Seres Therapeutics achieves enrollment in ECOSPOR IV trial » 07:2009/1509/15/21
Seres Therapeutics announced it has achieved enrollment of 300 subjects with the ECOSPOR IV open-label study evaluating SER-109, an investigational oral microbiome therapeutic for recurrent C. difficile infection. The target enrollment of a minimum of 300 subjects for the SER-109 safety database was reached in conjunction with a prior completed Phase 3 study, ECOSPOR lll. Seres is required by the FDA to demonstrate safety of SER-109 in at least 300 subjects who have received the dose to be commercialized, consistent with standard FDA guidance, with a 24-week follow-up period, to support a biologics license application submission. Seres plans to close enrollment in the open-label study in the coming weeks and will engage with the FDA on initiation of an expanded access program by the end of the year. Seres intends to seek agreement with the FDA to begin a rolling submission of the BLA for SER-109 in the first half of 2022 and finalize the submission with data from the safety database in mid-2022.
|Over a week ago|
Selecta Biosciences, Cyrus Biotechnology to create therapeutic protein » 08:3109/0809/08/21
Selecta Biosciences and…
Selecta Biosciences and Cyrus Biotechnology, a protein design company, announced a protein engineering collaboration combining Selecta's ImmTOR platform with Cyrus' ability to radically redesign protein therapeutics. The lead program in the collaboration is a proprietary interleukin-2 protein agonist designed to selectively promote expansion of regulatory T cells for the treatment of patients with autoimmune diseases and other deleterious immune conditions. Under the terms of the collaboration, Selecta has provided an upfront payment, and Cyrus is eligible to earn discovery, development and sales based milestones. Novel engineered protein therapeutic candidates from the partnership will be used to expand Selecta's proprietary pipeline and further bolster Selecta's clinically validated ImmTOR platform.
|Over a month ago|
Selecta Biosciences expects cash to fund operations to Q3 of 2023 » 08:1008/1208/12/21
Selecta had $151.5…
Selecta had $151.5 million in cash, cash equivalents, marketable securities, and restricted cash as of June 30, 2021, which compares to cash, cash equivalents, and restricted cash of $149.2M as of March 31, 2021. Selecta believes its available cash, cash equivalents, marketable securities, and restricted cash will be sufficient to meet its operating requirements into the third quarter of 2023.
Selecta Biosciences reports Q2 EPS 0c, consensus (12c) » 08:0808/1208/12/21
Reports Q2 revenue…
Reports Q2 revenue $19.66M, consensus $6.24M. "We are very pleased about our continued progress across all aspects of the company," said Carsten Brunn, Ph.D., president, and chief executive officer of Selecta. "Building on our ongoing empty AAV8 capsid study, we are rapidly advancing our two proprietary gene therapy programs into the clinic and as we enter a critical inflection point in development, we are honored to have gene therapy pioneer, Jude Samulski, Ph.D., join as a special advisor. The recently published preclinical data is encouraging and further supports the advancement of our lead candidate in methylmalonic acidemia, SEL-302. We will build on this momentum and expect to file an IND in MMA during the third quarter of 2021, bringing us one step closer to addressing immunogenicity constraints in AAV-driven gene therapy and ultimately, providing patients with potentially transformative treatment options. Additionally, we are steadily executing across our enzyme and autoimmune development program. We have a well-defined work plan ahead of us and the financial resources to maximize the value of our innovative ImmTOR platform."
Seres Therapeutics price target lowered to $16 from $18 at Oppenheimer » 16:0508/0308/03/21
Oppenheimer analyst Mark…
Oppenheimer analyst Mark Breidenbach lowered the firm's price target on Seres Therapeutics to $16 from $18 and reiterates an Outperform rating on the shares post the Q2 results. Following last month's SER-287 "outright miss," management is prioritizing completion of the ECOSPOR IV study of SER-109 to satisfy the FDA's safety database requirements and support a potential application filing in 2022, Breidenbach tells investors in a research note. The analyst views the 66% selloff following SER-287's failure as a market overreaction and says the commercial potential of SER-109 is not fairly reflected by the current share price.
