Seres Therapeutics, Inc.

Previous wording

All shares of our common stock, stock-based instruments, and per-share data included in this Quarterly Report on Form 10-Q have been retroactively adjusted as though the reverse stock split had been effected prior to all periods presented.

Current wording

On April 21, 2025, we effected a 1-for-20 reverse stock split of our common stock. All shares of our common stock, stock-based instruments, and per-share data included in this Quarterly Report on Form 10-Q have been retroactively adjusted as though the reverse stock split had been effected prior to all periods presented.

Previous wording

We are a clinical-stage company focused on improving patient outcomes in medically vulnerable populations through discovery and development of novel live biotherapeutic product, or LBP, candidates. We led the successful development and approval of VOWST, the first FDA-approved orally administered microbiome biotherapeutic and a Breakthrough Therapy designated drug, which was sold to Société des Produits Nestlé S.A., or SPN, and with certain of its affiliates, collectively, Nestlé Health Science, in September 2024. We have established field-leading capabilities and platforms that are powered by best-in-field human data sets to advance a portfolio of products that can uniquely address diseases by targeting host pathways that are modulated by microbes in the human body, and, in particular, diseases associated with mucosal barrier-immune interface targets. We believe clinical and nonclinical data across our programs support the development of LBPs to target the prevention and treatment of a broad swath of infections, and to treat inflammatory and immune, or I&I, diseases. Our pipeline consists of SER-155, SER-603, SER-428, and SER-147, as well as other potential candidates in earlier development.

Current wording

We are a clinical-stage company focused on improving patient outcomes in medically compromised populations, including oncology patients and those suffering from inflammatory and immune, or I&I, diseases through discovery and development of novel live biotherapeutic product, or LBP, candidates. We led the successful development and approval of VOWST, the first FDA-approved orally administered microbiome biotherapeutic and a Breakthrough Therapy designated drug, which was sold to Société des Produits Nestlé S.A., or SPN, and with certain of its affiliates, collectively, Nestlé Health Science, in September 2024. We have established field-leading capabilities and platforms that are powered by best-in-field human data sets to advance a portfolio of products that can uniquely address diseases by targeting host pathways that are modulated by microbes in the human body, and, in particular, diseases associated with mucosal epithelial barrier-immune interface targets. We believe clinical and nonclinical data across our programs support the development of LBPs to address unmet medical needs in oncology that can lead to interruption to patients' cancer treatment and/or mortality (by targeting the prevention and treatment of a broad swath of infection risks faced by cancer patients and by treating irEC), and to treat I&I diseases. Our pipeline consists of SER-155, SER-603, SER-428, and SER-147, as well as other potential candidates in earlier development.

Previous wording

We are designing LBP candidates to modulate host function to increase epithelium integrity and to induce immune homeostasis and tolerance, as well as to prevent the colonization and overgrowth of pathogens in the gastrointestinal, or GI, tract. We believe that the scientific and clinical data from the development of VOWST (our then product candidate SER-109 program) and the data from the SER-155 Phase 1b study in allo-HSCT (described below) validate our novel therapeutic approach in both infectious disease and I&I diseases. In the context of infection, we believe that our technology may be replicable across different bacterial pathogens with the potential to develop live biotherapeutics to protect a range of medically compromised patients at risk of antimicrobial resistance, or AMR, infections and bloodstream infections, or BSIs, that can result from a compromised epithelial barrier and that can be a major cause of mortality.

Current wording

We are designing LBP candidates to modulate host function to protect and improve mucosal epithelial barrier integrity, induce immune homeostasis and tolerance, and prevent the colonization and overgrowth of pathogens in the gastrointestinal, or GI, tract. We believe that the scientific and clinical data from the development of VOWST (our then product candidate SER-109 program) and the data from the SER-155 Phase 1b study in allo-HCT and the SER-155 IST in irEC (both further described below) validate our novel therapeutic approach to address unmet medical needs in oncology that can lead to interruption to patients' cancer treatment and/or mortality, and to treat I&I diseases.

Previous wording

SER-155, our most advanced LBP candidate, is an investigational, oral, live biotherapeutic designed to decolonize GI pathogens, improve GI epithelial barrier integrity, and induce immune homeostasis to prevent bacterial BSIs, including those that can harbor antimicrobial resistance, as well as other pathogen-associated negative clinical outcomes in patients undergoing allogeneic hematopoietic stem cell transplantation, or allo-HSCT. In our placebo-controlled Phase 1b study of SER-155 in allo-HSCT, SER-155 was associated with a 77% relative risk reduction in bacterial BSIs and a significant reduction in systemic antibiotic exposure as well as a lower incidence of febrile neutropenia, as compared to placebo through day 100 post HSCT. SER-155 was generally well tolerated, with no observed treatment-related serious adverse events. Following advancement of key startup activities for the SER-155 Phase 2 study in allo-HSCT, including the submission of a final protocol to the FDA in January 2026, study site evaluation and qualification with our CRO, and manufacturing of drug substance, we have paused additional investment in that program while continuing to seek funding for the Phase 2 study.

Current wording

In the context of preventing infection for patients undergoing allo-HCT for hematological cancer, we believe that our technology may be replicable across different bacterial pathogens with the potential to develop live biotherapeutics to protect a range of medically compromised patients at risk of antimicrobial resistance, or AMR, infections and bloodstream infections, or BSIs, that can result from a compromised mucosal epithelial barrier and that can be a major cause of mortality. SER-155, our most advanced LBP candidate, is an investigational, oral, live biotherapeutic designed to decolonize GI pathogens, improve GI mucosal epithelial barrier integrity, and induce immune homeostasis to prevent bacterial BSIs, including those that can harbor antimicrobial resistance, as well as other pathogen-associated negative clinical outcomes in patients undergoing allogeneic hematopoietic stem cell transplantation, or allo-HCT. In our placebo-controlled Phase 1b study of SER-155 in allo-HCT, SER-155 was associated with a 77% relative risk reduction in bacterial BSIs and a significant reduction in systemic antibiotic exposure as well as a lower incidence of febrile neutropenia, as compared to placebo through day 100 post HCT. SER-155 was generally well tolerated, with no observed treatment-related serious adverse events. Drug pharmacology data demonstrated that SER-155 significantly promoted mucosal epithelial barrier integrity and had a positive impact on biomarkers of systemic inflammation and immune homeostasis. Following advancement of key startup activities for the SER-155 Phase 2 study in allo-HCT, including the submission of a final protocol to the FDA in January 2026, study site evaluation and qualification with our CRO, and manufacturing of drug substance, we have paused additional investment in that program while continuing to seek funding for the Phase 2 study.

