WALTHAM, Mass., June 05, 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 an upcoming presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025 in Glasgow, UK, on Sunday, June 15, 2025. The presentation features translational pharmacology modeling data that supports Thymic Stromal Lymphopoietin (TSLP) receptor targetin ...

A live webcast of the fireside chat will be available under the "Events" tab on the "Investors" page of the Company's website on the day of the event. A replay of the webcast will be posted on the Company's website following the presentation. WALTHAM, Mass., June 04, 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 Executi ...

About Upstream Bio Upstream Bio is a clinical-stage biotechnology company developing treatments for inflammatory diseases, with an initial focus on severe respiratory disorders. The Company is developing verekitug, the only known antagonist currently in clinical development that targets the receptor for thymic stromal lymphopoietin, 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. ...

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 March 31, 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) (State or oth ...

Upstream Bio Reports First Quarter 2025 Financial Results and Accelerates Guidance on All Clinical Programs – Top-line data from Phase 2 clinical trial of verekitug in patients with chronic rhinosinusitis with nasal polyps expected in the third quarter of 2025 – – Top-line data from Phase 2 clinical trial of verekitug in patients with severe asthma now expected in the first half of 2026 – – First patient in Phase 2 clinical trial of verekitug in patients with chronic obstructive pulmonary disease to be dose ...

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Financial Performance - The company reported net losses of $62.8 million and $20.5 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $190.8 million as of December 31, 2024[587]. - The net loss for the year ended December 31, 2024 was $62.8 million, compared to a net loss of $20.5 million in 2023, reflecting an increase of $42.3 million[615]. - The company expects to continue incurring significant net operating losses for the foreseeable future, depending on the timing of expenditures on research and development activities[588]. - The company has incurred significant net operating losses and negative cash flows since inception, indicating a need for additional financing to support ongoing operations[590]. Cash and Investments - The company has cash, cash equivalents, and short-term investments totaling $470.5 million, which are expected to fund operations through 2027[587]. - As of December 31, 2024, the company had cash, cash equivalents, and short-term investments totaling $470.5 million[626]. - The company believes its existing cash, cash equivalents, and short-term investments will fund operating expenses through 2027[638]. Initial Public Offering (IPO) - The company completed its IPO in October 2024, issuing 17,250,000 shares at a public price of $17.00 per share, resulting in net proceeds of $268.8 million after deducting underwriting discounts and commissions[586]. Research and Development - The company is developing verekitug, currently in Phase 2 trials for severe asthma and chronic rhinosinusitis with nasal polyps, with top-line data expected in the second half of 2025 and 2026, respectively[585]. - Research and development expenses are expected to increase as the company advances verekitug through clinical trials, with higher costs anticipated in later stages of development[603]. - Research and development expenses increased to $63.0 million in 2024 from $31.8 million in 2023, driven by a $23.8 million increase in expenses for the verekitug program[617]. - The company expects increased research and development and general administrative expenses as it advances its product candidates through clinical trials[635]. - The company incurred approximately $51.0 million in direct external expenses for the development of verekitug for severe asthma since its nomination[621]. Revenue and Collaboration - The company has not generated any revenue from product sales and does not expect to do so in the foreseeable future, relying on collaboration revenue from the Maruho License Agreement[601]. - Collaboration revenue from related parties was $2.4 million for both years ended December 31, 2024 and 2023, primarily related to clinical trials for severe asthma[616]. Operating Expenses - The total operating expenses for 2024 were $80.1 million, up from $42.5 million in 2023, marking an increase of $37.6 million[615]. - General and administrative expenses rose to $17.2 million in 2024 from $10.7 million in 2023, with personnel expenses increasing by $4.5 million due to higher headcount[622]. - The company expects general and administrative expenses to increase in the future as it expands its infrastructure and headcount to support ongoing research and development[609]. Financing Activities - The company has received total gross proceeds of $400.0 million from the issuance of Series A and Series B redeemable convertible preferred stock[586]. - The company anticipates financing operations through equity offerings, debt financings, and collaborations until substantial product revenue is generated[639]. - The company provided $129.6 million in net cash from financing activities during the year ended December 31, 2023, including $80.0 million from the issuance of Series A Preferred Stock[634]. Lease and Payments - The company entered into a three-year lease agreement for office space with an initial base rent of approximately $0.7 million for the first year[648]. - The company has made annual payments to Lonza of $0.5 million and $0.4 million for the years ended December 31, 2024 and 2023, respectively, related to the Lonza License Agreement[600]. - Annual payments to Lonza under the Lonza License Agreement were $0.4 million for the year ended December 31, 2023[647]. Stock and Valuation - The company issued stock option awards with performance-based vesting conditions to key executives, with stock-based compensation recognized upon achievement of performance conditions in February 2023 and April 2024[657]. - Prior to the IPO in October 2024, the estimated fair value of the company's common stock was determined by the board of directors, considering third-party valuations and other relevant factors[658]. - The company classified Series A and Series B preferred stock tranche rights as liabilities, initially recorded at fair value upon issuance[659]. - Changes in the fair value of preferred stock tranche right liabilities were recognized as a component of other income in the consolidated statements of operations until settled[660]. - The fair value of Series A preferred stock tranche right liability was determined using a probability-weighted expected return method, with significant assumptions impacting valuation[663]. - The fair value of Series B preferred stock tranche right liability was determined using an option pricing model, with the fair value of Series B Preferred Stock as a key assumption[664]. Regulatory and Reporting Status - The company is classified as a "smaller reporting company," with a market value of common stock held by non-affiliates less than $700 million and annual revenue below $100 million[668]. - The company has elected not to "opt out" of the extended transition period for new accounting standards, which may affect comparability with other public companies[667]. - The company may continue to rely on exemptions from certain disclosure requirements as a smaller reporting company, including reduced obligations regarding executive compensation[668]. - The company is not required to provide quantitative and qualitative disclosures about market risk due to its status as a smaller reporting company[669].

