Microbiome therapeutics company Seres Therapeutics Inc. (MCRB:NASDAQ) Seres Therapeutics Inc. (MCRB:NASDAQ), which is focused on development a consortia of novel multifunctional bacteria that interact with host cells and tissues to treat disease, today announced financial results for the third quarter of 2021 ended September 30, 2021. In addition, the company provided detailed
updates regarding its business operations and clinical pipeline.
Seres Therapeutics' CEO Eric Shaff led off the report by commenting, "We have made considerable progress across our organization, highlighted by the achievement of target enrollment in our investigational SER-109 recurrent C. difficile infection (rCDI) open-label study, and continued preparations for a BLA filing with the U.S. Food and Drug Administration (FDA). Along with our commercialization collaborator Nestlé Health Science and its Aimmune business, our organization continues to prepare for a successful launch of SER-109."
"Recently, we entered into a collaboration with Bacthera A.G., a global leader in biopharmaceutical product manufacturing, that expands our existing capabilities for commercial product supply. We intend to offer, pending approval, the first approved microbiome therapy to individuals living with rCDI, a patient group in urgent need of safe and effective new treatment options," CEO Shaff added.
The company indicated that for Q3/21 it posted total revenue of $126.7 million, compared to $1.4 million in Q3/20. The firm reported that it earned net income of $68.2 million in Q3/21, versus a net loss of $30.3 million during Q3/20.
Seres advised that the increase in net income was primarily attributed to its revenues recognized from its co-commercialization license agreement with Nestlé Health Science.
The company stated that it increased its research and development expenses in Q3/21 to $39.9 million, up from $23.9 million in Q3/20. The firm said this was due to expenses related to its late-stage SER-109 clinical development program and associated manufacturing costs along with additional personnel expenses.
The firm advised that it had about $353.2 million in cash and other liquid securities on its balance sheet as of September 30, 2021.
The company stated that in the Phase 3 ECOSPOR III study of SER-109 in treatment of recurrent C. difficile infection (rCDI), SER-109 successfully met its primary endpoint identified as "superiority to placebo in reducing C. difficile infection recurrence at week 8 in patients with rCDI."
The firm explained that SER-109 is an investigational oral, live microbiome therapeutic that is engineered to prevent recurrences of CDI in patients by modulating the disrupted microbiome to a state that resists C. difficile colonization and growth. The company advise that "the FDA has granted SER-109 Breakthrough Therapy designation and Orphan Drug designation for the treatment of rCDI."
The company stated that it believes that the Phase 3 ECOSPOR III trial's efficacy results should support a BLA filing as a single pivotal study and therefor the company plans to meet with the FDA to begin a rolling submission of the BLA for SER-109 in H1/22.
The company stated that there are about 170,000 rCDI cases reported each year in the U.S. which results in an average of around $34,000 in annual direct healthcare expenses per case. The explained that "CDI causes severe diarrhea and colitis, an inflammation of the colon and has been classified as one of the greatest microbial threats to human health by the Centers for Disease Control and Prevention (CDC)."
The company listed that it entered into agreement with Nestlé Health Science in July 2021, and is partnering with its Aimmune division, to commercialize SER-109 in the U.S. and Canada. The agreement included an upfront license payment of $175 million to Seres and provides for another $125 million if approved by the FDA and in Canada. There are also various sales milestones that if realized could total up to $225 million.
The firm added that it is also preparing to initiate a Phase 1b clinical study of SER-155. The company identified SER-155 as "an investigational oral, rationally-designed, cultivated microbiome therapeutic designed to reduce the incidence of gastrointestinal infections, bacteremia, and graft versus host disease (GvHD) in immunocompromised patients, including patients receiving allogeneic hematopoietic stem cell transplantation (allo-HSCT)."
In a separate news release today, the company together with Bacthera, a specialized contract development and manufacturing organization (CDMO), announced "a collaboration to manufacture SER-109, Seres' lead product candidate for recurrent Clostridioides difficile infection (rCDI)."
For its part, Bacthera will be establishing "a dedicated facility for commercial manufacturing in its new Microbiome Center of Excellence, a manufacturing site dedicated to the production of LBPs located on Lonza's Ibex® campus in Visp, Switzerland."
Bacthera's CEO Lukas Schüpbach remarked, "Bacthera's ambition is to enable our customers such as Seres Therapeutics to bring life-changing treatments to patients by pioneering the Live Biotherapeutic Product industry. With this significant agreement, we are one step closer to making that happen, and we are proud to be part of bringing an entirely new class of medicines to people who have a profound need for it. With our new Microbiome Center of Excellence in Visp, we are looking forward to supporting the manufacturing of potentially life-saving microbiome-based treatments, such as SER-109."
Seres Therapeutics is microbiome therapeutics platform company based in Cambridge, Mass. The firm focuses on developing novel multifunctional bacterial consortia that interact with host cells and tissues for the purpose of treating diseases. Seres claimed that "its SER-109 program achieved the first-ever positive pivotal clinical results for a targeted microbiome drug candidate." In addition to its SER-109 program for treatment of recurrent C. difficile infection, the company is also evaluating its SER-301 in a Phase 1b ulcerative colitis study and its SER-155 in a Phase 1b trial designed to address gastrointestinal infections, bacteremia and graft-versus-host disease.
Seres Therapeutics began the day with a market cap of around $630.1 million with approximately 91.7 million shares outstanding and a short interest of about 9.5%. MCRB shares opened nearly 7% higher today at $7.34 (+$0.47, +6.84%) over yesterday's $6.87 closing price. The stock has traded today between $7.34 and $9.2236 per share and closed for trading at $8.27 (+$1.40, +20.38%).
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