to common stockholders - diluted | $ | (2.27 | ) | $ | (3.46 | ) | $ | 1.47 | $ | (7.94 | ) | ||||
| Net (loss) from discontinued operations per share attributable to common stockholders - diluted | $ | — | $ | (0.88 | ) | $ | — | $ | (1.87 | ) | |||||
| Net income (loss) per share attributable to common stockholders - diluted | $ | (2.27 | ) | $ | (4.34 | ) | $ | 1.47 | $ | (9.81 | ) | ||||
| Weighted average common shares outstanding - basic | 8,743,733 | 7,575,620 | 8,723,589 | 7,440,323 | |||||||||||
| Weighted average common shares outstanding - diluted | 8,743,733 | 7,575,620 | 8,732,176 | 7,440,323 | |||||||||||
[2] Includes
Investor and Media Contact:
IR@serestherapeutics.com
Kendall Investor Relations
ctanzi@kendallir.com
Source: Seres Therapeutics, Inc.