PART I. FINANCIAL INFORMATION Item 1. Financial Statements (Unaudited) Presents the unaudited condensed consolidated financial statements for Upstream Bio, Inc., reporting a $27.3 million net loss and $431.4 million in cash and investments Condensed Consolidated Balance Sheet Data (in thousands) | | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $71,312 | $325,892 | | Short-term investments | $360,068 | $144,559 | | Total current assets | $453,787 | $479,160 | | Total assets | $456,169 | $481,719 | | Liabilities and Stockholders' Equity | | | | Total current liabilities | $9,567 | $10,737 | | Total liabilities | $10,559 | $11,867 | | Total stockholders' equity | $445,610 | $469,852 | | Accumulated deficit | $(218,050) | $(190,780) | Condensed Consolidated Statements of Operations (in thousands) | | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Collaboration revenue | $566 | $640 | | Research and development | $25,797 | $11,691 | | General and administrative | $6,782 | $3,962 | | Loss from operations | $(32,013) | $(15,013) | | Net loss | $(27,270) | $(10,894) | | Net loss per share, basic and diluted | $(0.51) | $(4.68) | Condensed Consolidated Statements of Cash Flows (in thousands) | | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(41,165) | $(17,562) | | Net cash provided by (used in) investing activities | $(213,381) | $13,852 | | Net cash provided by (used in) financing activities | $(34) | $9,387 | Management's Discussion and Analysis of Financial Condition and Results of Operations Discusses the company's financial condition, operational results, and future outlook, highlighting increased R&D expenses and sufficient funding through 2027 - The company is advancing its sole product candidate, verekitug, into Phase 2 trials for severe asthma, CRSwNP, and COPD. Top-line data for the CRSwNP trial is expected in Q3 2025, and for the severe asthma trial in the first half of 2026113 - Based on the current operating plan, the company believes its existing cash, cash equivalents, and short-term investments of $431.4 million as of March 31, 2025, will be sufficient to fund operating expenses and capital expenditure requirements through 2027115165 Comparison of Results of Operations (in thousands) | | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Change | | :--- | :--- | :--- | :--- | | Collaboration revenue | $566 | $640 | $(74) | | Research and development | $25,797 | $11,691 | $14,106 | | General and administrative | $6,782 | $3,962 | $2,820 | | Loss from operations | $(32,013) | $(15,013) | $(17,000) | | Net loss | $(27,270) | $(10,894) | $(16,376) | - R&D expenses increased by $14.1 million YoY, primarily due to a $5.7 million increase for the COPD indication planning, a $3.9 million increase for the asthma indication's Phase 2 trial and LTE study planning, and a $1.2 million increase for the CRSwNP Phase 2 trial148149 - General and administrative expenses increased by $2.8 million YoY, mainly due to a $1.9 million increase in personnel expenses from higher headcount and a $0.6 million increase in corporate insurance and occupancy costs153 Item 3. Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, Upstream Bio, Inc. is not required to provide the information for this item - The company is a smaller reporting company as defined in Rule 12b-2 under the Securities Exchange Act of 1934 and is not required to provide quantitative and qualitative disclosures about market risk182 Item 4. Controls and Procedures Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective as of March 31, 2025. There were no material changes in internal control over financial reporting during the quarter - Management concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of the end of the period covered by the report184 - No changes in internal control over financial reporting occurred during the quarter ended March 31, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls185 PART II. OTHER INFORMATION Item 1. Legal Proceedings The company is not currently a party to any litigation or legal proceedings that are expected to have a material adverse effect on its business - As of the report date, the company is not involved in any legal proceedings that management believes would have a material adverse effect on the business188 Item 1A. Risk Factors Outlines significant risks including limited operating history, dependence on a single product, funding needs, regulatory uncertainties, and reliance on third-party manufacturing - The company is a clinical-stage biopharmaceutical company with a limited operating history and a history of significant financial losses, which are expected to continue for the foreseeable future192 - The company's business is entirely dependent on its only product candidate, verekitug. Any failure or significant delay in its development, regulatory approval, or commercialization would materially harm the business205207 - The company will require additional funding to finance operations. Failure to raise capital when needed could force delays, reductions, or elimination of product development programs197 - The regulatory approval processes of the FDA and other authorities are lengthy, time-consuming, and unpredictable. There is no guarantee that verekitug will obtain regulatory approval243 - The company relies on third parties, such as WuXi Biologics, for manufacturing. Potential U.S. legislation like the BIOSECURE Act could materially impact its agreement with key Chinese manufacturing partners314459 - The company faces risks related to the adoption and use of artificial intelligence (AI), including security risks to confidential information and an uncertain regulatory environment, such as the EU's AI Act239240 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds There were no unregistered sales of equity securities during the period. There has been no material change in the planned use of proceeds from the company's Initial Public Offering (IPO) as described in the final prospectus - There has been no material change in the planned use of proceeds from the IPO declared effective on October 10, 2024480 Item 5. Other Information During the quarter ended March 31, 2025, none of the company's directors or officers adopted, modified, or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement - No director or officer adopted, modified, or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement in Q1 2025484
Upstream Bio, Inc.(UPB) - 2025 Q1 - Quarterly Report