Seres Therapeutics Announces Signing of VOWST™ Asset Purchase Agreement with Nestlé Health Science
Seres Therapeutics (Nasdaq: MCRB) has signed an agreement to sell its VOWST business to Nestlé Health Science. Upon closing, Seres will receive a $175M cash infusion, including an upfront payment, prepaid milestone, and equity investment. Additional $75M in payments are due in 2025, with potential future milestone payments of up to $275M based on VOWST sales targets.
Seres will fully retire its debt and expects to fund operations into Q4 2025. The company will focus on developing next-generation cultivated live biotherapeutic candidates for medically vulnerable populations. The lead program, SER-155, is on track for Phase 1b data in September. The deal is expected to close within 90 days, subject to shareholder approval.
Seres Therapeutics (Nasdaq: MCRB) ha firmato un accordo per vendere la sua attività VOWST a Nestlé Health Science. Al termine della transazione, Seres riceverà un iniezione di liquidità di 175 milioni di dollari, che include un pagamento iniziale, un milestone prepagato e un investimento azionario. Ulteriori pagamenti di 75 milioni di dollari sono previsti per il 2025, con potenziali ulteriori milestone fino a 275 milioni di dollari in base agli obiettivi di vendita di VOWST.
Seres estinguerà completamente il proprio debito e prevede di finanziare le operazioni fino al quarto trimestre del 2025. L'azienda si concentrerà sullo sviluppo di candidati bioterapeutici vivi di nuova generazione coltivati per popolazioni medicalmente vulnerabili. Il programma principale, SER-155, è in fase di preparazione per i dati di Fase 1b a settembre. Si prevede che l'accordo si concluda entro 90 giorni, previa approvazione degli azionisti.
Seres Therapeutics (Nasdaq: MCRB) ha firmado un acuerdo para vender su negocio VOWST a Nestlé Health Science. Al cierre del acuerdo, Seres recibirá una inversión en efectivo de 175 millones de dólares, que incluye un pago inicial, un hito prepagado y una inversión de capital. Se deben realizar pagos adicionales de 75 millones de dólares en 2025, con potenciales pagos futuros de hitos de hasta 275 millones de dólares basados en los objetivos de ventas de VOWST.
Seres liquidará completamente su deuda y espera financiar sus operaciones hasta el cuarto trimestre de 2025. La empresa se enfocará en desarrollar candidatos bioterapéuticos vivos cultivados de próxima generación para poblaciones médicamente vulnerables. El programa principal, SER-155, está en camino de proporcionar datos de Fase 1b en septiembre. Se espera que el acuerdo se cierre en un plazo de 90 días, sujeto a la aprobación de los accionistas.
세레스 테라퓨틱스 (Nasdaq: MCRB)가 네슬레 헬스 사이언스에 VOWST 사업을 매각하기 위한 계약을 체결했습니다. 거래가 종료되면 세레스는 1억 7500만 달러의 현금 투자를 받게 되며, 여기에는 선불 지불, 사전 지급된 마일스톤 및 지분 투자도 포함됩니다. 2025년에 7500만 달러의 추가 지급이 예정되어 있으며, VOWST 판매 목표에 따라 최대 2억 7500만 달러의 잠재적인 추가 마일스톤 지급이 가능합니다.
세레스는 모든 부채를 완전히 상환하고 2025년 4분기까지 운영 자금을 조달할 것으로 예상하고 있습니다. 이 회사는 의학적으로 취약한 인구를 위한 차세대 배양 생물 의약품 후보 개발에 집중할 것입니다. 주요 프로그램인 SER-155는 9월에 1b상 데이터 확보를 목표로 진행되고 있습니다. 계약은 주주 승인을 조건으로 90일 이내에 마감될 것으로 예상됩니다.
Seres Therapeutics (Nasdaq: MCRB) a signé un accord pour vendre son activité VOWST à Nestlé Health Science. À la clôture de l'accord, Seres recevra une injection de liquidités de 175 millions de dollars, comprenant un paiement initial, un jalon prépayé et un investissement en actions. Des paiements supplémentaires de 75 millions de dollars sont dus en 2025, avec des paiements de jalons futurs potentiels allant jusqu'à 275 millions de dollars en fonction des objectifs de vente de VOWST.
Seres éteindra complètement sa dette et s'attend à financer ses opérations jusqu'au quatrième trimestre 2025. L'entreprise se concentrera sur le développement de candidats biothérapeutiques vivants cultivés de nouvelle génération pour des populations médicalement vulnérables. Le programme principal, SER-155, est sur la bonne voie pour obtenir des données de la phase 1b en septembre. L'accord devrait être finalisé dans un délai de 90 jours, sous réserve de l'approbation des actionnaires.