Previous wording

Our current strategy prioritizes advancing our programs that target I&I indications. We have meaningfully advanced over the past decade our scientific understanding of how microbes in the GI functionally modulate pathways at the mucosal barrier-immune interface that are associated with inflammatory and immune-related disease. The clinical data from our SER-155 Phase 1b study in allo-HSCT, along with our extensive preclinical and translational clinical data compiled over the past decade support and inform the advancement of our earlier stage programs targeting I&I diseases. We are evaluating SER-155 in immune checkpoint-related enterocolitis, or irEC, through an investigator-sponsored trial, or IST, with Memorial Sloan Kettering Cancer Center, an institution with whom we have had a decade-long collaboration. irEC is among the most frequent and severe immune-related adverse events, or irAEs, in recipients of immune checkpoint inhibitor, or ICI, therapy and can be observed in up to 50% of patients, with rates varying based on cancer drug and treatment regimen. ICIs can cause a wide range of irAEs with links to T cell biology and epithelial barrier inflammation, both of which are biological functions shown in our preclinical and clinical pharmacology data to be positively impacted by SER-155. We expect to report initial clinical results, including preliminary safety, efficacy, pharmacology, and exploratory biomarker data in the coming weeks. We believe data from this IST could further support the potential for live biotherapeutics to address a significant unmet need among the large population of cancer patients receiving ICIs and may further support evaluation of our biotherapeutic approach in this setting. We are also developing SER-603, broadly in inflammatory bowel disease, or IBD, including ulcerative colitis, or UC, and Crohn's disease. SER-603 is a novel, LBP candidate optimized to address disruptions in the GI microbiome and to improve GI mucosal barrier integrity through the inhibition of inflammatory bacteria and associated metabolites, the promotion of epithelial barrier integrity to reduce the translocation of inflammatory molecules and barrier inflammation, and to induce immune homeostasis through non-immunosuppressive regulatory T cell, or T-reg, induction via T cell signaling. We believe that our LBPs could represent a non-immunosuppressive treatment option for I&I diseases that are linked to colitis and could broadly address immune therapy toxicities, both of which represent significant unmet medical needs and potential commercial opportunities. We are currently exploring potential collaborations related to those I&I disease programs.

Current wording

We have meaningfully advanced over the past decade our scientific understanding of how microbes in the GI functionally modulate pathways at the mucosal epithelial barrier-immune interface that are associated with inflammatory and immune-related disease. The clinical data from our SER-155 Phase 1b study in allo-HCT and the IST in irEC, in particular the drug pharmacology translational biomarker data, along with our extensive preclinical and translational clinical data compiled over the past decade support and inform the advancement of our earlier stage programs targeting I&I diseases and our current strategy continues to prioritize these indications. We are developing SER-603, broadly in inflammatory bowel disease, or IBD, including ulcerative colitis, or UC, and Crohn's disease. SER-603 is a novel, LBP candidate optimized to address disruptions in the GI microbiome and to improve GI mucosal epithelial barrier integrity through the inhibition of inflammatory bacteria and associated metabolites, the promotion of epithelial barrier integrity to reduce the translocation of inflammatory molecules and barrier inflammation, and to induce immune homeostasis through non-immunosuppressive regulatory T cell, or T-reg, induction via T cell signaling. We believe that our LBPs could represent a non-immunosuppressive treatment option for I&I diseases that are linked to colitis and could broadly address immune therapy toxicities, both of which represent significant unmet medical needs and potential commercial opportunities. We are currently exploring potential collaborations related to those I&I disease programs.

Previous wording

We believe that SER-155 and other cultivated live biotherapeutic candidates could be developed in additional patient populations to address barrier compromise and bloodstream and AMR infections beyond allo-HSCT, including autologous-HSCT patients, cancer patients with neutropenia, chimeric antigen receptors therapy, or CAR-T, recipients, individuals with chronic liver disease, or CLD, solid organ transplant recipients, as well as patients in the intensive care unit, or ICU, and long-term acute care facilities. In 2025, we received a non-dilutive award from CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) for up to $3.6 million, representing our second CARB-X award, to support the development of an oral liquid formulation based on SER-155 strains, now referred to as SER-428, for dosing in patients who cannot take oral capsules such as intubated patients in the medical ICU, and other medically vulnerable patients at high risk of AMR infections. We have advanced development and manufacturing of SER-428 and are designing a Phase 1b open label trial in collaboration with Columbia University to evaluate this LBP candidate in medical ICU patients at high risk of infection. Additionally, we continue to develop another proprietary live biotherapeutic composition, SER-147, designed to prevent bacterial bloodstream and spontaneous bacterial peritonitis, or SBP, infections in patients with metabolic disease, including CLD. We continue to leverage microbiome pharmacokinetic and pharmacodynamic data from across our clinical and preclinical portfolios, using our reverse translational development platform to prioritize future drug targets and to identify opportunities for monotherapy treatment and in combination with existing therapies across various indications, including inflammatory and immune diseases, cancer, and metabolic diseases.

Current wording

We believe that SER-155 and other cultivated live biotherapeutic candidates could be developed in additional patient populations in which mucosal epithelial barrier compromise is implicated. For example, in bloodstream and AMR infections, there are numerous medically compromised patients beyond allo-HCT, including autologous-HCT patients, cancer patients with neutropenia, chimeric antigen receptors therapy, or CAR-T, recipients, individuals with chronic liver disease, or CLD, solid organ transplant recipients, as well as patients in the intensive care unit, or ICU, and long-term acute care facilities. In 2025, we received a non-dilutive award from CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) for up to $3.6 million, representing our second CARB-X award, to support the development of an oral liquid formulation based on SER-155 strains, now referred to as SER-428, for dosing in patients who cannot take oral capsules such as intubated patients in the medical ICU, and other medically vulnerable patients at high risk of AMR infections. We have advanced development and manufacturing of SER-428 and are designing a Phase 1b open label trial in collaboration with Columbia University to evaluate this LBP candidate in medical ICU patients at high risk of infection. Additionally, we continue to develop another proprietary live biotherapeutic composition, SER-147, designed to prevent bacterial bloodstream and spontaneous bacterial peritonitis, or SBP, infections in patients with metabolic disease, including CLD. We continue to leverage microbiome pharmacokinetic and pharmacodynamic data from across our clinical and preclinical portfolios, using our reverse translational development platform to prioritize future drug targets and to identify opportunities for monotherapy treatment and in combination with existing therapies across various indications, including inflammatory and immune diseases, cancer, and metabolic diseases.

