Seres Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Updates
Seres Therapeutics (MCRB) reported its Q4 and full year 2024 financial results, highlighting significant progress with SER-155, their live biotherapeutic candidate for preventing bloodstream infections in allogeneic hematopoietic stem cell transplant recipients.
Key developments include:
- SER-155 showed a 77% relative risk reduction in bloodstream infections in Phase 1b study
- FDA granted Breakthrough Therapy designation in December 2024
- Company plans to submit draft protocol for next study to FDA in Q2 2025
- Recent FDA feedback supports bloodstream infection reduction at day 30 post-HSCT as primary endpoint
Financial highlights: Net loss from continuing operations was $125.8M for 2024, compared to $190.1M in 2023. Cash position of $30.8M as of December 31, 2024, with expected funding into Q1 2026, including anticipated Nestlé payments.
Seres Therapeutics (MCRB) ha riportato i risultati finanziari del quarto trimestre e dell'intero anno 2024, evidenziando progressi significativi con SER-155, il loro candidato bioterapeutico vivo per la prevenzione delle infezioni del sangue nei riceventi di trapianti di cellule staminali ematopoietiche allogeniche.
Sviluppi chiave includono:
- SER-155 ha mostrato una riduzione del rischio relativo del 77% nelle infezioni del sangue nello studio di Fase 1b
- La FDA ha concesso la designazione di Terapia Innovativa nel dicembre 2024
- La società prevede di presentare un protocollo preliminare per il prossimo studio alla FDA nel secondo trimestre del 2025
- Il feedback recente della FDA supporta la riduzione delle infezioni del sangue al giorno 30 post-HSCT come obiettivo primario
Risultati finanziari: La perdita netta dalle operazioni continuative è stata di 125,8 milioni di dollari per il 2024, rispetto ai 190,1 milioni di dollari nel 2023. Posizione di cassa di 30,8 milioni di dollari al 31 dicembre 2024, con finanziamenti previsti fino al primo trimestre del 2026, inclusi i pagamenti attesi da Nestlé.
Seres Therapeutics (MCRB) reportó sus resultados financieros del cuarto trimestre y del año completo 2024, destacando avances significativos con SER-155, su candidato bioterapéutico vivo para prevenir infecciones en el torrente sanguíneo en receptores de trasplantes de células madre hematopoyéticas alogénicas.
Desarrollos clave incluyen:
- SER-155 mostró una reducción del riesgo relativo del 77% en infecciones del torrente sanguíneo en el estudio de Fase 1b
- La FDA otorgó la designación de Terapia Innovadora en diciembre de 2024
- La empresa planea presentar un protocolo preliminar para el próximo estudio a la FDA en el segundo trimestre de 2025
- Los comentarios recientes de la FDA respaldan la reducción de infecciones del torrente sanguíneo a los 30 días post-HSCT como objetivo primario
Aspectos financieros: La pérdida neta de las operaciones continuas fue de 125,8 millones de dólares para 2024, en comparación con 190,1 millones de dólares en 2023. Posición de efectivo de 30,8 millones de dólares al 31 de diciembre de 2024, con financiamiento esperado hasta el primer trimestre de 2026, incluidos los pagos anticipados de Nestlé.
Seres Therapeutics (MCRB)는 2024년 4분기 및 연간 재무 결과를 보고하며, 조혈모세포 이식 수혜자의 혈류 감염 예방을 위한 생물학적 치료 후보물질 SER-155의 중요한 진전을 강조했습니다.
주요 개발 사항은 다음과 같습니다:
- SER-155는 1b상 연구에서 혈류 감염의 상대적 위험을 77% 감소시켰습니다.
- FDA는 2024년 12월에 혁신 치료제 지정을 승인했습니다.
- 회사는 2025년 2분기에 다음 연구를 위한 초안 프로토콜을 FDA에 제출할 계획입니다.
