WALTHAM, Mass., Nov. 25, 2025 (GLOBE NEWSWIRE) -- Upstream Bio, Inc. (Nasdaq: UPB), a clinical-stage company developing treatments for inflammatory diseases, with an initial focus on severe respiratory disorders, today announced that Rand Sutherland, MD, Chief Executive Officer of Upstream Bio, will be participating in the following upcoming investor conferences in December: Piper Sandler 37th Annual Healthcare Conference, New York, NYTuesday, December 2, 2025, Fireside Chat – 4:30 p.m. ET8th Annual Evercor ...

Upstream Bio Conference Call Summary Company Overview - **Company**: Upstream Bio (NasdaqGS:UPB) - **Event**: First annual I&I Summit - **Date**: November 12, 2025 Key Industry Insights Drug Development and Efficacy - Upstream Bio presented positive Phase 2 data for **verekitug**, an antibody targeting the **TSLP receptor**, showing long pharmacodynamic activity with a dosing schedule of Q12 weeks [3][5][6] - The drug demonstrated a **76% reduction** in systemic corticosteroid use and surgery needs in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) [9][10] - The data indicated that there was no plateau in efficacy at 24 weeks, suggesting potential for continued improvement in longer studies [4][8] Clinical Trial Progression - Upstream Bio is advancing towards Phase 3 trials for both CRSwNP and severe asthma, with plans to analyze data from both indications contemporaneously to inform dose selection [11][12] - The company aims to initiate Phase 3 programs as quickly as possible, contingent on data analysis and regulatory feedback [31] Competitive Landscape - Upstream Bio differentiates itself from competitors by targeting the **TSLP receptor** rather than the ligand, which is the approach taken by other companies [34][35] - The competitive landscape includes drugs from GSK and ILOS, which are reportedly behind Upstream Bio in development timelines [32][34] Additional Important Points Pharmacodynamics and Dosing - The pharmacodynamic profile of verekitug suggests that it maintains receptor occupancy for up to **24 weeks** after the last dose, which is critical for sustained efficacy [24][22] - The company is exploring the potential for extended dosing intervals (Q24 weeks) while ensuring that efficacy is not compromised [17][22] Regulatory Considerations - Upstream Bio is focused on obtaining robust data to support regulatory negotiations, with a primary endpoint of asthma exacerbation reduction set at **50% or greater** [26][28] - The company is preparing for potential discussions with regulators regarding the design of future trials, including considerations for secondary endpoints like lung function improvement [30][31] Future Data Releases - Upcoming data from the Phase 2 trials is expected in Q1, with plans to present findings at major medical meetings such as QuadAI and ATS in the first half of the following year [38] This summary encapsulates the critical insights and developments discussed during the Upstream Bio conference call, highlighting the company's strategic direction and competitive positioning within the biotech industry.

Core Insights - Upstream Bio, Inc. reported positive top-line results from the VIBRANT Phase 2 trial of verekitug in chronic rhinosinusitis with nasal polyps (CRSwNP), demonstrating significant efficacy and a favorable safety profile [1][5] - The company is on track to report results from the VALIANT Phase 2 trial in severe asthma in the first quarter of 2026, with ongoing enrollment in the VENTURE Phase 2 trial for chronic obstructive pulmonary disease (COPD) [1][4][12] - Financial results for Q3 2025 show a net loss of $33.7 million, with increased research and development expenses primarily related to verekitug programs [8][10][19] Recent Business Highlights - The VIBRANT Phase 2 trial met its primary endpoint with a statistically significant reduction in placebo-adjusted endoscopic nasal polyp score of -1.8 (p<0.0001) [5] - Key secondary endpoints showed a reduction in nasal congestion score of -0.8 (p=0.0003) and a 76% (p=0.03) reduction in the need for surgery or systemic corticosteroids [5] - Structural and mechanistic data presented at the European Respiratory Society Congress highlighted verekitug's unique mechanism of action in disrupting TSLP signaling [2][12] Upcoming Milestones - Top-line data from the VALIANT Phase 2 trial in severe asthma is expected in Q1 2026, with the trial designed to assess efficacy and safety in extended dosing intervals of 12 and 24 weeks [4] - Enrollment is ongoing in the VENTURE Phase 2 trial for COPD, with the first patient dosed in July 2025 [1][12] Financial Overview - As of September 30, 2025, Upstream Bio had cash, cash equivalents, and short-term investments totaling $372.4 million, expected to fund operations through 2027 [8] - Research and development expenses for Q3 2025 were $33.0 million, up from $15.4 million in the same period in 2024, reflecting increased clinical and manufacturing costs [8][10] - General and administrative expenses rose to $5.5 million in Q3 2025, compared to $4.1 million in Q3 2024, driven by personnel-related costs [9]