Previous wording

Our product candidates are in early-stage clinical or preclinical development. Our ability to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our product candidates. Since our inception, we have incurred significant operating losses. Our net loss was $19.9 million for the three months ended March 31, 2026. As of March 31, 2026, we had an accumulated deficit of $992.3 million.

Current wording

Our product candidates are in early-stage clinical or preclinical development. Our ability to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our product candidates. Since our inception, we have incurred significant operating losses. Our net loss from operations was $42.2 million for the six months ended June 30, 2026. As of June 30, 2026, we had an accumulated deficit of $987.7 million.

Previous wording

While we plan to focus our investment on advancing our early-stage live biotherapeutic candidates, starting with SER-603, in the near-term, and, subject to receiving additional funding, progressing the development of SER-155 into a Phase 2 study in allo-HSCT, our expenses may increase in connection with these future activities. See “Risk Factors—Risks Related to Our Financial Position and Need for Additional Capital—We are a clinical-stage company and have incurred significant losses since our inception. We expect to incur losses for the foreseeable future and may never achieve or maintain profitability.”

Current wording

We plan to focus our investment in the near-term on advancing our early-stage live biotherapeutic candidates, including advancing IND-enabling studies for SER-603, evaluating the next stage of development for SER-155 in irEC, and, subject to receiving additional funding, progressing the development of SER-155 into a Phase 2 study in allo-HCT. Our expenses may increase in connection with these future activities. See “Risk Factors—Risks Related to Our Financial Position and Need for Additional Capital—We are a clinical-stage company and have incurred significant losses since our inception. We expect to incur losses for the foreseeable future and may never achieve or maintain profitability.”

Previous wording

As of March 31, 2026, we had cash and cash equivalents totaling $29.8 million. Based on our currently available cash resources, and considering our future operating plans, we anticipate that we will require additional funding following the third quarter of 2026. In accordance with applicable accounting standards, we evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within 12 months after the date of the issuance of the condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q. In performing this analysis, we excluded certain elements of our operating plan that cannot be considered probable of occurring. Under the applicable accounting standards, any future transactions or equity issuances cannot be considered probable, as these events are outside our control. Accordingly, management has concluded that substantial doubt exists about our ability to continue as a going concern for 12 months from the date the condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q are issued. See “Risk Factors— Risks Related to Our Financial Position and Need for Additional Capital —We have identified conditions and events that raise substantial doubt regarding our ability to continue as a going concern.”

Current wording

As of June 30, 2026, we had cash and cash equivalents totaling $15.6 million. Based on our currently available cash resources, the $12.5 million Milestone Termination Payment received from SPN in July 2026, and the expected receipt of the additional $12.5 million Milestone Termination Payment due from SPN in October 2026, and considering our future operating plans, we anticipate that we will require additional funding following the first quarter of 2027. In accordance with applicable accounting standards, we evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within 12 months after the date of the issuance of the condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q. In performing this analysis, we excluded certain elements of our operating plan that cannot be considered probable of occurring. Under the applicable accounting standards, any future transactions or equity issuances cannot be considered probable, as these events are outside our control. Accordingly, management has concluded that substantial doubt exists about our ability to continue as a going concern for 12 months from the date the condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q are issued. See “Risk Factors— Risks Related to Our Financial Position and Need for Additional Capital —We have identified conditions and events that raise substantial doubt regarding our ability to continue as a going concern.”

Previous wording

On February 12, 2026, we announced that we implemented cost reduction actions, including reducing our workforce by approximately 30%. During the three months ended March 31, 2026, we incurred approximately $0.9 million in restructuring costs, primarily related to severance costs, of which $0.7 million was paid as of March 31, 2026. The remainder of these costs are expected to be paid out by the second quarter of 2026.

Current wording

On February 12, 2026, we announced that we implemented cost reduction actions, including reducing our workforce by approximately 30%. During the three months ended March 31, 2026, we incurred approximately $0.9 million in restructuring costs, primarily related to severance costs, of which $0.7 million was paid during the first quarter of 2026, and the remainder was paid out in the second quarter of 2026.

Previous wording

Immune checkpoint-related enterocolitis (irEC)

Current wording

Treatment of Immune checkpoint-related enterocolitis (irEC)

Previous wording

We have been collaborating with Memorial Sloan Kettering Cancer Center for over a decade on the impact of the GI microbiome on immune related diseases and cancer; recently this long-standing collaboration included an investigator-sponsored trial, or IST, evaluating SER-155 in 15 participants with irEC. irEC is among the most frequent and severe immune-related adverse events, or irAEs, in recipients of immune checkpoint inhibitor, or ICI, therapy and can be observed in up to 50% of patients, with rates varying based on cancer drug and treatment regimen. ICIs can cause a wide range of irAEs with links to T cell biology and epithelial barrier inflammation, both of which are biological functions shown in our preclinical and clinical pharmacology data to be positively impacted by SER-155. The program is designed to promote mucosal healing and modulate inflammation without systemic immunosuppression, with the goal of reducing or eliminating the need for high-dose corticosteroids, which carry the risk of toxicity and ICI efficacy impact. We believe SER-155 could be a first-in-class therapy; current approaches manage toxicity reactively with immunosuppression, which can negatively impact cancer treatment.