Clinical Trials - Upstream Bio completed enrollment in its Phase 2 clinical trial of verekitug for chronic rhinosinusitis with nasal polyps (CRSwNP) in January 2025, with top-line data expected in the second half of 2025[4]. - The company plans to initiate dosing of the first patient in its COPD program in the second half of 2025 and expects to report top-line data from the severe asthma trial in the second half of 2026[3]. Financial Performance - The net loss for Q4 2024 was $21.2 million, compared to a net loss of $11.8 million in Q4 2023, an increase of 80% attributed to higher operating expenses[7]. - Research and development expenses for Q4 2024 were $21.8 million, a 87.9% increase from $11.6 million in Q4 2023, primarily due to clinical and manufacturing costs related to the verekitug program[5]. - General and administrative expenses rose to $5.2 million in Q4 2024, compared to $3.2 million in Q4 2023, reflecting increased personnel-related costs[6]. - Total operating expenses for the year ended December 31, 2024, were $80.1 million, significantly higher than $42.5 million for the year ended December 31, 2023[18]. Funding and Investments - Upstream Bio raised approximately $293 million in gross proceeds from its upsized initial public offering (IPO) completed in October 2024[9]. - The company reported cash, cash equivalents, and short-term investments of $470.5 million as of December 31, 2024, which is projected to fund operations through 2027[5]. - Upstream Bio's total assets increased to $481.7 million as of December 31, 2024, compared to $117.2 million in 2023[16]. Leadership and Management - The company appointed key members to its Board of Directors and management team, enhancing its leadership in the biotechnology sector[9].

Core Insights - Upstream Bio, Inc. has completed enrollment in its Phase 2 clinical trial of verekitug for chronic rhinosinusitis with nasal polyps (CRSwNP), with top-line data expected in the second half of 2025 [1][2] - The company successfully completed an upsized IPO, raising approximately $293 million, which will extend its operational runway through 2027 [1][6] - Upstream is advancing verekitug, a monoclonal antibody targeting the TSLP receptor, in multiple severe respiratory diseases including CRSwNP, severe asthma, and chronic obstructive pulmonary disease (COPD) [1][10] Clinical Development - The Phase 2 trial for CRSwNP is designed to assess the efficacy and safety of verekitug, with patients receiving either 100 mg of the drug or a placebo every 12 weeks over a 24-week period [4] - The primary endpoint of the trial is the change in nasal polyp score (NPS) at week 24, with secondary endpoints including nasal congestion score and time to systemic corticosteroids or surgery [4] - Upstream plans to initiate dosing for its COPD program in the second half of 2025 and expects to report data from the severe asthma trial in the second half of 2026 [3] Financial Performance - As of December 31, 2024, Upstream had cash, cash equivalents, and short-term investments totaling $470.5 million, sufficient to fund operations through 2027 [7] - Research and development expenses for Q4 2024 were $21.8 million, up from $11.6 million in Q4 2023, primarily due to increased clinical and manufacturing costs related to verekitug [7] - The net loss for Q4 2024 was $21.2 million, compared to a net loss of $11.8 million in the same period of 2023, driven by higher operating expenses [9][18] Management and Governance - Upstream made key additions to its Board of Directors and management team, including the appointment of Daniella Beckman as an independent director and chair of the Audit Committee [6] - Allison Ambrose was appointed as General Counsel, bringing extensive legal experience from other biotech companies [6] Upcoming Events - Upstream plans to participate in investor conferences, including the Leerink Partners Global Biopharma Conference and the Piper Sandler Spring Biopharma Symposium [13]

Company Overview - 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 verekitug, a monoclonal antibody targeting the receptor for thymic stromal lymphopoietin, which is involved in inflammatory responses [2] - Verekitug is currently in separate Phase 2 trials for severe asthma and chronic rhinosinusitis with nasal polyps, with plans to initiate development for chronic obstructive pulmonary disease [2] Upcoming Events - Rand Sutherland, MD, CEO of Upstream Bio, will present at the TD Cowen 45th Annual Health Care Conference on March 4, 2025, from 11:50 a.m. to 12:20 p.m. ET [3] - The company will also participate in the Leerink Partners Global Biopharma Conference on March 12, 2025, from 1:40 p.m. to 2:10 p.m. ET [3] - A live webcast of the presentations will be available on the company's website, with replays posted afterward [1]