- 최근 FDA의 피드백은 HSCT 후 30일에 혈류 감염 감소를 주요 목표로 지원합니다.
재무 하이라이트: 2024년 지속 운영으로 인한 순손실은 1억 2,580만 달러였으며, 2023년의 1억 9,010만 달러와 비교됩니다. 2024년 12월 31일 기준 현금 보유액은 3천 80만 달러이며, 2026년 1분기까지 자금이 예상되며, Nestlé의 지불이 포함됩니다.
Seres Therapeutics (MCRB) a publié ses résultats financiers du quatrième trimestre et de l'année complète 2024, mettant en évidence des progrès significatifs avec SER-155, leur candidat biothérapeutique vivant pour prévenir les infections sanguines chez les receveurs de greffes de cellules souches hématopoïétiques allogéniques.
Les développements clés incluent :
- SER-155 a montré une réduction du risque relatif de 77 % des infections sanguines dans l'étude de Phase 1b
- La FDA a accordé la désignation de Thérapie Innovante en décembre 2024
- L'entreprise prévoit de soumettre un protocole préliminaire pour la prochaine étude à la FDA au deuxième trimestre 2025
- Les retours récents de la FDA soutiennent la réduction des infections sanguines au jour 30 après HSCT comme objectif principal
Points financiers : La perte nette des opérations continues s'élevait à 125,8 millions de dollars pour 2024, contre 190,1 millions de dollars en 2023. La position de trésorerie était de 30,8 millions de dollars au 31 décembre 2024, avec un financement prévu jusqu'au premier trimestre 2026, y compris les paiements anticipés de Nestlé.
Seres Therapeutics (MCRB) hat seine finanziellen Ergebnisse für das vierte Quartal und das gesamte Jahr 2024 veröffentlicht und erhebliche Fortschritte mit SER-155 hervorgehoben, ihrem lebenden biotherapeutischen Kandidaten zur Prävention von Blutstrominfektionen bei Empfängern von allogenen hämatopoetischen Stammzelltransplantationen.
Wichtige Entwicklungen umfassen:
- SER-155 zeigte eine relative Risikominderung von 77 % bei Blutstrominfektionen in der Phase-1b-Studie
- Die FDA erteilte im Dezember 2024 die Bezeichnung als Durchbruchtherapie
- Das Unternehmen plant, im zweiten Quartal 2025 ein vorläufiges Protokoll für die nächste Studie bei der FDA einzureichen
- Das jüngste Feedback der FDA unterstützt die Reduzierung von Blutstrominfektionen am Tag 30 nach HSCT als primäres Ziel
Finanzielle Höhepunkte: Der Nettoverlust aus fortgeführten Betrieben betrug 125,8 Millionen USD für 2024, im Vergleich zu 190,1 Millionen USD im Jahr 2023. Die Liquiditätsposition betrug zum 31. Dezember 2024 30,8 Millionen USD, mit einer erwarteten Finanzierung bis zum ersten Quartal 2026, einschließlich der zu erwartenden Zahlungen von Nestlé.
- SER-155 achieved 77% reduction in bloodstream infections in Phase 1b study
- Received FDA Breakthrough Therapy designation for SER-155
- Reduced R&D expenses from $117.6M in 2023 to $64.6M in 2024
- Expected $25M installment payment from Nestlé in July 2025
- Potential for up to $275M in future milestone payments from VOWST sale
- Net loss from continuing operations of $125.8M in 2024
- Cash runway only extends into Q1 2026
- Requires external partnership to maximize SER-155 opportunity
Insights
Seres Therapeutics' financial results reveal a substantially improved financial position following the VOWST business sale to Nestlé, which generated
The company significantly reduced its operating expenses, with R&D costs declining
With
Seres' SER-155 program demonstrates compelling clinical promise based on the 77% relative risk reduction in bloodstream infections observed in their Phase 1b study of allogeneic hematopoietic stem cell transplant patients. This significant efficacy signal prompted the FDA to grant Breakthrough Therapy designation, accelerating the regulatory pathway.
