WALTHAM, Mass., Sept. 09, 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 participate in a fireside chat at the Stifel 2025 Virtual Immunology and Inflammation Forum on September 15, 2025 at 10:30 a.m. ET. A live webcast of the fireside chat will be available under the Events tab on ...

Core Points - Upstream Bio is hosting a conference call to discuss the Phase II VIBRANT top-line results of their lead asset, Verekitug [1][4] - The call includes forward-looking statements regarding the company's expectations and beliefs about future events [2] - Comparisons of Verekitug against existing treatments are based on third-party published data, with caution advised due to differences in trial designs and patient characteristics [3] Company Overview - Upstream Bio's CEO, Dr. Rand Sutherland, and Chief Medical Officer, Dr. Aaron Deykin, are present to discuss the results and future plans for Verekitug [4] - The agenda includes an overview of the results and a detailed review of the Phase II VIBRANT clinical study top-line results [4]

Summary of Upstream Bio Phase Two Vibrant Top-Line Results Conference Call Company Overview - **Company**: Upstream Bio - **Lead Asset**: Virecotag, an antagonist of the TSLP receptor - **Focus**: Severe respiratory diseases, including chronic rhinosinusitis with nasal polyps (CRS with NP), severe asthma, and COPD [7][24] Industry Context - **Market Size**: Sales of therapies for CRS with NP exceed $1 billion annually and are projected to grow due to new agents and expanded use [9] - **Current Treatments**: Comparison with existing treatments like Tezepelumab and Dupilumab, highlighting the need for more frequent dosing in other agents [6][20][21] Key Clinical Trial Results - **Trial Design**: Phase Two, randomized, double-blind, placebo-controlled trial with 81 participants [11][12] - **Primary Endpoint**: Significant reduction in endoscopic nasal polyp score (NPS) by 1.8 points and nasal congestion score (NCS) by 0.8 points at 24 weeks [16][17] - **Secondary Endpoints**: Improvements in sinus opacification, total symptom score, and a 76% reduction in the need for steroids or surgery [17][22] - **Safety Profile**: Virecotag was well tolerated with no serious adverse events reported; common treatment emergent adverse events included upper respiratory infections and sinusitis [15][16] Mechanism of Action - **Potency**: Virecotag is approximately 300-fold more potent than Tezepelumab due to its unique mechanism targeting the TSLP receptor [8] - **Dosing Interval**: Administered every 12 weeks, significantly less frequent than other biologics [6][20] Future Development Plans - **Upcoming Trials**: - Valiant trial in severe asthma expected to report top-line data in Q1 2026 [7][25] - Ongoing Venture trial in COPD [7] - **Potential Expansion**: Plans to explore Virecotag's efficacy in other therapeutic areas, including dermatology and gastrointestinal diseases [7] Market Opportunity - **Unmet Need**: High interest among allergists and ENT specialists for biologics targeting TSLP in CRS with NP [9] - **Commercial Strategy**: Focus on maximizing the value of Virecotag across multiple indications with substantial unmet needs [7][24] Additional Insights - **Subgroup Analysis**: Preliminary data suggests consistent efficacy across various patient subgroups, including those with comorbid asthma [19][40] - **Long-term Efficacy**: Anticipation of greater treatment effects with longer studies, as seen with other agents [38][46] Conclusion - **Overall Sentiment**: Positive trial results reinforce the potential of Virecotag as a differentiated treatment option for CRS with NP and other respiratory diseases, with a favorable safety profile and significant clinical benefits [22][24]

Verekitug Phase 2 CRSwNP Top-line Results September 2, 2025 © 2025 Upstream Bio, Inc. No Image Disclaimer This presentation contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "continue," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "predict ...

Core Insights - Upstream Bio, Inc. announced positive top-line results from the Phase 2 VIBRANT trial for verekitug, demonstrating significant efficacy in treating chronic rhinosinusitis with nasal polyps (CRSwNP) [1][6][12] Study Results - The VIBRANT trial met its primary endpoint with a statistically significant placebo-adjusted reduction in endoscopic nasal polyp score (NPS) of -1.8 (p<0.0001) at Week 24 [1][4] - Key secondary endpoints showed a reduction in nasal congestion score (NCS) by -0.8 (p=0.0003) and a 76% reduction (p=0.03) in the need for surgery or systemic corticosteroids [1][2][5] - The trial involved 81 adults and was designed as a global, randomized, double-blind, placebo-controlled study over 24 weeks [3][12] Safety Profile - Verekitug was generally well tolerated, with no serious adverse events (SAEs) reported, consistent with previous studies [1][5][6] Mechanism and Potential - Verekitug is a monoclonal antibody targeting the thymic stromal lymphopoietin (TSLP) receptor, which is unique in its mechanism of action compared to existing therapies [1][13][18] - The results suggest that verekitug could advance the standard of care for CRSwNP and may have potential applications in other respiratory diseases, including severe asthma [6][7][18] Future Plans - Upstream Bio plans to engage with global regulatory authorities for further development and potential product approval of verekitug [7][12] - The company will present additional details from the VIBRANT trial at an upcoming medical conference [8]

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]

Upstream Bio (UPB 8.32%), a biotechnology company developing new therapies for respiratory diseases, released its second quarter 2025 results on August 6, 2025. The main headline was rapid advancement in clinical trials for its lead drug candidate, verekitug, with major enrollment milestones hit in severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). Revenue (GAAP) was $0.9 million for Q2 2025, above the $0.69 million estimate. Year on year, the company's investment in research and developme ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________________ to _________________ Commission File Number: 001-42366 UPSTREAM BIO, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 38-41 ...

Upstream Bio Reports Second Quarter 2025 Financial Results and Highlights Continued Progress Upcoming Milestones and Recent Business Highlights • Two key upcoming top-line readouts: o Top-line data from the VIBRANT Phase 2 trial in patients with CRSwNP expected in the third quarter of 2025: VIBRANT is a Phase 2 global, randomized, double-blind, placebo-controlled, parallel group clinical trial designed to assess the efficacy and safety of verekitug in participants with CRSwNP, dosed every 12 weeks. Patient ...

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]