Seres Therapeutics Announces VOWST™ Commercial Launch Update and US FDA Fast Track Designation for SER-155
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Insights
The preliminary net sales of approximately $10.4 million for VOWST in the fourth quarter of 2023 reflect a significant market entry for Seres Therapeutics. The reported 2,833 patient enrollment forms and 2,015 new patient starts represent a strong initial uptake, suggesting a robust demand for new treatments in the microbiome therapeutics space. This adoption rate is particularly notable given the relatively short period since VOWST's commercial launch in June 2023.
From a market perspective, the collaboration with Nestlé Health Science could provide Seres with an established commercial platform and distribution network, potentially accelerating market penetration and revenue growth. The Fast Track Designation for SER-155 by the FDA signals a recognition of the therapeutic's potential to address unmet medical needs, possibly leading to expedited review and a shorter time to market, subject to successful clinical outcomes.
VOWST's FDA approval for the prevention of Clostridioides difficile infection (CDI) recurrence represents a significant advancement in the management of this condition. CDI is known for its high recurrence rate, which poses a substantial burden on patients and healthcare systems. The therapeutic's broad indication, including use in first recurrence patients, expands its potential patient base. The clinical profile of VOWST, which is the first orally administered microbiome therapeutic approved by the FDA, is likely to be closely monitored by healthcare professionals for its efficacy and safety in real-world settings.
SER-155, aiming to prevent gastrointestinal-associated infections and reduce the incidence of severe acute graft-versus-host disease, addresses critical complications in immunocompromised patients. Its progress through clinical trials and potential future approval could further solidify Seres' position in the market and expand its portfolio of microbiome-based therapies.
The financial implications of VOWST's successful market adoption are promising for Seres Therapeutics' revenue trajectory. The reported preliminary net sales indicate a positive market response, which could lead to upward revisions in revenue forecasts and potentially enhance investor confidence. The strategic partnership with Nestlé Health Science might also play a role in mitigating commercialization risks and improving economies of scale.
Investors will likely monitor the anticipated data readout for SER-155's Phase 1b placebo-controlled Cohort 2 in the third quarter of 2024. Positive results could have a favorable impact on Seres' stock price by validating the company's research and development capabilities and potentially leading to additional funding or partnership opportunities. Conversely, any negative outcomes could adversely affect investor sentiment and the company's valuation.
VOWST preliminary net sales of approximately
Significant adoption of VOWST since commercial launch in June 2023 through year-end 2023 with 2,833 patient enrollment forms received and 2,015 new patient starts
SER-155 Phase 1b placebo-controlled Cohort 2 data readout anticipated in third quarter of 2024
Seres to Present at 42nd Annual J.P. Morgan Healthcare Conference on January 10, 2024
“In 2023, VOWST received FDA approval with a broad indication, which includes use in first recurrence patients. We are thrilled, along with our collaborators at Nestlé Health Science, to help patients exit the vicious cycle of recurrence that happens far too often with CDI,” said Eric Shaff, President and Chief Executive Officer at Seres. “The strong adoption of VOWST since launch is indicative of the high unmet need in this category, the highly compelling clinical profile of VOWST, and the early success we have demonstrated in educating healthcare providers, payers and patients about this new treatment option.”
“Seres is looking forward to 2024 as we continue to build on our initial VOWST commercial success. The SER-155 Cohort-2 readout is expected in the third quarter, and we are excited to announce receipt of Fast Track Designation for SER-155 to reduce the risk of infection and GvHD in allo-HSCT patients. Fast Track Designation is awarded to expedite both drug development and FDA review of drugs to treat serious conditions and fulfill an unmet medical need.”
“I’m pleased with the significant progress made on our launch priorities since the commercial availability of VOWST in June,” said Terri Young, Ph.D., Chief Commercial and Strategy Officer at Seres. “Healthcare provider education efforts have scaled creating a positive customer experience with faster and higher conversion of enrollments to new patient starts. We look forward to continuing our efforts in 2024 with Nestlé Health Science and expect to make significant progress increasing the adoption of VOWST and achieving additional payer coverage.”
Seres will present at the 42nd annual J.P. Morgan Healthcare Conference on Wednesday, January 10, 2024, at 12:45 pm ET / 9:45 am PT. The live presentation and archived webcast will be accessible from the company’s website at www.serestherapeutics.com.
VOWST Commercial Performance
Broad demand for VOWST has been observed across rCDI patients and healthcare providers since product launch in June 2023:
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Fourth quarter net sales were approximately
$10.4 million 11% . Total 2023 net sales since launch in June were approximately$19.6 million 13% .