Seres Therapeutics (Nasdaq: MCRB) hat eine Vereinbarung unterzeichnet, um sein VOWST-Geschäft an Nestlé Health Science zu verkaufen. Nach dem Abschluss wird Seres eine Cash-Investition von 175 Millionen Dollar erhalten, einschließlich einer Vorauszahlung, eines vorausbezahlten Meilensteins und einer Beteiligung. Weitere 75 Millionen Dollar an Zahlungen sind für 2025 fällig, mit möglichen zukünftigen Meilensteinzahlungen von bis zu 275 Millionen Dollar basierend auf Verkaufszielen für VOWST.
Seres wird seinen Schuldenstand vollständig tilgen und erwartet, die Geschäftstätigkeiten bis zum vierten Quartal 2025 zu finanzieren. Das Unternehmen konzentriert sich auf die Entwicklung von lebenden biotherapeutischen Kandidaten der nächsten Generation für medizinisch gefährdete Bevölkerungsgruppen. Das Hauptprogramm, SER-155, hat den Zeitplan, im September Daten der Phase 1b bereitzustellen. Der Deal wird innerhalb von 90 Tagen erwartet, vorbehaltlich der Genehmigung durch die Aktionäre.
- Seres to receive $175M cash infusion upon deal closing
- Additional $75M in payments due in 2025
- Potential for up to $275M in future milestone payments based on VOWST sales
- Full retirement of debt obligations
- Expected cash runway extension into Q4 2025
- Focus on developing next-generation cultivated live biotherapeutic candidates
- SER-155 Phase 1b data expected in September
- Sale of VOWST business to Nestlé Health Science
- Workforce reduction by more than one-third following deal closing
Insights
This deal is a significant financial boost for Seres Therapeutics. The
The transaction allows Seres to fully retire its debt, reducing financial risk. The extended cash runway into Q4 2025 gives the company ample time to advance its pipeline, particularly SER-155. However, investors should note the workforce reduction of over one-third, which may impact short-term operations but improve long-term financial efficiency.
Overall, this deal transforms Seres' financial position, allowing them to focus on high-potential areas while reducing debt and extending runway. It's a strategic pivot that could enhance long-term value, albeit with near-term operational adjustments.
This transaction marks a strategic shift for Seres Therapeutics, moving from commercialization to focus on pipeline development. By divesting VOWST, Seres capitalizes on its first FDA-approved product while redirecting resources to promising candidates like SER-155.
The deal leverages Seres' expertise in cultivated live biotherapeutics, applying lessons from VOWST to new indications. Their focus on medically vulnerable populations with compromised microbiomes or immune systems targets high-need, potentially lucrative markets.
Investors should watch the upcoming SER-155 Phase 1b results in September, as positive outcomes could validate Seres' new strategy and potentially lead to partnerships or increased valuation. However, the success of this pivot hinges on clinical results and the company's ability to efficiently develop its pipeline post-restructuring.
This deal reflects growing interest in the microbiome therapeutics market. Nestlé's acquisition of VOWST demonstrates confidence in the commercial potential of FDA-approved microbiome therapies. For Seres, this transaction provides capital to advance next-generation candidates, potentially opening new market opportunities.
The focus on medically vulnerable populations is strategically sound. These patient groups often have treatment options and represent high-value markets. If successful, Seres could capture significant market share in areas like infection prevention in transplant patients or those with chronic liver disease.
However, investors should consider the competitive landscape. As the microbiome field advances, Seres may face increased competition. The company's success will depend on the efficacy of its candidates and its ability to navigate regulatory pathways efficiently, leveraging its experience with VOWST.
Upon closing, Seres to receive
Additional approximately
Seres will fully retire its debt obligations upon closing
Based on existing cash, deal economics and operating plans, Seres expects to fund operations into Q4 2025
Going forward, Seres to focus on improving patient outcomes in medically vulnerable populations with next generation cultivated live biotherapeutic candidates, leveraging established VOWST clinical and regulatory successes
Pipeline led by SER-155; Phase 1b data in the placebo-controlled Cohort 2 study on track for September
CAMBRIDGE, Mass., Aug. 06, 2024 (GLOBE NEWSWIRE) -- Seres Therapeutics, Inc. (Nasdaq: MCRB), (“Seres” or the “Company”), a leading live biotherapeutics company, today announced that it signed an agreement with Société des Produits Nestlé S.A (“Nestlé”) for the sale of its VOWST business to Nestlé Health Science. Upon deal closing, Seres will receive capital infusions, including an upfront payment, a prepaid milestone payment and an equity investment. In addition, Seres is due to receive installment payments in 2025, as well as potential future payments based on VOWST net sales targets. Seres will support ongoing VOWST availability by providing transition services through the first quarter of 2025 and manufacturing support through the end of 2025 (subject to limited extension rights by Nestlé) and will continue to share 50/50 in the profit and loss of the business through the end of 2025. The completion of the transaction, which is subject to Seres’ shareholder approval and other customary conditions, is expected to occur in the next 90 days.