The FDA feedback on SER-155's development provides important regulatory validation by supporting reduction in bloodstream infections at 30 days post-transplant as the primary efficacy endpoint. This alignment with regulators reduces development risk as Seres prepares its next clinical protocol for Q2 2025 submission.
The recently reported translational biomarker data strengthens the scientific case for SER-155 by confirming its dual mechanisms of action: improving intestinal barrier integrity and reducing systemic inflammatory responses. The observed decreases in inflammatory markers (IFN-γ, TNF-α, IL-17, and IL-8) during the critical peri-transplant period provide mechanistic validation that correlates with the clinical outcomes.
Market research indicates strong receptivity among healthcare professionals and payers, highlighting the significant unmet need in preventing dangerous infections in these immunocompromised patients. With approximately 9,300 allo-HSCT procedures annually in the US and 20,000 in Europe, SER-155 addresses a concentrated but valuable market. The potential expansion into additional vulnerable populations (autologous-HSCT, CAR-T recipients, chronic liver disease patients) represents significant upside beyond the core indication.
Recent FDA feedback received on SER-155 allogeneic hematopoietic stem cell transplant (allo-HSCT) next study provides support for the proposed primary efficacy endpoint of reduction in bloodstream infections (BSIs) at day 30 post-HSCT; Company expects to submit draft study protocol to FDA in Q2 2025
SER-155 Phase 1b placebo-controlled study exploratory translational biomarker data reinforce intended mechanisms of action, are consistent with clinical results that showed a significant reduction (
Company advances SER-155 strategic partnership discussions to accelerate next study in allo-HSCT and support potential expansion into other target populations
With current cash, expected second installment payment from Nestlé, and based on current operating plans, Seres expects to fund operations into Q1 2026
Conference call at 8:30 a.m. ET today
CAMBRIDGE, Mass., March 13, 2025 (GLOBE NEWSWIRE) -- Seres Therapeutics, Inc. (Nasdaq: MCRB), (Seres or the Company), a leading live biotherapeutics company, today reported fourth quarter and full year 2024 financial results and provided business updates.
“We have made significant progress advancing SER-155 as a novel live biotherapeutic candidate designed to prevent life-threatening bloodstream infections in allo-HSCT recipients,” said Eric Shaff, President and Chief Executive Officer of Seres. “Based on the strength of our Phase 1b placebo-controlled clinical results showing a relative risk reduction of
Mr. Shaff continued, “Recently released exploratory translational biomarker results from our SER-155 Phase 1b study provide supportive mechanistic data, consistent with the observed clinical results that showed a reduction in the risk of BSIs. We believe the data also offer further evidence of the potential of Seres’ biotherapeutic approach to benefit patients living with inflammatory and immune diseases such as ulcerative colitis and Crohn’s disease. The market opportunity for SER-155 is significant, with clinician and payer research indicating that SER-155, if approved, could result in rapid and deep utilization in allo-HSCT, as well as other sizable patient groups at high risk of BSIs. Our efforts and investments this year are focused on preparing for the next study of SER-155 in allo-HSCT and continued pursuit of an external partnership with a counterparty who shares our vision to maximize the SER-155 clinical and commercial opportunity.”
Pipeline Highlights
- In September 2024, Seres reported topline clinical data from Cohort 2 of its SER-155 Phase 1b placebo-controlled study in patients undergoing allo-HSCT. Study results demonstrate that SER-155 was associated with a
77% relative risk reduction in bloodstream infections, a significant reduction in systemic antibiotic exposure, as well as a lower incidence of febrile neutropenia, in each case as compared to placebo, through day 100 post-HSCT. SER-155 was generally well tolerated, with no observed treatment-related serious adverse events.