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Fourth quarter completed prescription enrollment forms received for VOWST were 1,322; of those 1,082 resulted in new patient starts by year-end 2023.
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Total 2023 completed prescription enrollment forms received for VOWST since launch were 2,833; of those 2,015 resulted in new patient starts by year-end 2023.
- In 2023, prescription enrollment forms were submitted by approximately 1,330 unique healthcare providers (HCPs) since launch; approximately 340 HCPs have prescribed VOWST to more than one patient.
Seres 2023 Highlights
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VOWST received FDA approval in April as the first and only FDA approved orally administered microbiome therapeutic to prevent recurrence of CDI in patients with rCDI, after treatment with standard of care antibacterials.
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Strong adoption of VOWST since commercial launch in June 2023 with broad utilization, continued quarter over quarter growth, and significant progress achieving patient access.
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Production of VOWST commercial supply enabled a strong commercial launch within weeks of approval; progress in expansion of VOWST manufacturing capacity.
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SER-155 Phase 1b Cohort 1 clinical data showed favorable tolerability, successful drug bacteria engraftment, and a substantial reduction in pathogen domination in the gastrointestinal microbiome supporting progression to the placebo-controlled Cohort 2.
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SER-155 received US FDA Fast Track Designation.
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Completed strategic restructuring of Company to focus resources and investment on continued VOWST growth, completion of SER-155 Phase 1b study and supporting longer-term business sustainability.
- Named to “TIME 100 Most Influential Companies” list of 100 companies making an extraordinary impact around the world.
Anticipated 2024 Milestones
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Expect continued progress in 2024 towards commercial priorities including:
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Expansion of the number of HCPs prescribing VOWST as a result of new efforts scaled in Q4 2023 such as strengthened promotional campaigns and expanded reach of HCP and patient digital promotion.
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Growth of VOWST utilization earlier in the treatment paradigm including in patients experiencing their first recurrence.
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Maintenance of strong patient access and expansion of payer coverage for VOWST across Commercial and Medicare Part D plans.
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Increasing penetration of the hospital outflow patient segment.
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Expansion of the number of HCPs prescribing VOWST as a result of new efforts scaled in Q4 2023 such as strengthened promotional campaigns and expanded reach of HCP and patient digital promotion.
- SER-155 Phase 1b placebo-controlled Cohort 2 data readout anticipated in third quarter of 2024.
Seres ended 2023 with preliminary cash, cash equivalents and investments of approximately
INDICATION AND IMPORTANT SAFETY INFORMATION FOR VOWST
INDICATION
VOWST is indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI.
Limitation of Use: VOWST is not indicated for treatment of CDI.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Transmissible infectious agents: Because VOWST is manufactured from human fecal matter, it may carry a risk of transmitting infectious agents. Report any infection that is suspected to have been transmitted by VOWST to Aimmune Therapeutics, Inc. at 1-833-246-2566.
Potential presence of food allergens: VOWST may contain food allergens. The potential to cause adverse reactions due to food allergens is unknown.
ADVERSE REACTIONS
The most common adverse reactions (reported in ≥
To report SUSPECTED ADVERSE REACTIONS, contact Aimmune Therapeutics at 1-833-AIM-2KNO (1-833-246-2566), or the FDA at 1-800-FDA-1088, or visit www.fda.gov/MedWatch.
DRUG INTERACTIONS
Do not administer antibacterials concurrently with VOWST.
Please see Full Prescribing Information and Patient Information
About Seres Therapeutics
Seres Therapeutics, Inc. (Nasdaq: MCRB) is a commercial-stage company developing novel microbiome therapeutics for serious diseases. Seres’ lead program, VOWST™, obtained
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 the commercial success and continued growth of VOWST, the timing and results of our clinical studies, access to additional debt tranches, the sufficiency of cash to fund operations, 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: we have incurred significant losses, are not currently profitable and may never become profitable; our need for additional funding; our limited operating history; our novel approach to therapeutic intervention; our reliance on third parties and collaborators to conduct our clinical trials, manufacture our product or product candidates and develop and commercialize our product or product candidates, if approved; the unknown degree and competing factors of market acceptance for VOWST; the competition we will face; our ability to protect our intellectual property; and our ability to retain key personnel and to manage our growth. 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 November 2, 2023, 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.
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Investor and Media:
Rob
Rwindsor@serestherapeutics.com
Source: Seres Therapeutics, Inc.
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