Current wording

We have been collaborating with Memorial Sloan Kettering Cancer Center for over a decade on the impact of the GI microbiome on immune related diseases and cancer; recently this long-standing collaboration included a single arm, open-label Phase 1b investigator-sponsored trial, or IST, evaluating SER-155 as a potential first-line treatment in irEC. The study evaluated SER-155 in 15 patients with moderate-to-severe (Grade 2- 3) irEC. irEC is among the most frequent and severe immune-related adverse events, or irAEs, in recipients of immune checkpoint inhibitor, or ICI, therapy and can be observed in up to 50% of patients, with rates varying based on cancer drug and treatment regimen. Moderate to severe irEC occurs in approximately 25% of all ICI therapy recipients in the United States. ICIs can cause a wide range of irAEs with links to T cell biology and epithelial barrier inflammation, both of which are biological functions shown in our preclinical and clinical pharmacology data to be positively impacted by SER-155. Participants in the study were on a wide range of ICI types, including PD-1 inhibitors (Keytruda®, Opdivo®, Zynyz®), PD-L1 inhibitors (Imfinzi®, Bavencio®), CTLA-4 inhibitors (Yervoy®, Imjudo®), LAG-3 inhibitor (Opdualag®), and combinations thereof. Clinical guidelines for these patients who experience Grade 2-3 irEC stipulate halting of ICI cancer treatment and initiation of systemic immunosuppressive corticosteroids, which are associated with clinically meaningful toxicities and other negative consequences, including systemic immunosuppression, increased infection risk, metabolic complications, and potential interference with cancer treatment. There remains a significant unmet need for systemic, immunosuppressive-free therapeutic approaches that reduce gastrointestinal inflammation and diarrhea and may allow patients who develop irEC to avoid disruption of their life-saving ICI cancer treatment. SER-155 is designed to promote mucosal healing and modulate inflammation without systemic immunosuppressives, which carry the risk of toxicity and ICI efficacy impact.

Previous wording

We continue to be invested in the infectious disease space, with a renewed focus on leveraging our existing clinical data, translational insights, and manufacturing capabilities to support targeted development efforts across a defined set of related indications. We believe that the scientific and clinical data from our VOWST program (our then product candidate SER-109 program) validate our novel approach of using live biotherapeutics to decolonize pathogens and improve epithelial barrier integrity, resulting in reduced rate of infections in medically compromised patients. Data from the ECOSPOR III and ECOSPOR IV Phase 3 trial published in the New England Journal of Medicine (Feuerstadt et al., 2022) and Journal of the American Medical Association(Sims et al., 2023) suggest that live biotherapeutics have the potential to restructure the gut microbiome and shift the gut metabolic landscape. Additional data show that VOWST rapidly reduced the abundance of bacteria associated with common antibiotic resistance genes, or ARGs, and reduced ARG abundance in the gut (Straub et al., 2023). Collectively, we believe these data suggest the potential for live biotherapeutics to prevent the colonization and overgrowth of pathogens that can establish in the gut and ultimately to reduce infections. We believe that reducing pathogen colonization in the GI and improving GI epithelial barrier integrity to reduce the risk of infection may be replicable in a range of medically compromised patients, protecting them from infections and resulting downstream clinical sequelae.

Current wording

Oncology patients are particularly vulnerable to risk of infection due to their cancer treatment and conditioning procedure as well as compromised immune system. We believe that the scientific and clinical data from our VOWST program (our then product candidate SER-109 program) validate our novel approach of using live biotherapeutics to decolonize pathogens and improve mucosal epithelial barrier integrity, resulting in reduced rate of infections in medically compromised patients. Data from the ECOSPOR III and ECOSPOR IV Phase 3 trial published in the New England Journal of Medicine (Feuerstadt et al., 2022) and Journal of the American Medical Association(Sims et al., 2023) suggest that live biotherapeutics have the potential to restructure the gut microbiome and shift the gut metabolic landscape. Additional data show that VOWST rapidly reduced the abundance of bacteria associated with common antibiotic resistance genes, or ARGs, and reduced ARG abundance in the gut (Straub et al., 2023). Collectively, we believe these data suggest the potential for live biotherapeutics to prevent the colonization and overgrowth of pathogens that can establish in the gut and ultimately to reduce infections. We believe that reducing pathogen colonization in the GI and improving GI epithelial barrier integrity to reduce the risk of infection may be replicable in a range of medically compromised patients, protecting them from infections and resulting downstream clinical sequelae.

Previous wording

We are developing SER-155, an investigational, oral, live biotherapeutic designed to decolonize GI pathogens, improve GI epithelial barrier integrity, and induce immune homeostasis to prevent bacterial BSIs, including those that can harbor AMR, as well as other pathogen associated negative clinical outcomes in patients undergoing allo-HSCT. SER-155 is a live biotherapeutic candidate designed to prevent frequent, expensive, and fatal infections in blood cancer patients.

Current wording

We are developing SER-155, an investigational, oral, live biotherapeutic designed to decolonize GI pathogens, improve GI epithelial barrier integrity, and induce immune homeostasis to prevent bacterial BSIs, including those that can harbor AMR, as well as other pathogen associated negative clinical outcomes in patients undergoing allo-HCT. SER-155 is a live biotherapeutic candidate designed to prevent frequent, expensive, and fatal infections in blood cancer patients.

Previous wording

The rationale for this program is based in part on published clinical evidence from our collaborators at Memorial Sloan Kettering Cancer Center showing that allo-HSCT patients with decreased diversity of commensal microbes and pathogen domination in the gastrointestinal tract were significantly more likely to die due to infection and/or lethal GvHD (Peled et al., 2020). There are an estimated 40,000 allo-HSCT procedures annually worldwide, and infection is one of the most common causes of mortality in these patients. The Center for International Blood & Marrow Transplant Research, or CIBMTR, reports that 19-28% of deaths in allo-HSCT patients over 18 years of age within 100 days post-transplant are caused by infections and 5-14% by GvHD. In December 2023, we received Fast Track Designation for SER-155 to reduce the risk of infection and GvHD in allo-HSCT patients. In December 2024, the FDA granted Breakthrough Therapy designation to SER-155 for the reduction of BSIs in patients 18 years and older undergoing allo-HSCT.

Current wording

The rationale for this program is based in part on published clinical evidence from our collaborators at Memorial Sloan Kettering Cancer Center showing that allo-HCT patients with decreased diversity of commensal microbes and pathogen domination in the gastrointestinal tract were significantly more likely to die due to infection and/or lethal GvHD (Peled et al., 2020). There are an estimated 40,000 allo-HCT procedures annually worldwide, and infection is one of the most common causes of mortality in these patients. The Center for International Blood & Marrow Transplant Research, or CIBMTR, reports that 19-28% of deaths in allo-HCT patients over 18 years of age within 100 days post-transplant are caused by infections and 5-14% by GvHD. In December 2023, we received Fast Track Designation for SER-155 to reduce the risk of infection and GvHD in allo-HCT patients. In December 2024, the FDA granted Breakthrough Therapy designation to SER-155 for the reduction of BSIs in patients 18 years and older undergoing allo-HCT.