- In December 2024, the US Food and Drug Administration (FDA) granted Breakthrough Therapy designation to SER-155 for reduction of bloodstream infections in adults undergoing allo-HSCT. Breakthrough Therapy designation grants access to senior management at FDA and more communication and guidance from FDA to expedite the development of medicines where preliminary clinical evidence indicates that a drug may demonstrate substantial improvement over existing therapies, on one or more clinically significant endpoints, and which are intended to treat a serious or life-threatening disease or condition.
- Seres recently received constructive feedback from the FDA regarding the development strategy for SER-155 in patients undergoing allo-HSCT. The FDA provided input on important elements of the next study, including a recommendation for a Phase 2 and support for a reduction in bloodstream infections 30 days post HSCT as the primary endpoint, and confirmed their expectations for the manufacture and control of SER-155. Incorporating the feedback, Seres is designing the next SER-155 allo-HSCT study, which the Company believes could be either a standalone Phase 2, or a Phase 2 as part of a Phase 2/3 seamless design. Both development paths are expected to include an adaptive design, with meaningful interim data analysis, when approximately half of the enrolled patients have reached the primary endpoint timepoint, informing the study path forward and potential indication expansion. The next study protocol will preserve many elements of the successful SER-155 Phase 1b study. Seres plans to submit the draft protocol, which the Company anticipates will be informed by potential further FDA interaction and partnership discussions, to the FDA in Q2 2025 to obtain further feedback.
- In January 2025, the Company reported exploratory translational biomarker data from its SER-155 Phase 1b study which provided evidence supporting the intended therapeutic mechanisms, including promotion of intestinal epithelial barrier integrity to reduce the potential of bacterial translocation into the bloodstream, and reduction of systemic inflammatory responses. Results from this exploratory biomarker analysis showed that SER-155 was associated with lower levels of fecal albumin and lower concentrations of various plasma biomarkers associated with systemic inflammation (i.e., IFN-, TNF-α, IL-17, and IL-8) in the HSCT peri-transplant period, the period from the end of the first SER-155 treatment course through to neutrophil engraftment. The results support SER-155's intended mechanisms of action and reinforce the previously reported promising clinical study efficacy and safety data. These systemic inflammatory response observations further support the potential to develop Seres’ live biotherapeutics to address inflammatory and immune diseases, including ulcerative colitis and Crohn’s disease. The SER-155 biomarker results were presented as a poster at the February 2025 Tandem Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and Center for International Blood and Marrow Transplant Research (CIBMTR). SER-155 Phase 1b clinical study data were also featured in an oral presentation in the Best Abstracts in Infectious Diseases track at the Tandem meeting.
- Market research conducted with US healthcare professionals (HCPs) and payers supported the high unmet need to prevent BSIs in allo-HSCT patients. Both HCPs and payers indicated an awareness of the high clinical burden of BSIs, driven by the high frequency of occurrences and poor associated outcomes. Both groups cited a lack of efficacious prophylactic therapies and expressed significant ongoing concerns around the risk of BSIs, febrile neutropenia, sepsis, and antibiotic-resistant infections. The observed degree of SER-155 risk reduction of BSIs and related clinical benefits were seen as clinically meaningful and supportive of a strong value proposition. US payers shared an expectation that coverage of SER-155 would be under the outpatient pharmacy benefit, given its oral administration, which would allow for dosing outside of the inpatient hospital setting. SER-155 in allo-HSCT alone represents a significant commercial opportunity based on market research indicating broad adoption by clinicians of an efficacious and well-tolerated option to prevent BSIs in these patients. There are an estimated 9,300 allo-HSCT procedures conducted annually in the US. The European Society for Bone Marrow Transplant recently updated its incidence estimates for Europe, reporting approximately 20,000 procedures in 2023. The opportunity in Europe is expected to be similarly robust to the US, driven by shared market dynamics such as unmet need and cost of HSCT and BSIs to the healthcare system.