Core Insights - Upstream Bio, Inc. is a clinical-stage biotechnology company focused on developing treatments for inflammatory diseases, particularly severe respiratory disorders [2] - The company is advancing its lead candidate, verekitug, which targets the receptor for thymic stromal lymphopoietin (TSLP), into Phase 2 trials for chronic rhinosinusitis with nasal polyps, severe asthma, and chronic obstructive pulmonary disease [2] Upcoming Events - Rand Sutherland, CEO of Upstream Bio, will participate in several investor conferences in November 2025, including the Truist Securities BioPharma Symposium on November 6, Stifel 2025 Healthcare Conference on November 11, and TD Cowen Immunology and Inflammation Summit on November 12 [1][3] - Live webcasts of the presentations will be available on Upstream Bio's website, with replays posted afterward [1]

Core Insights - Upstream Bio, Inc. is advancing its clinical-stage monoclonal antibody, verekitug, which targets the TSLP receptor, showing potential for treating severe respiratory diseases [1][10] - Recent data presented at the European Respiratory Society Congress indicate verekitug's unique mechanism of action may lead to differentiated therapeutic effects across various TSLP-driven inflammatory diseases [1][2] Mechanism of Action - Verekitug prevents TSLP from binding to its receptor by occupying ligand binding sites and outcompetes TSLP even in the presence of preformed receptor complexes [1][6] - The high affinity of verekitug (KD < 1 pM) allows it to inhibit proinflammatory signaling initiated by TSLP effectively [6][8] Clinical Development - Verekitug has shown rapid and sustained TSLP receptor inhibition for up to 24 weeks post-administration, indicating a potential for less frequent dosing compared to existing biologic therapies [2][9] - The recently completed VIBRANT trial demonstrated that a single dose of 100 mg verekitug every 12 weeks met both primary and secondary endpoints in patients with chronic rhinosinusitis with nasal polyps [7][10] - Ongoing trials include the VALIANT trial for severe asthma and the VENTURE trial for moderate-to-severe chronic obstructive pulmonary disease (COPD) [7][10] Preclinical and Clinical Data - Preclinical studies have shown verekitug's high occupancy of the TSLP receptor and its ability to inhibit cytokine production from CD4+ T cells and ILC2 cells [8] - In Phase 1 trials, verekitug was well tolerated and demonstrated significant reductions in fractional exhaled nitric oxide (FeNO) and blood eosinophils in asthma patients [9] Company Overview - Upstream Bio is focused on developing treatments for inflammatory diseases, particularly severe respiratory disorders, with verekitug being the only known antagonist targeting the TSLP receptor currently in clinical development [10]

