Seres Therapeutics, Inc. develops live biotherapeutic products and microbiome-based therapies for inflammatory, immune, infectious and gastrointestinal diseases. Company updates commonly address pipeline programs such as SER-155 for immune checkpoint inhibitor-related enterocolitis and prevention of bloodstream infections in allogeneic hematopoietic stem cell transplant patients, SER-603 for inflammatory bowel disease, and SER-428 for antimicrobial resistance and serious infections.
Recurring announcements include financial results, operational updates, research publications, scientific conference presentations, biomarker and microbiome-mechanism data, collaborations, financing and partnership activity, cost-control measures, and governance changes.
Seres Therapeutics (NASDAQ: MCRB) presented at the World Anti-Microbial Resistance Congress on September 7-8, 2022, discussing advancements in microbiome therapeutics to combat antibiotic-resistant bacterial infections. Chief Scientific Officer Dr. Matthew Henn highlighted Phase 3 data showing that SER-109 reduced antibiotic-resistant pathogens. The company also focuses on SER-155, targeting patients undergoing stem cell transplantation. SER-109's Biologics License Application has been filed with the FDA, with a commercial launch expected in early 2023.
Seres Therapeutics (Nasdaq: MCRB) has completed its rolling submission for a Biologics License Application (BLA) to the FDA for SER-109, targeting recurrent C. difficile infections. With FDA Breakthrough Therapy designation, SER-109 could launch in the first half of 2023, aiming to be the first FDA-approved oral microbiome therapeutic. The submission is based on promising Phase 3 trial results showing an 88% sustained response rate compared to 60% for placebo. Seres has partnered with Aimmune Therapeutics for commercialization, receiving an upfront payment of $175 million.
Seres Therapeutics, Inc. (Nasdaq: MCRB), a leader in microbiome therapeutics, announced that CEO Eric Shaff will participate in the Canaccord Genuity 42nd Annual Growth Conference on August 10 at 12:30 p.m. ET. An audio webcast of the event will be accessible on the company's website, with a replay available for 21 days.
Seres is known for its SER-109 program, the first microbiome drug candidate to achieve positive pivotal clinical results, aimed at preventing C. difficile infection recurrences, and is also developing SER-155 to reduce infections in transplant patients.
Seres Therapeutics (MCRB) reported significant progress in its microbiome therapeutic SER-109, with confirmatory Phase 3 study results showing a sustained clinical response in 91.3% of recurrent C. difficile infection patients. The company initiated a rolling Biologics License Application (BLA) submission, expected to be completed soon. Financially, Seres strengthened its position with a $100 million equity offering, bringing its pro-forma cash balance to approximately $291.4 million. Despite a net loss of $64.7 million for Q2 2022, the company remains optimistic about SER-109's commercial potential.
Seres Therapeutics, Inc. (Nasdaq: MCRB) will host a conference call on August 3, 2022 at 8:30 a.m. ET to discuss its second quarter results and provide a business update.
Seres is noted for its SER-109 program, which has achieved significant clinical results in targeting C. difficile infections, receiving both Breakthrough Therapy and Orphan Drug designations from the FDA. The company is also advancing its SER-155 program to reduce infections in patients undergoing stem cell transplants.
Seres Therapeutics (MCRB) announced a registered direct offering of 31,746,030 shares at $3.15 per share, generating approximately $100 million in gross proceeds. The offering, which includes participation from notable investors like Federated Hermes and Nestlé Health Science, is expected to close on July 5, 2022. Proceeds will be used for the commercial readiness and manufacturing of SER-109 for the U.S. market and advancing its clinical development in the EU. The offering is conducted under a shelf registration statement filed with the SEC.
Seres Therapeutics (NASDAQ: MCRB) announced favorable results from the ECOSPOR IV study for SER-109, an oral microbiome therapy for recurrent C. difficile infection. The study showed a 91.3% sustained clinical response at eight weeks and confirmed a favorable safety profile, consistent with the previous ECOSPOR III study. A rolling Biologics License Application (BLA) submission has been initiated, with completion anticipated by mid-2022. The company aims for a potential launch in the first half of 2023, supported by FDA Breakthrough Therapy designation.
Seres Therapeutics, Inc. (MCRB) presented preclinical data highlighting the efficacy of the investigational microbial consortium DE486 in reducing chemotherapy-induced mucositis. The findings will be discussed at the 2022 ASCO Annual Meeting. Additionally, a Phase 1b trial of SER-155 is being conducted to assess its safety and efficacy in preventing complications during stem cell transplants. The company also plans to present Phase III results of SER-109 for recurrent C. difficile infection, which showed a lower recurrence rate than placebo. SER-109 is expected to submit a BLA to the FDA in mid-2022.
Seres Therapeutics, Inc. (Nasdaq: MCRB) presented promising data from its Phase 3 ECOSPOR III study, demonstrating that SER-109 effectively prevents recurrent C. difficile infections by establishing beneficial gut microbes. After one week of treatment, SER-109 increased microbiome diversity, producing fatty acids that inhibit C. difficile growth. The therapy showed an 88% success rate in preventing infection recurrence at eight weeks. Seres aims to submit a Biologics License Application by mid-2022, potentially leading to the first FDA-approved microbiome therapeutic by early 2023.
Seres Therapeutics (Nasdaq: MCRB) announced the presentation of its ECOSPOR III trial data for SER-109 at the Digestive Disease Week (DDW) Annual Meeting, scheduled for May 21-24, 2022. SER-109 is an investigational oral microbiome therapy aimed at preventing recurrent C. difficile infections. The company plans to submit a Biologics License Application (BLA) to the FDA in mid-2022. Presentations include an oral session on SER-109's impact on stool fatty acid metabolites and a poster on its durable engraftment. SER-109 has FDA Breakthrough and Orphan Drug designations.