- Seres continues to evaluate broader opportunities to address life-threatening infections, including anti-microbial resistance (AMR) infections, for SER-155 and other cultivated live biotherapeutic candidates, including pipeline candidate SER-147, in other medically vulnerable patient populations, including autologous-HSCT patients, cancer patients with neutropenia, CAR-T recipients, individuals with chronic liver disease, solid organ transplant recipients, as well as patients in the intensive care unit and long-term acute care facilities. The Company is also exploring targeting inflammatory and immune diseases, specifically ulcerative colitis and Crohn’s disease, with support from the Crohn’s & Colitis Foundation.
Recent Corporate Updates
- In September 2024, Seres announced the sale of its VOWST business to Société des Produits Nestlé S.A (SPN, and with certain of its affiliates, collectively, Nestlé Health Science or Nestlé). Seres received gross proceeds of approximately
$175 million , including payment of an up-front, prepaid milestone and equity investment, less approximately$20 million in settlement of net obligations payable to Nestlé. Seres received an installment payment of$50 million in January 2025 and expects to receive a second installment payment of$25 million (less up to approximately$1.5 million in employment-related obligations) in July 2025, subject to the Company’s material compliance with its transition obligations. The Company is also eligible to receive future milestone payments of up to$275 million based on VOWST worldwide net sales.
- In February 2025, the Company appointed Hans-Juergen Woerle, M.D., as a director and member of the Science and Clinical Development Committee. Dr. Woerle is the Chief Medical Officer and Chief Scientific Officer at Nestlé Health Science S.A. His appointment fulfills the rights granted to Nestlé upon their equity investment in Seres pursuant to the VOWST transaction in September 2024.
Anticipated Upcoming Milestones and Events
- Submit to FDA a draft protocol for the next study of SER-155 in allo-HSCT in Q2 2025.
- Present SER-155 Phase 1b clinical and exploratory translational biomarker data as a Top 100 abstract at the European Bone Marrow Transplant meeting in March 2025, facilitating engagement with potential European investigators in support of the Company’s planned global study. Additionally, exploratory translational biomarker data from across Seres’ programs, including in allo-HSCT and IBD, have been accepted for poster presentations at Digestive Disease Week (DDW) in May 2025.
- Expecting receipt of a
$25 million (less approximately$1.5 million in employment related obligations) installment payment from Nestlé in July 2025.
Financial Results
In the December 31, 2024 financial statements, the Company has classified the VOWST business as discontinued operations in the consolidated balance sheet for the comparative period (December 31, 2023), and all historical operating results for the VOWST business are reflected within discontinued operations in the consolidated statements of operations for all periods presented.
- Seres reported a net loss from continuing operations of
$125.8 million for the full year 2024, as compared to a net loss from continuing operations of$190.1 million for 2023. Seres reported a net loss from continuing operations of$15.7 million for the fourth quarter of 2024, as compared to a net loss from continuing operations of$34.7 million for the same period in 2023. - Research and development (R&D) expenses for the year ended December 31, 2024 were
$64.6 million , compared with$117.6 million for the same period in 2023. The year-over-year decrease in R&D expenses was primarily driven by lower personnel expenses and a decrease in platform investments as the Company focuses on its lead program, SER-155. R&D expenses for the fourth quarter of 2024 were$12.8 million , compared with$23.0 million for the fourth quarter of 2023. - General and administrative (G&A) expenses for the year ended December 31, 2024 were
$53.2 million , compared with$77.5 million for the same period in 2023. The year-over-year decrease in G&A expenses was primarily a result of reduced personnel and contractor expenses and cost management activities. G&A expenses for the fourth quarter of 2024 were$12.5 million , compared with$14.0 million for the fourth quarter of 2023. - Manufacturing Services expenses, a new category in 2024, were
$3.5 million for the year and the quarter ended December 31, 2024. These costs relate to the provision of manufacturing services under the transition services agreement with Nestlé. The associated reimbursement received from Nestlé related to these expenses is recognized in other (expense) income, net. - Net income from discontinued operations, net of tax, was
$125.9 million for 2024, as compared to$76.4 million for the same period in 2023. The difference was primarily the result of the gain on the sale of the VOWST business, net of tax, of approximately$146.7 million , which was recognized upon completion of the VOWST sale in September 2024.
