Upstream Bio Announces Q3 2024 Financial Results and Business Updates

Upstream Bio, Inc., a clinical-stage company focused on developing treatments for severe respiratory disorders, announced its financial results for the third quarter ending September 30, 2024. The company also shared recent business progress.

Upstream Bio is actively advancing the development of verekitug, a monoclonal antibody that targets the thymic stromal lymphopoietin (TSLP) receptor, for severe respiratory diseases. The company expects to announce top-line data from ongoing Phase 2 clinical trials for severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) in the second half of 2026 and 2025, respectively. Planning for a Phase 2 clinical trial in chronic obstructive pulmonary disease (COPD) has commenced, with the first patient dosing expected in the latter half of 2025.

The company completed an upsized initial public offering (IPO) in October, raising approximately $293 million in gross proceeds. This financial boost is anticipated to fund operations through 2027. Additionally, this quarter saw the presentation of Phase 1b trial data for verekitug in asthma patients at the European Respiratory Society (ERS) Conference. The data indicated that verekitug is highly potent, showing a 50% greater effect on fractional exhaled nitric oxide (FeNO) compared to tezepelumab.

The Phase 2 clinical trials are testing dosing intervals of 12 and 24 weeks for patients with severe asthma and 12 weeks for patients with CRSwNP. The goal is to determine if verekitug's potency translates into a differentiated clinical profile in terms of efficacy and dosing frequency. Dr. Rand Sutherland, CEO of Upstream Bio, emphasized the significant progress made towards developing verekitug and the company's strategy to leverage its unique mechanism to improve treatment options for patients with severe inflammatory diseases.

In September, at the ERS Conference, Upstream Bio presented data from the Phase 1b multiple ascending dose trial of verekitug in adults with asthma. Predictive modeling based on pharmacodynamic (PD) and pharmacokinetic (PK) parameters suggested that verekitug might exhibit higher potency in asthma patients. Verekitug showed an approximately 1.5-fold greater maximal predicted reduction of FeNO compared to tezepelumab. The trial demonstrated that verekitug maintained trough serum levels above FeNO EC90 levels for over 95% of the dosing interval. These findings supported testing the 100 mg once every 12 weeks (Q12W) and 400 mg once every 24 weeks (Q24W) dosing regimens in the ongoing Phase 2 VALIANT trial for severe asthma.

Verekitug was well tolerated at all dose levels tested in the Phase 1b trial. It showed rapid and substantial treatment effects, including 100% TSLP receptor occupancy after one dose, up to 54% reduction in FeNO, and up to 65% reduction in blood eosinophils at 12 weeks. These effects were sustained for up to 24 weeks after the last dose.

In October, Upstream Bio appointed Daniella Beckman to its Board of Directors as an independent director and chair of the Audit Committee. Beckman brings over 20 years of financial and operational leadership experience in the biotechnology industry.

Financially, as of September 30, 2024, Upstream Bio reported cash, cash equivalents, and short-term investments totaling $220.7 million, up from $109.8 million as of December 31, 2023. The net proceeds from the October IPO are expected to support planned operations through 2027. Research and development expenses for the third quarter were $15.4 million, compared to $7.8 million for the same period in 2023. This increase was mainly due to higher clinical and manufacturing expenses related to the verekitug program. General and administrative expenses rose to $4.1 million from $2.2 million in the previous year, primarily due to increased personnel expenses. The net loss for the quarter was $16.0 million, compared to $3.1 million for the same period in 2023, reflecting the higher research and development expenses and other income recorded due to changes in the value of preferred stock right tranche liabilities.

Upstream Bio plans to participate in upcoming conferences, including the Piper Sandler 36th Annual Healthcare Conference in December 2024, the 43rd Annual J.P. Morgan Healthcare Conference in January 2025, and the 45th Annual TD Cowen Healthcare Conference in March 2025.

Upstream Bio is dedicated to developing treatments for inflammatory diseases, initially focusing on severe respiratory disorders. The company is advancing verekitug, a potent monoclonal antibody targeting the TSLP receptor, into Phase 2 trials for severe asthma and CRSwNP, with plans to initiate development for COPD.