VIBRANT Phase 2 Study Results - The Phase 2 VIBRANT study of verekitug in CRSwNP met the primary endpoint, demonstrating a statistically significant reduction in Nasal Polyp Score (NPS) of -1.8 (p<0.0001) [11, 71, 85] - Key secondary endpoints were also met, including a Nasal Congestion Score (NCS) reduction of -0.8 (p=0.0003) [11, 71, 85] and a 76% reduction in the need for surgery or systemic steroids (p=0.03) [11, 71, 85] - Verekitug, dosed every 12 weeks, showed clinical activity at week 24 similar to tezepelumab dosed every 4 weeks [14, 65] - In the VIBRANT trial, 93% of subjects completed the study [38] Safety and Tolerability - Verekitug was generally well tolerated, with no serious adverse events (SAEs) observed [11, 71, 85] - The incidence of adverse events (AEs) was similar across treatment groups, with treatment-emergent adverse events (TEAEs) related to study treatment occurring more frequently in the placebo group [48] Verekitug's Potential - Upstream Bio is developing verekitug as an antagonist of the TSLP receptor, with the goal of achieving rapid, complete, and sustained receptor occupancy for up to 24 weeks after the last dose [21] - Current biologics sales in CRSwNP alone are estimated to exceed $1 billion globally [29] - Upstream Bio is studying verekitug across multiple indications with high unmet need, including severe asthma (VALIANT trial, topline data expected in Q1 2026) and COPD (VENTURE trial, currently enrolling) [22, 23]

Group 1 - Upstream Bio, Inc. is a clinical-stage biotechnology company focused on developing treatments for inflammatory diseases, particularly severe respiratory disorders [4] - The company is advancing verekitug, a monoclonal antibody targeting the receptor for thymic stromal lymphopoietin (TSLP), which is involved in inflammatory responses [4] - The Phase 2 VIBRANT trial is designed to evaluate the efficacy and safety of verekitug in adults with chronic rhinosinusitis with nasal polyps (CRSwNP) [2] Group 2 - The VIBRANT trial is a global, randomized, placebo-controlled study where participants receive either 100 mg of verekitug or a placebo every 12 weeks for 24 weeks [2] - The primary endpoint of the trial is the change in endoscopic nasal polyp score (NPS) at Week 24 [2] - Top-line data from the VIBRANT trial will be reported on September 2, 2025, during a conference call and webcast [1][3]

Core Insights - Upstream Bio reported significant clinical advancements and financial results for Q2 2025, with a focus on its lead drug candidate, verekitug, aimed at treating respiratory diseases [1][5][12] Financial Performance - Revenue for Q2 2025 was $0.9 million, exceeding the estimate of $0.69 million and showing an 80% increase from $0.5 million in Q2 2024 [2][8] - Research and development expenses surged to $37.9 million, up 168.8% from $14.1 million in Q2 2024, primarily due to increased clinical and manufacturing costs related to verekitug [2][7] - General and administrative expenses rose to $7.4 million, an 85% increase from $4.0 million in Q2 2024 [2][7] - The net loss widened to $40.0 million compared to $14.7 million in Q2 2024, reflecting the transition to more expensive Phase 2 trials [2][8] - Cash reserves stood at $393.6 million as of June 30, 2025, expected to sustain operations through 2027 [8][12] Clinical Development - Upstream Bio is advancing verekitug through multiple Phase 2 clinical trials, with significant milestones achieved in severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) [1][4] - Patient enrollment for the VALIANT Phase 2 trial for severe asthma was completed in June 2025, with top-line results anticipated in early 2026 [5][12] - The VIBRANT Phase 2 trial for CRSwNP completed patient enrollment by January 2025, with efficacy data expected in Q3 2025 [5][12] - The company initiated dosing in the VENTURE Phase 2 trial for chronic obstructive pulmonary disease (COPD) in July 2025 [6][12] Product Pipeline and Competitive Position - Verekitug is the only monoclonal antibody in human trials targeting the TSLP receptor, which may offer longer intervals between doses compared to existing biologics [10][11] - The competitive landscape remains uncertain as there are no approved products or recent head-to-head data against other biologics [11] - The regulatory strategy focuses on trial endpoints that could support future marketing applications if successful [11] Future Outlook - Management highlighted two key upcoming catalysts: top-line data from the VIBRANT CRSwNP Phase 2 trial in Q3 2025 and the VALIANT severe asthma Phase 2 readout in Q1 2026 [12][13] - Investors are expected to closely monitor the outcomes of these trials, as positive results could lead to regulatory submissions and potential partnerships [13]