Previous wording

SER-155 has been evaluated in a Phase 1b study in patients undergoing allo-HSCT. The SER-155 Phase 1b study included two cohorts. Cohort 1 was designed to assess safety and drug pharmacology, specifically the drug strain engraftment in the gastrointestinal tract. Cohort 1 included 13 subjects who received any dosing of the SER-155 regimen, with 11 subjects subsequently receiving an allo-HSCT. Results from this cohort, announced in May 2023, showed SER-155 was generally well tolerated and resulted in successful drug strain engraftment and a reduction in pathogen domination in the GI microbiome relative to a historical control cohort.

Current wording

SER-155 has been evaluated in a Phase 1b study in patients undergoing allo-HCT. The SER-155 Phase 1b study included two cohorts. Cohort 1 was designed to assess safety and drug pharmacology, specifically the drug strain engraftment in the gastrointestinal tract. Cohort 1 included 13 subjects who received any dosing of the SER-155 regimen, with 11 subjects subsequently receiving an allo-HCT. Results from this cohort, announced in May 2023, showed SER-155 was generally well tolerated and resulted in successful drug strain engraftment and a reduction in pathogen domination in the GI microbiome relative to a historical control cohort.

Previous wording

Study Cohort 2 utilized a randomized, double-blinded 1:1 placebo-controlled design to further evaluate safety and drug strain engraftment, as well as key secondary and exploratory endpoints such as the incidence of bacterial bloodstream infections and related medical consequences such as febrile neutropenia and antibiotic use. Cohort 2 included 45 patients in the intention-to-treat (ITT) population. Of the ITT population, 20 received SER-155 and 14 received placebo, each of whom subsequently received an allo-HSCT, with data available for clinical evaluation through day 100, the study’s prespecified primary observation point. Exploratory hypothesis testing was conducted at the two-sided α=0.05 level. Ninety-five percent (95%) 2-sided confidence intervals (CIs) were determined, where specified. No adjustment for multiplicity was done. A subset of patient samples was available for drug pharmacology analysis.

Current wording

Study Cohort 2 utilized a randomized, double-blinded 1:1 placebo-controlled design to further evaluate safety and drug strain engraftment, as well as key secondary and exploratory endpoints such as the incidence of bacterial bloodstream infections and related medical consequences such as febrile neutropenia and antibiotic use. Cohort 2 included 45 patients in the intention-to-treat (ITT) population. Of the ITT population, 20 received SER-155 and 14 received placebo, each of whom subsequently received an allo-HCT, with data available for clinical evaluation through day 100, the study’s prespecified primary observation point. Exploratory hypothesis testing was conducted at the two-sided α=0.05 level. Ninety-five percent (95%) 2-sided confidence intervals (CIs) were determined, where specified. No adjustment for multiplicity was done. A subset of patient samples was available for drug pharmacology analysis.

Previous wording

Recent changes in the allo-HSCT standard of care and the increasing use of post-transplant cyclophosphamide as part of prophylactic therapy for GvHD have reduced rates of GvHD overall in this patient population. The rates of GvHD in the study were low, with two cases of grade 2 GvHD observed in each arm, and no cases of grade 3 or 4 GvHD were observed.

Current wording

Recent changes in the allo-HCT standard of care and the increasing use of post-transplant cyclophosphamide as part of prophylactic therapy for GvHD have reduced rates of GvHD overall in this patient population. The rates of GvHD in the study were low, with two cases of grade 2 GvHD observed in each arm, and no cases of grade 3 or 4 GvHD were observed.

Previous wording

In Cohort 2, the ability to detect pathogen domination (i.e., relative abundance in the GI ≥30%) in the placebo arm, and differences between the study arms, was constrained due to the limited number of placebo stool samples (placebo patients submitted fewer stool samples) and an imbalance in the number of available stool samples between the arms. Observed pathogen domination events were low in the placebo and SER-155 arms with no significant differences identified. In a comparison of the prevalence of pathogen domination versus a larger allo-HSCT historical control cohort, pathogen domination in SER-155 subjects was substantially lower, providing further evidence of SER-155 activity.

Current wording

In Cohort 2, the ability to detect pathogen domination (i.e., relative abundance in the GI ≥30%) in the placebo arm, and differences between the study arms, was constrained due to the limited number of placebo stool samples (placebo patients submitted fewer stool samples) and an imbalance in the number of available stool samples between the arms. Observed pathogen domination events were low in the placebo and SER-155 arms with no significant differences identified. In a comparison of the prevalence of pathogen domination versus a larger allo-HCT historical control cohort, pathogen domination in SER-155 subjects was substantially lower, providing further evidence of SER-155 activity.

Previous wording

We believe the available study data from Cohort 1 suggest that SER-155 administration results in significantly lower incidence rates of gastrointestinal dominations with pathogens of clinical concern, such as Enterococcaceae, Enterobacteriaceae, Streptococcaceae, and Staphylococcaceae. We further believe the resulting Cohort 2 data, together with the Cohort 1 SER-155 Phase 1b study results provide encouraging evidence to support further development of SER-155 to potentially reduce GI associated bloodstream and AMR infections as well as increase immune tolerance in individuals undergoing allo-HSCT for cancers and other serious conditions.

Current wording

We believe the available study data from Cohort 1 suggest that SER-155 administration results in significantly lower incidence rates of gastrointestinal dominations with pathogens of clinical concern, such as Enterococcaceae, Enterobacteriaceae, Streptococcaceae, and Staphylococcaceae. We further believe the resulting Cohort 2 data, together with the Cohort 1 SER-155 Phase 1b study results provide encouraging evidence to support further development of SER-155 to potentially reduce GI associated bloodstream and AMR infections as well as increase immune tolerance in individuals undergoing allo-HCT for cancers and other serious conditions.