“This transaction provides meaningful capital to support Seres’ pipeline advancement and our focus on improving patient outcomes in medically vulnerable populations through the use of cultivated live biotherapeutics,” said Eric Shaff, President and Chief Executive Officer of Seres. “We are proud of our accomplishments in bringing VOWST to the market as the first ever FDA-approved oral microbiome therapy with an outstanding efficacy and safety profile and now look forward to applying our approach to transform care in new patient groups. As part of the transaction, a number of our talented colleagues will move to Nestlé Health Science – we thank these team members for their contributions to Seres and to developing, manufacturing, and launching VOWST. We also would like to acknowledge Nestlé Health Science as a long-time collaborator and wish them tremendous success as they continue to deliver VOWST to patients and grow the business.”
Mr. Shaff continued, “We will use the capital from this transaction to strengthen our balance sheet, retire our existing debt facility, and advance our pipeline. Our lead SER-155 program remains on track to provide clinical results from the placebo-controlled Cohort 2 segment of the ongoing study in patients receiving allogeneic hematopoietic stem cell transplant (allo-HSCT) in September. SER-155 is designed to prevent gastrointestinal (“GI”)-derived infections and resulting bloodstream infections, as well as induce immune tolerance responses to reduce the incidence of graft-versus-host-disease (GvHD) and, if successful, could profoundly improve patient outcomes. In addition to SER-155, we are developing other cultivated live biotherapeutic candidates for multiple medically vulnerable patient groups, including potentially those with chronic liver disease, cancer neutropenia, and solid organ transplants. Seres’ therapeutic approach could protect these patients from life-threatening infections, thereby creating significant commercial opportunities.”
Deal Terms, Use of Proceeds and Cash Runway
Under the terms of the agreement, Seres is due to receive:
- Payment of
$100M , less approximately$20M in settlement of net obligations payable to Nestlé at closing - Prepayment of a
$60M milestone payment at closing - Installment payments of
$50M in January 2025, and$25M (less up to approximately$1.5M in employment related payments to Nestlé), in July 2025, subject to Seres’ material compliance with transition obligations - Future milestone payments based on VOWST worldwide net sales as follows:
$125M upon achievement of annual worldwide net sales of$400M ; and$150M upon achievement of annual worldwide net sales of$750M
In addition, at the closing, Nestlé will purchase
Seres plans to use the capital from this transaction to fully retire its senior secured debt facility with Oaktree Capital Management and support the further advancement of SER-155 and its other cultivated product candidates.
As various VOWST-related capabilities, including product manufacturing, will transition to Nestlé, the Company expects to reduce its workforce by more than one-third, streamlining its operations and reducing cash burn following the closing of the deal. Based on Seres' current cash, its future operating plans, the capital expected to be obtained from the transaction, and accounting for on-going deal obligations, the Company anticipates its cash runway will extend into Q4 2025.
Future Strategy
Moving forward, Seres will pursue a focused corporate strategy where the Company will apply its experience with cultivated live biotherapeutic candidates, building upon the clinical and regulatory success previously demonstrated with VOWST, to improve patient outcomes in a variety of medically vulnerable populations. Specifically, the Company intends to develop new therapeutics for populations known to harbor disrupted gastrointestinal microbiomes and/or compromised immune systems, who are at high risk of serious, life-threatening bacterial infections that are costly to healthcare systems.
Seres’ lead program, SER-155, is designed to prevent GI-derived infections and resulting bloodstream infections, as well as induce immune tolerance responses in order to reduce the incidence of GvHD in patients undergoing allo-HSCT. Patients undergoing allo-HSCT are at a high risk of life-threatening bacterial infections, providing an opportunity to transform how these patients are managed. SER-155 is currently being evaluated in an ongoing Phase 1b study and the Company anticipates clinical results from a placebo-controlled Cohort 2 group in September.
Conference Call Information
Seres’ management will host a conference call today, August 6, 2024, 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 9125852. 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
The SER-155 composition is designed to prevent gastrointestinal (GI)-derived infections and resulting bloodstream infections, enhance epithelial barrier integrity, and induce immune tolerance responses to reduce the incidence of graft-versus-host-disease (GvHD). SER-155 is being evaluated in a Phase 1b study in patients undergoing allogenic hematopoietic stem cell transplantation (allo-HSCT). SER-155 is a consortium of bacterial species selected and optimized using Seres’ reverse translation discovery and development platform technologies. The design incorporates biomarker data from human clinical data and nonclinical human cell-based assays, and in vivo disease models. SER-155 has received FDA Fast Track Designation.
