Seres Therapeutics price target raised to $46 from $41 at H.C. Wainwright » 06:1505/0505/05/21
H.C. Wainwright analyst…
H.C. Wainwright analyst Vernon Bernardino raised the firm's price target on Seres Therapeutics to $46 from $41 and reiterates a Buy rating on the shares following the company's Q1 results. The analyst expects positive momentum through the second half of 2021.
Seres Therapeutics reports Q1 EPS(39c), consensus (31c) » 07:3905/0405/04/21
Reports Q1 revenue $5.7M,…
Reports Q1 revenue $5.7M, consensus $6.45M. "We continue to make steady progress across our broad microbiome pipeline and we look forward to an eventful remainder of the year with important clinical milestones," said Eric Shaff, President and Chief Executive Officer of Seres. "Our SER-287 ECO-RESET Phase 2b study in mild-to-moderate ulcerative colitis patients is fully enrolled and we anticipate topline clinical results in mid-year. Following successful SER-109 Phase 3 pivotal results in patients with recurrent C. difficile infection, we continue to enroll an open label study to expand our safety database. We are very pleased with the pace of study enrollment and we anticipate achieving target enrollment during the third quarter of 2021. Completion of the required SER-109 safety database will support a Biologics License Application (BLA) filing, and potentially pave the way for SER-109 to become the first-ever FDA-approved microbiome therapeutic."
Kaleido Biosciences reaffirms cash runway into Q1 of 2022 » 07:3505/0405/04/21
As of March 31, 2021, the…
As of March 31, 2021, the company reported cash and cash equivalents of $92.4M. The company continues to manage its operating expenses and, as a result, has cash runway into the first quarter of 2022.
Kaleido Biosciences reports Q1 EPS (58c), consensus (59c) » 07:3505/0405/04/21
Reports Q1 collaboration…
Reports Q1 collaboration revenue $297,000. "Kaleido is off to a strong start in 2021 marked by positive results from our 350-patient clinical study with KB109 in outpatients with mild-to-moderate COVID-19 and a recently completed financing, which will support the continued expansion of our novel, targeted Microbiome Metabolic Therapy candidates," said Dan Menichella, President and CEO of Kaleido. "Consistent with the interim findings we reported earlier this year, results from the full dataset demonstrated that KB109 has a favorable safety and tolerability profile and reduced COVID-19 related healthcare utilization and recovery time in patients with one or more comorbidity. Based on these results, we are investing in the manufacturing of KB109 and are initiating an IND application with the FDA."
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Evelo Biosciences announces expected 2021 milestones » 07:1904/2904/29/21
Upcoming Key Milestones:…
Upcoming Key Milestones: EDP1815 - Psoriasis; all data anticipated to be reported in 3Q 2021; Data from Phase 1b cohorts with tablets and capsules; Full data from Phase 2b dose-ranging trial; EDP1815 - Atopic Dermatitis; Subject to regulatory approval, initiation of Phase 2 trial in 3Q 2021; EDP1815 - COVID-19; While patient accrual for both COVID-19 trials continued during the quarter, given the increase in vaccination rates, and lower number of patients hospitalized with COVID-19 at clinical trial sites, Evelo expects the trials will continue longer than originally planned. The Company is unsure when it will be able to report data, and therefore will no longer be issuing guidance related to these trials. EDP1867 - Atopic Dermatitis; Interim data from Phase 1b trial expected in 4Q 2021; EDP2939 - Inflammation; Initiation of clinical development in 2022; EDP1908 - Oncology; Initiation of clinical development in 2022.
Evelo Biosciences reports Q1 EPS (55c), consensus (51c) » 07:1804/2904/29/21
"Over the past year,…
"Over the past year, we have executed on our research and development plans, providing critical preclinical and clinical data to help inform our late-stage development plans, and further validating our platform. We are poised to continue building on this momentum, with multiple clinical readouts expected across our inflammatory disease portfolio in the next 18 months, including our Phase 2b data from EDP1815 in psoriasis in the third quarter," said Simba Gill, Ph.D., Chief Executive Officer of Evelo. "In order to support this rapid growth, we continue to strengthen our corporate position. We recently expanded our executive team with the addition of Luca Scavo as CFO and Julie H. McHugh to our Board of Directors, and entered into a strategic collaboration with Abdul Latif Jameel Health to potentially provide EDP1815 to the Middle East, Turkey, and Africa, representing a key step in realizing our vision of providing safe, effective, convenient, and affordable medicines to millions of people around the world."
Jefferies to hold a virtual summit » 09:1604/2204/22/21
EVLO, KLDO, MCRB, PHGE, SYRX
Microbiome-Based Therapeutics Virtual Summit will be held on April 22.
Evelo presents data from Phase 1b trial of EDP1815 in atopic dermatitis » 16:0504/2004/20/21
Evelo Biosciences presented full clinical data from the Phase 1b clinical trial cohort evaluating EDP1815 for the treatment of mild and moderate atopic dermatitis in a poster presentation at the International Society of Atopic Dermatitis ,ISAD, Hybrid Meeting 2021. The Company previously reported positive data for all 24 patients in the cohort, which is re-iterated in the presentation, together with new data on the Investigator Global Assessment IGA score. The primary endpoint of the Phase 1b trial was safety and tolerability. As previously disclosed, EDP1815 was well tolerated, with no treatment-related adverse events of moderate or severe intensity and no serious adverse events. The full results reinforce the data released on January 20, 2021, demonstrating that treatment with EDP1815 resulted in clinically meaningful improvements in both patient- and physician-reported outcomes. At the day 70 follow-up visit, 31% more EDP1815-treated patients achieved an IGA score of 0 or 1 greater than placebo. At this same time point, 19% more EDP1815-treated patients reached an IGA score of 0 or 1 with a two-point improvement from baseline greater than placebo. This, in addition to the treatment differences seen within the Eczema Area and Severity Index, SCORing Atopic Dermatitis , and IGA times Body Surface Area clinical endpoints as shown in the image below, suggests the potential of EDP1815 to be an effective, safe, well-tolerated, oral treatment for patients with mild and moderate atopic dermatitis
Kaleido Biosciences announces collaboration with Jenq to explore MMTs » 07:3504/2004/20/21
Kaleido Biosciences announced a research collaboration with researcher Robert Jenq, M.D. Professor of Genomic Medicine, at The University of Texas MD Anderson Cancer Center, to explore the potential of Kaleido's novel Microbiome Metabolic Therapies, or MMT, in preventing febrile neutropenia-a serious complication associated with hematopoietic stem cell transplantations, or HSCT. Within the collaboration, selected MMTs will be evaluated in disease animal models developed by Dr. Jenq, to further explore the molecular mechanisms by which MMTs act on the microbiome and gut barrier function and support the identification of a lead compound from Kaleido's compound library.
Synlogic 10M share Spot Secondary priced at $3.00 » 06:3704/1604/16/21
SVB Leerink acted as sole…
SVB Leerink acted as sole book running manager for the offering.