Previous wording

In October 2025, we presented new post hoc data from our SER-155 Phase 1b trial in an oral presentation at IDWeek in Atlanta, Georgia. The presentation included new post-hoc analysis from the completed SER-155 Phase 1b study describing differences between the SER-155 and placebo groups, including the bacterial and fungal organisms causing BSIs, BSI event clinical outcomes, antibacterial prophylaxis use, and patterns of AMR among the bacterial BSI organisms. These new data illustrated that BSIs occurred despite antibacterial prophylaxis, and that BSI bacteria exhibited AMR. Resistance to multiple antibacterial agent classes was observed only in the BSI bacteria from placebo-treated participants, two of whom had fatal outcomes related to their BSIs. These new data further support the potential of SER-155 as an innovative alternative approach to the significant unmet medical need for prevention of BSIs in HSCT patients, especially those BSIs associated with AMR that increases the risk of morbidity and mortality.

Current wording

In October 2025, we presented new post hoc data from our SER-155 Phase 1b trial in an oral presentation at IDWeek in Atlanta, Georgia. The presentation included new post-hoc analysis from the completed SER-155 Phase 1b study describing differences between the SER-155 and placebo groups, including the bacterial and fungal organisms causing BSIs, BSI event clinical outcomes, antibacterial prophylaxis use, and patterns of AMR among the bacterial BSI organisms. These new data illustrated that BSIs occurred despite antibacterial prophylaxis, and that BSI bacteria exhibited AMR. Resistance to multiple antibacterial agent classes was observed only in the BSI bacteria from placebo-treated participants, two of whom had fatal outcomes related to their BSIs. These new data further support the potential of SER-155 as an innovative alternative approach to the significant unmet medical need for prevention of BSIs in HCT patients, especially those BSIs associated with AMR that increases the risk of morbidity and mortality.

Previous wording

In January 2025, we reported exploratory translational biomarker data from the SER-155 Phase 1b study which provided evidence supporting the intended therapeutic mechanisms, including promotion of intestinal epithelial barrier integrity to reduce the potential of bacterial translocation into the bloodstream, and reduction of systemic inflammatory responses. Results from this exploratory biomarker analysis showed that SER-155 was associated with lower levels of fecal albumin and lower concentrations of various plasma biomarkers associated with systemic inflammation (i.e., IFN-y, TNF-α, IL-17, and IL-8) in the HSCT peri-transplant period, the period from the end of the first SER-155 treatment course through to neutrophil engraftment. The results support SER-155’s intended mechanisms of action and reinforce the previously reported promising clinical study efficacy and safety data. These systemic inflammatory response observations further support the potential to develop our live biotherapeutics to address inflammatory and immune diseases, including ulcerative colitis and Crohn’s disease.

Current wording

In January 2025, we reported exploratory translational biomarker data from the SER-155 Phase 1b study which provided evidence supporting the intended therapeutic mechanisms, including promotion of intestinal epithelial barrier integrity to reduce the potential of bacterial translocation into the bloodstream, and reduction of systemic inflammatory responses. Results from this exploratory biomarker analysis showed that SER-155 was associated with lower levels of fecal albumin and lower concentrations of various plasma biomarkers associated with systemic inflammation (i.e., IFN-y, TNF-α, IL-17, and IL-8) in the HCT peri-transplant period, the period from the end of the first SER-155 treatment course through to neutrophil engraftment. The results support SER-155’s intended mechanisms of action and reinforce the previously reported promising clinical study efficacy and safety data. These systemic inflammatory response observations further support the potential to develop our live biotherapeutics to address inflammatory and immune diseases, including ulcerative colitis and Crohn’s disease.

Previous wording

Following advancement of key startup activities for the SER-155 Phase 2 study in allo-HSCT, including the submission of a final protocol to the FDA in January 2026, study site evaluation and qualification with our CRO, and manufacturing of drug substance, we have paused additional investment in that program while continuing to seek funding for the Phase 2 study.

Current wording

Following advancement of key startup activities for the SER-155 Phase 2 study in allo-HCT, including the submission of a final protocol to the FDA in January 2026, study site evaluation and qualification with our CRO, and manufacturing of drug substance, we have paused additional investment in that program while continuing to seek funding for the Phase 2 study.

Previous wording

We have an extensive patent portfolio directed to rationally designed ecologies of spores and microbes. The portfolio includes both company-owned patents and applications, and those that we have rights to as licensee. The patents and applications included in our portfolio cover both composition of matter and methods (e.g., method of treating). Our intellectual property rights related to SER-155, SER-147 and/or SER-603 extend through at least part of 2046 (not including any potential term extension). We plan on continuing to broaden our patent portfolio. Currently, we have 21 active patent families, which includes 18 nationalized applications and two at the provisional stage. To date, we have obtained issuance of 33 U.S. patents (which includes three as licensee). Of the issued U.S. patents, 13 U.S. patents (including one as licensee) have been assigned to Nestlé Health Science as part of its purchase of VOWST.

Current wording

We have an extensive patent portfolio directed to rationally designed ecologies of spores and microbes. The portfolio includes both company-owned patents and applications, and those that we have rights to as licensee. The patents and applications included in our portfolio cover both composition of matter and methods (e.g., method of treating). Our intellectual property rights related to SER-155, SER-147 and/or SER-603 extend through at least part of 2046 (not including any potential term extension). We plan on continuing to broaden our patent portfolio. Currently, we have 20 active patent families, which includes 16 nationalized applications, three at the PCT stage, and one at the provisional stage. To date, we have obtained issuance of 33 U.S. patents (which includes three as licensee). Of the issued U.S. patents, 13 U.S. patents (including one as licensee) have been assigned to Nestlé Health Science as part of its purchase of VOWST.

Previous wording

Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We anticipate an overall decrease in research and development expenses in 2026 as compared to 2025, following the conclusion of the TSA, completion of the Phase 1b study of SER-155 in allo-HSCT, and the cost reduction actions that were implemented in September 2025 and February 2026, including pausing investment in the SER-155 Phase 2 study and headcount reductions. Research and development expenses may increase in the future if and as we resume development of any clinical or preclinical programs. In 2025, research and development expenses included labor and passthrough costs, reimbursable by Nestlé, incurred in performing obligations under the TSA. Given the conclusion of the TSA as of December 31, 2025, these costs and related reimbursements are not expected to reoccur in 2026.