About Seres Therapeutics
Seres Therapeutics, Inc. (Nasdaq: MCRB) is a commercial-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. The Company is evaluating SER-155 in a Phase 1b study in patients receiving allogeneic hematopoietic stem cell transplantation. SER-155 is designed to prevent gastrointestinal (GI)-derived infections and resulting bloodstream infections, enhance epithelial barrier integrity, and induce immune tolerance responses to reduce the incidence of graft-versus-host-disease (GvHD). The Company is also advancing additional cultivated oral live biotherapeutics for medically vulnerable populations, including those with chronic liver disease, cancer neutropenia, and solid organ transplants. For more information, please visit www.serestherapeutics.com.
Background on Nestlé Health Science Collaboration and VOWST
In July 2021, Seres entered a license agreement with Nestlé Health Science that granted a co-exclusive license to develop and commercialize VOWST. In April 2023, VOWST obtained FDA approval to prevent the recurrence of Clostridioides difficile infection (CDI) in adults following antibacterial treatment for recurrent CDI (rCDI), followed by commercial launch in June 2023 led by Nestlé Health Science. Under the pending agreement, Nestlé Health Science will obtain full ownership of the VOWST business. Seres will support the full transition of VOWST to Nestlé and the continuity of the supply chain through a customary transition service agreement.
Important Additional Information About the Proposed Transaction and Where to Find It
This communication is being made in respect of the proposed transaction involving Seres and Nestlé. Seres expects to seek, and intends to file with the Securities and Exchange Commission (the “SEC”), a proxy statement and other relevant documents in connection with a special meeting of Seres’ stockholders for purposes of obtaining stockholder approval of the proposed transaction. The definitive proxy statement will be sent or given to the stockholders of Seres and will contain important information about the proposed transaction and related matters. INVESTORS AND STOCKHOLDERS OF SERES ARE URGED TO READ THE DEFINITIVE PROXY STATEMENT AND OTHER RELEVANT MATERIALS CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT SERES AND THE PROPOSED TRANSACTION. Investors may obtain a free copy of these materials (when they are available) and other documents filed by Seres with the SEC at the SEC’s website at www.sec.gov or from Seres at its website at ir.serestherapeutics.com.
Participants in the Solicitation
Seres and certain of its directors, executive officers and other members of management and employees may be deemed to be participants in soliciting proxies from its stockholders in connection with the proposed transaction. Information regarding the persons who may, under the rules of the SEC, be considered to be participants in the solicitation of Seres’ stockholders in connection with the proposed transaction will be set forth in Seres’ definitive proxy statement for its stockholder meeting at which the proposed transaction will be submitted for approval by Seres’ stockholders. You may also find additional information about Seres’ directors and executive officers in Seres’ Annual Report on Form 10-K for the fiscal year ended December 31, 2023, which was filed with the SEC on March 5, 2024, and in Seres’ Definitive Proxy Statement for its 2024 annual meeting of stockholders, which was filed with the SEC on March 5, 2024.
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 financial terms, timing and completion of the sale of VOWST assets to Nestlé; the use of proceeds of the transaction, including the ability to retire our senior secured debt facility; the timing and results of our clinical studies; future product candidates, development plans and commercial opportunities; operating plans and our future cash runway; our planned strategic focus and other statements which 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) we have incurred significant losses, are not currently profitable and may never become profitable; (2) our need for additional funding; (3) our history of operating losses; (4) the restrictions in our debt agreement; (5) our novel approach to therapeutic intervention; (6) our reliance on third parties to conduct our clinical trials and manufacture our product candidates; (7) the competition we will face; our ability to protect our intellectual property; (8) our ability to retain key personnel and to manage our growth; (9) the occurrence of any event, change or other circumstance that could give rise to the termination of the Purchase Agreement; (10) our failure to obtain stockholder approval for the proposed transaction or to satisfy any of the other conditions to the completion of the proposed transaction; (11) the effect of the announcement of the proposed transaction on our ability to retain and hire key personnel and maintain relationships with our customers, suppliers, advertisers, partners and others with whom we do business, or on our operating results and businesses generally; (12) the risks associated with the disruption of management’s attention from ongoing business operations due to the proposed transaction and the obligation to provide transition services; (13) our failure to receive the installment payments or the milestone payments in the future; (14) the significant costs, fees and expenses related to the proposed transaction; (15) the uncertainty of impact of the 50/50 profit and loss sharing arrangement on our reported results and liquidity; and (16) the risk that the proposed transaction will not be completed within the expected time period or at all. These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC), on May 8, 2024, 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.
Investor and Media Contacts:
IR@serestherapeutics.com
Carlo Tanzi, Ph.D.
Kendall Investor Relations
ctanzi@kendallir.com
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