Cash Runway
As of December 31, 2024, Seres had
Conference Call Information
Seres’ management will host a conference call today, March 13, 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 6331602. 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 tolerance to prevent bacterial bloodstream and antimicrobial resistant (AMR) infections, 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) 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 Seres Therapeutics
Seres Therapeutics, Inc. (Nasdaq: MCRB) is a clinical-stage company focused on improving patient outcomes in medically vulnerable populations through novel live biotherapeutics. Seres led the successful development and approval of VOWST™, the first FDA-approved orally administered microbiome therapeutic, which was sold to Nestlé Health Science in September 2024. The Company is developing SER-155, which has received Breakthrough Therapy designation for the reduction of bloodstream infections in adults undergoing allo-HSCT and Fast Track designation for reducing the risk of infection and graft-versus-host disease in adults undergoing allo-HSCT, and which has demonstrated a significant reduction in bloodstream infections and related complications (as compared to placebo) in a Phase 1b clinical study in patients undergoing allo-HSCT. SER-155 and the Company's other pipeline programs are designed to target multiple disease-relevant pathways and are manufactured from standard clonal cell banks via cultivation, rather than from the donor-sourced production process used for VOWST. In addition to allo-HSCT, the Company intends to evaluate SER-155 and other cultivated live biotherapeutic candidates in other medically vulnerable patient populations including autologous-HSCT patients, cancer patients with neutropenia, CAR-T recipients, individuals with chronic liver disease, solid organ transplant recipients, as well as patients in the intensive care unit and long-term acute care facilities. For more information, visit www.serestherapeutics.com.
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; future product candidates, clinical development plans and commercial opportunities; communications with, feedback from, or submissions to the FDA; future payments related to the VOWST sale; operating plans and our future cash runway; our ability to secure a partnership and/or generate additional capital; our planned strategic focus; 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 history of operating losses; (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 received a notice of the failure to satisfy a continued listing rule from The Nasdaq Stock Market LLC; (8) our novel approach to therapeutic intervention; (9) our reliance on third parties to conduct our clinical trials and manufacture our product candidates; (10) our ability to achieve market acceptance necessary for commercial success; (11) the competition we will face; (12) our ability to protect our intellectual property; and (13) our ability to retain key personnel and to manage our growth. These and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC), on March 13, 2025, and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
| SERES THERAPEUTICS, INC. CONSOLIDATED BALANCE SHEETS (unaudited, in thousands, except share and per share data) | ||||||||
| December 31, | ||||||||
| 2024 | 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 30,793 | $ | 127,965 | ||||
| Accounts receivable due from SPN - related party | 2,068 | — | ||||||
| Prepaid expenses and other current assets (1) | 5,813 | 8,049 | ||||||
| Current assets of discontinued operations | — | 39,396 | ||||||
| Total current assets | 38,674 | 175,410 | ||||||
| Property and equipment, net | 11,534 | 17,614 | ||||||
| Operating lease assets | 80,903 | 90,417 | ||||||
| Restricted cash | 8,668 | 8,185 | ||||||
| Restricted investments | — | 1,401 | ||||||
| Other non-current assets | 31 | 2,187 | ||||||