Core Insights - Upstream Bio, Inc. is advancing its clinical development programs for verekitug, a monoclonal antibody targeting the TSLP receptor, focusing on severe respiratory diseases such as chronic rhinosinusitis with nasal polyps (CRSwNP), severe asthma, and chronic obstructive pulmonary disease (COPD) [1][2] Clinical Development Progress - The company is on track to report top-line data from the Phase 2 trial in CRSwNP in the third quarter of 2025 [1][5] - Enrollment in the Phase 2 trial for severe asthma was completed in June 2025, with top-line data expected in the first quarter of 2026 [1][5] - The first patient was dosed in the Phase 2 trial for COPD in July 2025, marking the entry into a third major respiratory indication [1][5] Financial Performance - As of June 30, 2025, Upstream Bio had cash, cash equivalents, and short-term investments totaling $393.6 million, which is projected to fund operations through 2027 [6] - Research and development expenses for the second quarter of 2025 were $37.9 million, a significant increase from $14.1 million in the same period of 2024, primarily due to clinical and manufacturing costs related to verekitug [6] - General and administrative expenses rose to $7.4 million for the quarter ended June 30, 2025, compared to $4.0 million for the same period in 2024, driven by personnel-related expenses and professional service fees [7] Net Loss - The net loss for the quarter ended June 30, 2025, was $40.0 million, compared to a net loss of $14.7 million for the same period in 2024, largely due to increased operating expenses [8][16]

Core Insights - Upstream Bio has initiated a Phase 2 clinical trial, VENTURE, to evaluate the efficacy and safety of verekitug in patients with moderate-to-severe COPD, marking the expansion of its global development program into a third indication [1][3] - Verekitug is a novel antibody antagonist targeting the TSLP receptor, which plays a significant role in the inflammatory response associated with allergic and inflammatory diseases [2][6] - The trial aims to assess the annualized rate of moderate or severe COPD exacerbations as the primary endpoint, with secondary endpoints including changes in symptoms and lung function [4] Company Overview - Upstream Bio is a clinical-stage biotechnology company focused on developing treatments for inflammatory diseases, particularly severe respiratory disorders [17] - The company is advancing verekitug, the only known monoclonal antibody in clinical development targeting the TSLP receptor, through multiple Phase 2 trials for CRSwNP, severe asthma, and COPD [9][17] - The company aims to address unmet needs in patient populations underserved by current standard treatments [18] Clinical Trial Details - The VENTURE trial is a randomized, double-blind, placebo-controlled study involving approximately 670 adults with moderate-to-severe COPD, with treatment periods ranging from 60 to 108 weeks [3][4] - Participants will receive either verekitug at doses of 100 mg every 12 weeks, 400 mg every 24 weeks, or a placebo [3] - The trial is designed to potentially support regulatory submissions based on the data collected [4] Current Research and Development - Upstream Bio has completed enrollment in separate Phase 2 trials for CRSwNP and severe asthma, with top-line data expected in the third quarter of 2025 and the first quarter of 2026, respectively [5] - Preclinical studies have shown that verekitug effectively inhibits TSLP signaling and demonstrates potential efficacy against various types of inflammation [10][11] Disease Context - COPD is a chronic inflammatory disease that significantly impacts airflow and is associated with high morbidity and mortality, being the fourth leading cause of death globally [12][14] - The prevalence of COPD is projected to increase due to ongoing exposure to risk factors and an aging population [14] - Current treatments for COPD include inhaled steroids and bronchodilators, with biologics emerging as new treatment options [16]