Current wording

Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We anticipate an overall decrease in research and development expenses in 2026 as compared to 2025, following the conclusion of the TSA, completion of the Phase 1b study of SER-155 in allo-HCT, and the cost reduction actions that were implemented in September 2025 and February 2026, including pausing investment in the SER-155 Phase 2 study and headcount reductions. Research and development expenses may increase in the future if and as we resume development of any clinical or preclinical programs. In 2025, research and development expenses included labor and passthrough costs, reimbursable by Nestlé, incurred in performing obligations under the TSA. Given the conclusion of the TSA as of December 31, 2025, these costs and related reimbursements are not expected to reoccur in 2026.

Previous wording

Since our inception in 2010, we have not recorded any U.S. federal or state income tax benefits for the net losses we have incurred in each year or our earned research and development tax credits, due to our uncertainty of realizing a benefit from those items. We did not provide for any income taxes in the three months ended March 31, 2026 or 2025.

Current wording

Since our inception in 2010, we have not recorded any U.S. federal or state income tax benefits for the net losses we have incurred in each year or our earned research and development tax credits, due to our uncertainty of realizing a benefit from those items. We did not provide for any income taxes in the three and six months ended June 30, 2026 or 2025.

Previous wording

Our condensed consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States. The preparation of these condensed consolidated financial statements requires the application of appropriate technical accounting rules and guidance, as well as the use of estimates. The application of these policies necessarily involves judgments regarding future events. These estimates and judgments, in and of themselves, could materially impact the condensed consolidated financial statements and disclosures based on varying assumptions. The accounting policies discussed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on March 12, 2026, or the Annual Report, are considered by management to be the most important to an understanding of the consolidated financial statements because of their significance to the portrayal of our financial condition and results of operations. There have been no material changes to that information disclosed in our Annual Report during the three months ended March 31, 2026.

Current wording

Our condensed consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States. The preparation of these condensed consolidated financial statements requires the application of appropriate technical accounting rules and guidance, as well as the use of estimates. The application of these policies necessarily involves judgments regarding future events. These estimates and judgments, in and of themselves, could materially impact the condensed consolidated financial statements and disclosures based on varying assumptions. The accounting policies discussed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on March 12, 2026, or the Annual Report, are considered by management to be the most important to an understanding of the consolidated financial statements because of their significance to the portrayal of our financial condition and results of operations. There have been no material changes to that information disclosed in our Annual Report during the three and six months ended June 30, 2026.

Previous wording

Total revenue was $0.4 million for the three months ended March 31, 2026 consisting of costs reimbursable under the CARB-X grant that we were awarded in the third quarter of 2025.

Current wording

Total revenue was $0.7 million for the three months ended June 30, 2026 consisting of costs reimbursable under the CARB-X grant that we were awarded in the third quarter of 2025.

Previous wording

a decrease in personnel-related costs of $0.2 million primarily due to a decrease in salaries, bonuses, employee benefits expenses, and stock-based compensation expense of $1.5 million due to lower headcount, partially offset by an increase of $0.6 million of severance expense related to the cost reduction actions announced in February 2026 and an increase of

Current wording

a decrease in personnel-related costs of $2.4 million primarily due to a decrease in salaries, bonuses, employee benefits expenses, and stock-based compensation expense due to lower headcount;

Previous wording

an increase of $0.1 million in expenses related to our early stage programs primarily related to activities associated with the development of SER-428, for which the related reimbursements received from CARB-X are included within grant revenue, partially offset by

Current wording

an increase of $0.5 million in expenses related to our early stage programs primarily related to activities associated with the development of SER-428, for which the related reimbursements received from CARB-X are included within grant revenue.

Previous wording

General and administrative expenses were $8.1 million for the three months ended March 31, 2026 compared to $11.9 million for the three months ended March 31, 2025. The decrease of $3.8 million was primarily due to the following:

Current wording

General and administrative expenses were $7.1 million for the three months ended June 30, 2026 compared to $10.3 million for the three months ended June 30, 2025. The decrease of $3.2 million was primarily due to the following:

Previous wording

a decrease in personnel-related costs of $0.9 million primarily due to a decrease in salaries, bonuses, employee benefits expenses, and stock-based compensation expenses due to lower headcount;

Current wording

a decrease in personnel-related costs of $1.1 million primarily due to a decrease in salaries, bonuses, employee benefits expenses, and stock-based compensation expenses due to lower headcount;

Previous wording

a decrease in professional fees of $1.4 million due to lower legal and consulting fees, and

Current wording

a decrease in professional fees of $0.7 million due to lower legal and consulting fees, and

Previous wording

Manufacturing services costs were incurred between the fourth quarter of 2024 and the end of 2025 as we performed PRMS manufacturing on behalf of Nestlé in accordance with the TSA. The expenses associated with manufacturing services included labor, materials, allocated facility-related, lab supplies and other manufacturing costs that would have been capitalized into inventory prior to the sale of VOWST Business. Following the conclusion of the TSA on December 31, 2025, no manufacturing services costs were incurred during the three months ended March 31, 2026 and none are expected moving forward.

Current wording

Manufacturing services costs were incurred between the fourth quarter of 2024 and the end of 2025 as we performed PRMS manufacturing on behalf of Nestlé in accordance with the TSA. The expenses associated with manufacturing services included labor, materials, allocated facility-related, lab supplies and other manufacturing costs that would have been capitalized into inventory prior to the sale of VOWST Business. Following the conclusion of the TSA on December 31, 2025, no further manufacturing services costs were incurred and none are expected moving forward.

Previous wording

Other income (expense), net was $1.0 million of income and $59.9 million of income for the three months ended March 31, 2026 and 2025, respectively. The decrease of $58.9 million in other income, net was due to the $52.2 million gain on sale of the VOWST business recognized in the three months ended March 31, 2025, primarily due to the installment payment received from Nestlé in January 2025 that was conditioned on our material compliance with obligations under the TSA, as well as $6.3 million of reimbursement income associated with the performance of TSA services in the first quarter of 2025 that did not reoccur due to the conclusion of the TSA at the end of 2025, and a decrease in interest income of $0.3 million due to our lower cash balance.

Current wording

Other income (expense), net was $25.9 million of income and $5.0 million of income for the three months ended June 30, 2026 and 2025, respectively. The increase of $20.8 million in other income, net was primarily due to the $25.0 million Gain on sale of VOWST business related to the Milestone Termination Payment expected to be received from SPN in July and October 2026, partially offset by $3.5 million of reimbursement income associated with the performance of TSA services in the second quarter of 2025 that did not reoccur due to the conclusion of the TSA at the end of 2025, and a decrease in interest income of $0.3 million due to our lower cash balance.