| Non-current assets of discontinued operations (2) | — | 63,386 | ||||||
| Total assets | $ | 139,810 | $ | 358,600 | ||||
| Liabilities and Stockholder's Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,079 | $ | 3,641 | ||||
| Accrued expenses and other current liabilities | 10,719 | 22,509 | ||||||
| Accrued liabilities due to SPN - related party | 17,750 | — | ||||||
| Operating lease liabilities | 8,674 | 5,587 | ||||||
| Current liabilities of discontinued operations (3) | — | 66,922 | ||||||
| Total current liabilities | 41,222 | 98,659 | ||||||
| Long term portion of note payable, net of discount | — | 101,544 | ||||||
| Operating lease liabilities, net of current portion | 82,966 | 91,652 | ||||||
| Warrant liability | — | 546 | ||||||
| Other long-term liabilities | 1,838 | 1,628 | ||||||
| Non-current liabilities of discontinued operations | — | 109,427 | ||||||
| Total liabilities | 126,026 | 403,456 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity (deficit): | ||||||||
| Preferred stock, | — | — | ||||||
| Common stock, | 173 | 135 | ||||||
| Additional paid-in capital | 991,710 | 933,244 | ||||||
| Accumulated deficit | (978,099 | ) | (978,235 | ) | ||||
| Total stockholders’ equity (deficit) | 13,784 | (44,856 | ) | |||||
| Total liabilities and stockholders’ equity | $ | 139,810 | $ | 358,600 | ||||
| [1] Includes [2] Includes [3] Includes related party amounts of | ||||||||
| SERES THERAPEUTICS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) (unaudited, in thousands, except share and per share data) | ||||||||||||
| Year Ended December 31, | ||||||||||||
| 2024 | 2023 | 2022 | ||||||||||
| Operating expenses: | ||||||||||||
| Research and development expenses | $ | 64,600 | $ | 117,597 | $ | 109,651 | ||||||
| General and administrative expenses | 53,183 | 77,500 | 70,263 | |||||||||
| Manufacturing services | 3,532 | — | — | |||||||||
| Total operating expenses | 121,315 | 195,097 | 179,914 | |||||||||
| Loss from operations | (121,315 | ) | (195,097 | ) | (179,914 | ) | ||||||
| Other (expense) income: | ||||||||||||
| Gain on sale of VOWST Business | 5,684 | — | — | |||||||||
| Interest income | 3,967 | 7,301 | 3,058 | |||||||||
| Interest expense | — | (2,468 | ) | (6,020 | ) | |||||||
| Other (expense) income, net | (14,107 | ) | 134 | (705 | ) | |||||||
| Total other (expense) income, net | (4,456 | ) | 4,967 | (3,667 | ) | |||||||
| Net loss from continuing operations | $ | (125,771 | ) | $ | (190,130 | ) | $ | (183,581 | ) | |||
| Net income (loss) from discontinued operations, net of tax | $ | 125,907 | $ | 76,406 | $ | (66,576 | ) | |||||
| Net income (loss) | $ | 136 | $ | (113,724 | ) | $ | (250,157 | ) | ||||
| Net loss from continuing operations per share attributable to common stockholders, basic and diluted | $ | (0.81 | ) | $ | (1.49 | ) | $ | (1.70 | ) | |||
| Net income (loss) from discontinued operations per share attributable to common stockholders, basic and diluted | $ | 0.81 | $ | 0.60 | $ | (0.62 | ) | |||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | 0.00 | $ | (0.89 | ) | $ | (2.31 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 155,400,760 | 128,003,294 | 108,077,043 | |||||||||
| Other comprehensive income: | ||||||||||||
| Unrealized gain on investments, net of tax of | — | 10 | 49 | |||||||||
| Currency translation adjustment | — | 2 | (1 | ) | ||||||||
| Total other comprehensive income | — | 12 | 48 | |||||||||
| Comprehensive income (loss) | $ | 136 | $ | (113,712 | ) | $ | (250,109 | ) | ||||
Investor and Media Contact:
IR@serestherapeutics.com
Carlo Tanzi, Ph.D.
Kendall Investor Relations
ctanzi@kendallir.com
FAQ
What were the key clinical results for Seres' SER-155 in the Phase 1b study?
How much cash does MCRB have and how long will it last?
What is the market size for SER-155 in HSCT procedures?
What was MCRB's net loss from continuing operations in 2024?
When will MCRB submit the next SER-155 study protocol to FDA?
