UpStream Bio Inc.
General Information | |
Business: | (Incorporated in Delaware)We are a clinical-stage biotechnology company developing treatments for inflammatory diseases, with an initial focus on severe respiratory disorders. We are developing verekitug, the only known antagonist currently in clinical development that targets the receptor for Thymic Stromal Lymphopoietin (“TSLP”), a cytokine which is a clinically validated driver of inflammatory response positioned upstream of multiple signaling cascades that affect a variety of immune mediated diseases. Preclinical and clinical data to date demonstrate verekitug’s highly potent inhibition of the TSLP receptor, which we believe will translate to a differentiated product profile, including improved clinical outcomes, substantially extended dosing intervals and the potential to treat a broad spectrum of patients. We have advanced this highly potent monoclonal antibody into separate Phase 2 trials for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps (“CRSwNP”) and plan to initiate development in chronic obstructive pulmonary disease (“COPD”). Our experienced team is committed to maximizing verekitug’s unique attributes to address the substantial unmet needs for patients underserved by today’s standard of care. There are six biologics approved for the treatment of severe asthma; three of these are also approved for CRSwNP, and no biologic is currently approved for COPD. Total estimated biologics sales in 2023 for asthma in the United States, Europe and Japan markets were approximately $7.5 billion. In December 2021, tezepelumab (marketed as Tezspire by Amgen Inc. (“Amgen”) and AstraZeneca PLC (“AstraZeneca”)), a monoclonal antibody targeting the TSLP ligand, not the receptor, was approved by the U.S. Food and Drug Administration (“FDA”) as an add-on maintenance treatment for patients with severe asthma. Tezepelumab is the first and only treatment for severe asthma without any phenotype or biomarker limitation, highlighting the benefit of blocking TSLP signaling early in the inflammatory cascade as compared to other biologics’ mechanisms of action which are further downstream. In May 2024, Amgen and AstraZeneca reported Phase 2a proof-of-concept data for tezepelumab for the treatment of moderate to very severe COPD at the American Thoracic Society (“ATS”) International Conference. This trial reported a reduction in the frequency of COPD exacerbations that has supported advancement of tezepelumab into Phase 3 development for COPD. These clinical data further demonstrate the potential for a TSLP targeted therapy to treat a variety of inflammatory diseases. Despite the availability of existing biologics for severe respiratory disease, there remains a high unmet need that limits the utilization of these therapies, including suboptimal symptom control and frequent dosing intervals. Verekitug is, to our knowledge, the only monoclonal antibody currently in clinical development that targets and inhibits the TSLP receptor. In May 2024, we presented full proof-of-concept data from our multicenter, randomized, double-blind, placebo-controlled Phase 1b multiple ascending dose (“MAD”) clinical trial in asthma patients demonstrating that dosing with verekitug led to rapid and complete TSLP receptor occupancy, and reductions in fractional exhaled nitric oxide (“FeNO,” a disease-related biomarker) and blood eosinophil levels (“eos,” a disease-related biomarker) that were rapid, substantial and sustained for up to 24 weeks after the last dose. This study also demonstrated that verekitug is approximately 300-fold more potent than tezepelumab (based on published tezepelumab data), which, combined with verekitug’s pharmacokinetic (“PK”) profile, enables an extended dosing interval of up to 24 weeks, compared to tezepelumab (four week dosing interval). Furthermore, clinical data from our Phase 1b MAD trial indicate an approximately 50% greater effect on FeNO than has previously been reported for tezepelumab. We have not conducted head-to-head clinical studies of verekitug against tezepelumab, and note that ongoing and future clinical trials for verekitug may produce differing clinical activity and tolerability results. Three Phase 1 clinical trials have been completed for verekitug across a total of 120 participants, including 32 patients with asthma. In these trials, which were not designed to support formal statistical comparisons, verekitug was well tolerated, demonstrated no evidence of clinically meaningful anti-drug antibodies (“ADAs”), and showed a predictable and consistent PK profile with high subcutaneous bioavailability. Although competitive product candidates may be sponsored by organizations with greater financial resources and expertise to support regulatory approval and market acceptance, we believe verekitug, if approved, will be the preferred biologic for the treatment of severe asthma, CRSwNP and COPD based on its extended dosing interval and effect on broadly accepted disease-associated biomarkers. Our current clinical development plan for verekitug is summarized in the pipeline chart below. Having established clinical proof-of-concept in asthma, we are currently conducting two separate multi-national, placebo-controlled, randomized Phase 2 clinical trials to investigate the efficacy of two extended dosing intervals of 12 and 24 weeks for patients with severe asthma and 12 weeks for patients with CRSwNP. These trials have been designed using endpoints that, pending interactions with regulatory authorities, could allow data from these trials to support submissions for product approval. Data from these trials are expected in the second half of 2026 for severe asthma and the second half of 2025 for CRSwNP. Based on available data from Phase 1 trials with verekitug, we plan to initiate our first clinical trial in COPD and have commenced planning activities for a Phase 2 clinical trial, including development of a clinical trial protocol and regulatory approval strategy, and expect to dose the first COPD patient in the second half of 2025. Beyond these indications, we believe verekitug has broad potential, and we intend to leverage its unique attributes to develop it as a potential therapy for numerous TSLP-driven diseases. Note: Net loss and collaboration revenue are for the 12 months that ended June 30, 2024. (Note: UpStream Bio, Inc. filed an S-1/A dated Oct. 7, 2024, and disclosed the terms for its IPO: 12.5 million shares at $15.00 to $17.00 to raise $200 million. Background: UpStream Bio, Inc. filed its S-1 to go public on Sept. 18, 2024, without disclosing terms. Estimated IPO proceeds are $100 million, which is a placeholder amount.) |
Industry: | Pharmaceuticals |
Employees: | 38 |
Founded: | 2021 |
Contact Information | |
Address | 890 Winter Street, Suite 200 Waltham, MA 02451 |
Phone Number | (781) 208-2466 |
Web Address | http://www.upstreambio.com/ |
View Prospectus: | UpStream Bio Inc. |
Financial Information | |
Market Cap | $781.47mil |
Revenues | $2.22 mil (last 12 months) |
Net Income | $-40.51 mil (last 12 months) |
IPO Profile | |
Symbol | UPB |
Exchange | NASDAQ |
Shares (millions): | 12.5 |
Price range | $15.00 - $17.00 |
Est. $ Volume | $200.0 mil |
Manager / Joint Managers | JPMorgan/TD Cowen/Piper Sandler/William Blair |
CO-Managers | |
Expected To Trade: | 10/11/2024 |
Day: | Friday |
Quiet Period Expiration Date: | Available only to Subscribers |
Lock-Up Period Expiration Date: | Available only to Subscribers |
SCOOP Rating | Available only to Subscribers |
Rating Change | Available only to Subscribers |