Previous wording

an increase of $1.4 million in expenses related to our live biotherapeutics platform and research and development operations primarily due to the conclusion of the TSA with Nestlé as of December 31, 2025, under which a portion of our facility costs and other operational costs were included within manufacturing services expenses and were reimbursed by Nestlé in 2025, and

Current wording

an increase of $0.5 million in expenses related to our live biotherapeutics platform and research and development operations primarily due to the conclusion of the TSA with Nestlé as of December 31, 2025, under which a portion of our facility costs and other operational costs were included within manufacturing services expenses and were reimbursed by Nestlé in 2025, partially offset by a reduction in facilities costs related to the Lease Amendment that was effective during the second quarter of 2026; and

Previous wording

a decrease in facility-related and other costs of $1.5 million primarily related to information technology costs that were incurred as part of the TSA and reimbursed by Nestlé that did not reoccur in 2026.

Current wording

a decrease in facility-related and other costs of $2.9 million primarily related to information technology costs that were incurred as part of the TSA and reimbursed by Nestlé that did not reoccur in 2026.

Previous wording

In May 2021, we entered into a Sales Agreement, or the Sales Agreement, with Cowen and Company, LLC, or Cowen, to sell shares of our common stock, with aggregate gross sales proceeds of up to $150.0 million, from time to time, through an “at the market” equity offering program under which Cowen acts as sales agent. During the three months ended March 31, 2026, we sold 25,796 shares of common stock under the Sales Agreement, at an average price of approximately $15.90 per share, raising aggregate net proceeds of approximately $0.4 million after deducting an aggregate commission of approximately 3%. During the three months ended March 31, 2025, we sold 54,806 of common stock under the Sales Agreement, at an average price of approximately $18.60 per share, raising aggregate net proceeds of approximately $1.0 million after deducting an aggregate commission of approximately 3% and other issuance costs. As of March 31, 2026, we have sold 2,214,491 shares of common stock under the Sales Agreement, at an average price of approximately $28.07 per share, raising aggregate net proceeds of approximately $59.7 million after deducting an aggregate commission of approximately 3% and other issuance costs.

Current wording

In May 2021, we entered into a Sales Agreement, or the Sales Agreement, with Cowen and Company, LLC, or Cowen, to sell shares of our common stock, with aggregate gross sales proceeds of up to $150.0 million, from time to time, through an “at the market” equity offering program under which Cowen acts as sales agent. During the three and six months ended June 30, 2026, we sold 232,286 and 258,082 shares of common stock under the Sales Agreement, at an average price of approximately $7.99 and $8.78 per share, raising aggregate net proceeds of approximately $1.7 million and $2.1 million after deducting an aggregate commission of approximately 3%. During the six months ended June 30, 2025, we sold 54,806 of common stock under the Sales Agreement, at an average price of approximately $18.60 per share, raising aggregate net proceeds of approximately $1.0 million after deducting an aggregate commission of approximately 3% and other issuance costs. As of June 30, 2026, we have sold 2,446,777 shares of common stock under the Sales Agreement, at an average price of approximately $26.16 per share, raising aggregate net proceeds of approximately $61.4 million after deducting an aggregate commission of approximately 3% and other issuance costs.

Previous wording

As of March 31, 2026, we had cash and cash equivalents totaling $29.8 million and an accumulated deficit of $992.3 million. For the three months ended March 31, 2026, we incurred a net loss of $19.9 million. We expect that our operating losses and negative cash flows will continue for the foreseeable future.

Current wording

As of June 30, 2026, we had cash and cash equivalents totaling $15.6 million and an accumulated deficit of $987.7 million. For the six months ended June 30, 2026, we incurred a loss from operations of $42.2 million. We expect that our operating losses and negative cash flows will continue for the foreseeable future.

Previous wording

Under applicable accounting standards, we have the responsibility to evaluate whether conditions or events raise substantial doubt about our ability to meet our future financial obligations as they become due within 12 months after the date the consolidated financial statements are issued. The ability to obtain sufficient proceeds from additional equity offerings, collaborations or other financing with terms favorable or acceptable to us cannot be considered probable, as these events are outside of our control. Based on our currently available cash resources, and considering our future operating plans, we anticipate that we will require additional funding following the third quarter of 2026. Accordingly, management has concluded that these circumstances raise substantial doubt about our ability to continue as a going concern. Substantial doubt about our ability to continue as a going concern may materially and adversely affect the price per share of our common stock, and it may be more difficult for us to obtain financing. If potential collaborators decline to do business with us or potential investors decline to participate in any future financings due to such concerns, our ability to increase our cash position may be limited. We will need to generate significant revenues to achieve profitability, and we may never do so. Because of the numerous risks and uncertainties associated with the development of our current and any future product candidates, the development of our platform and technology and because the extent to which we may enter into collaborations with third parties for development of any of our product candidates is unknown, we are unable to estimate the amounts of increased capital outlays and operating expenses required for completing the research and development of our product candidates.

Current wording

Under applicable accounting standards, we have the responsibility to evaluate whether conditions or events raise substantial doubt about our ability to meet our future financial obligations as they become due within 12 months after the date the consolidated financial statements are issued. The ability to obtain sufficient proceeds from additional equity offerings, collaborations or other financing with terms favorable or acceptable to us cannot be considered probable, as these events are outside of our control. Based on our currently available cash resources, the $12.5 million Milestone Termination Payment received from SPN in July 2026, and the expected receipt of the additional $12.5 million Milestone Termination Payment due from SPN in October 2026, and considering our future operating plans, we anticipate that we will require additional funding following the first quarter of 2027. Accordingly, management has concluded that these circumstances raise substantial doubt about our ability to continue as a going concern. Substantial doubt about our ability to continue as a going concern may materially and adversely affect the price per share of our common stock, and it may be more difficult for us to obtain financing. If potential collaborators decline to do business with us or potential investors decline to participate in any future financings due to such concerns, our ability to increase our cash position may be limited. We will need to generate significant revenues to achieve profitability, and we may never do so. Because of the numerous risks and uncertainties associated with the development of our current and any future product candidates, the development of our platform and technology and because the extent to which we may enter into collaborations with third parties for development of any of our product candidates is unknown, we are unable to estimate the amounts of increased capital outlays and operating expenses required for completing the research and development of our product candidates.