Seres Therapeutics reports Q2 EPS (53c), consensus (37c) » 07:5308/0308/03/21
Reports Q2 revenue…
Reports Q2 revenue $5.26M, consensus $5.34M. "We have made strong progress advancing SER-109, which we expect will become the first-ever FDA-approved microbiome therapeutic. We are nearing target enrollment in our open-label safety study and preparing to file a Biologics License Application (BLA) to support SER-109 product approval. In addition, we recently entered into a license agreement with Nestle Health Science to co-commercialize SER-109 in North America, which we believe will most effectively bring SER-109 to patients suffering from recurrent CDI. Furthermore, this transaction provides Seres with substantial capital to extend our leadership position in the development of our platform technologies and pipeline of microbiome therapeutics, including SER-301 and SER-155, as well as our preclinical stage programs," said Eric Shaff, president and CEO of Seres. "Earlier this month we announced topline clinical results from our SER-287 donor-derived investigational microbiome candidate Phase 2b study in ulcerative colitis. We look forward to learning more about this trial from the microbiome results anticipated during the second half of this year, and we expect these scientific data to inform both the continued advancement of our microbiome therapeutic approach in UC and future development candidates more broadly."
Selecta Biosciences appoints Jude Samulski as gene therapy special advisor » 08:0607/2607/26/21
Selecta Biosciences announced the appointment of Jude Samulski, Ph.D., as a special advisor to assist with the development of their gene therapy programs. Additionally, Selecta has published a peer-reviewed online article describing pre-clinical data from its study investigating the efficacy of co-administration of ImmTOR nanoparticles with AAV vectors in transgene expression in methylmalonic acidemia in the journal Molecular Therapy Methods & Clinical Development. The publication, entitled, "ImmTOR nanoparticles enhance AAV-driven transgene expression after initial and repeat dosing in a mouse model of methylmalonic acidemia," was led by Petr Ilyinskii, Ph.D., a senior director at Selecta. Dr. Samulski is professor of pharmacology and has been the director of the University of North Carolina Gene Therapy Center for over two decades. In the study, performed in collaboration with the National Human Genome Research Institute, researchers evaluated the therapeutic efficacy of co-administration of ImmTOR and an AAV vector in a mouse model of MMA. After the initial dose, immediate increases in transgene expression and reduction of plasma methylmalonic acid, a marker of therapeutic activity, were observed in mice treated with both ImmTOR and AAV. Repeated administration of AAV vectors enabled by ImmTOR resulted in increased vector transduction and further decreases in plasma methylmalonic acid that was dose dependent. The combination was well-tolerated and led to near complete inhibition of neutralizing antibodies to the AAV vector. These data support the use of ImmTOR in combination with AAV-driven gene therapy to mitigate the current detrimental impacts of immunogenicity to AAV, potentially enabling re-dosing and elevated transgene expression at the initial dose.
Fly Intel: Top five analyst downgrades » 09:5507/2307/23/21
MCRB, SAM, DPZ, LPRO, ADVM
Catch up on today's…
Catch up on today's top five analyst downgrades with this list compiled by The Fly: 1. Seres Therapeutics (MCRB) downgraded to Sell from Neutral at Goldman Sachs with analyst Chris Shibutani saying "disappointing" top line results for the company's SER-287 Phase 2b ECO-RESET study prompts the analyst to remove projections for the asset from the model. 2. Boston Beer (SAM) downgraded to Neutral from Buy at Goldman Sachs with analyst Bonnie Herzog saying the analyst is "very surprised by the magnitude of this quarter's miss," which she says came in well below expectations despite management's "consistently confident tone" as recently as May 18. 3. Domino's Pizza (DPZ) downgraded to Neutral from Overweight at JPMorgan with analyst John Ivankoe citing valuation for the downgrade, saying the current share price is "just too high." 4. Open Lending (LPRO) downgraded to Neutral from Buy at Goldman Sachs with analyst Matthew O'Neill citing valuation for the following the stock's recent outperformance. 5. Adverum Biotechnologies (ADVM) downgraded to Neutral from Buy at Goldman Sachs with analyst Graig Suvannavejh saying the news of additional cases of hypotony "comes as a disappointment," but the formal discontinuation of the company's efforts to further expand the potential utility of ADVM-022 beyond the initial wet AMD indication and into DME "does not come as a surprise" given that he previously removed a potential revenue contribution from the DME indication on the initial news of the SUSAR. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
Monster Beverage, Starbucks upgrades among today's top Wall Street calls » 09:4007/2307/23/21
MNST, SBUX, MCRB, DPZ, NKE
Check out today's top…
Seres Therapeutics price target lowered to $18 from $36 at Oppenheimer » 07:4007/2307/23/21
Oppenheimer analyst Mark…
Oppenheimer analyst Mark Breidenbach lowered the firm's price target on Seres Therapeutics to $18 from $36 and keeps an Outperform rating on the shares after the Phase 2b ECO-RESET study of SER-287 missed its primary endpoint and the treatment showed no improvement in clinical remission rate vs. placebo. Despite this setback, Breidenbach sees Seres shares as undervalued given the commercial potential of the company's pipeline, the analyst tells investors in a research note.