Financial Performance - As of September 30, 2025, the company reported net losses of $33.7 million for the three months ended September 30, 2025, compared to $16.0 million for the same period in 2024, indicating a 110.6% increase in losses year-over-year[114] - The company has incurred significant net operating losses and negative cash flows since inception, with net losses of $101.0 million for the nine months ended September 30, 2025, compared to $41.6 million for the same period in 2024, representing a 142.4% increase[114] - The net loss for the nine months ended September 30, 2025, was $101.0 million, compared to a net loss of $41.6 million in 2024, reflecting an increase of 143.0%[153] Revenue and Collaboration - The company has not generated any revenue from product sales since inception and does not expect to do so in the foreseeable future, relying instead on collaboration revenue from the Maruho License Agreement[129] - During the nine months ended September 30, 2025, the company received $2.1 million from Maruho, compared to $1.2 million during the same period in 2024, reflecting a 75% increase[127] - Collaboration revenue for the three months ended September 30, 2025, was $0.7 million, an increase of 12.5% from $0.6 million in the same period of 2024[146] - For the nine months ended September 30, 2025, collaboration revenue was $2.2 million, up 24.4% from $1.8 million in 2024[154] Expenses - Research and development expenses for the three months ended September 30, 2025, were $33.0 million, up 113.6% from $15.4 million in 2024, primarily due to increased costs associated with the verekitug program[147] - Research and development expenses for the nine months ended September 30, 2025, totaled $96.6 million, a 134.7% increase from $41.2 million in 2024, driven by higher costs in the verekitug program[155] - General and administrative expenses increased to $5.5 million for the three months ended September 30, 2025, compared to $4.1 million in 2024, reflecting a rise of 36.3% driven by higher personnel costs[151] - General and administrative expenses totaled $19.7 million for the nine months ended September 30, 2025, up from $12.0 million in 2024, reflecting a $7.7 million increase[159][160] - Total operating expenses for the nine months ended September 30, 2025, were $116.4 million, a significant increase of 118.9% from $53.2 million in 2024[153] Cash and Investments - The company has an accumulated deficit of $291.8 million and cash, cash equivalents, and short-term investments totaling $372.4 million as of September 30, 2025, which is expected to fund operations through 2027[114] - Net cash used in operating activities was $102.6 million for the nine months ended September 30, 2025, compared to $39.6 million in 2024[164][165] - Net cash used in investing activities was $152.4 million for the nine months ended September 30, 2025, compared to $101.4 million in 2024[168][169] - Interest income rose to $4.1 million for the three months ended September 30, 2025, a 41.4% increase from $2.9 million in 2024, attributed to higher balances in investments[152] - Interest income increased to $13.3 million for the nine months ended September 30, 2025, compared to $7.0 million in 2024, an increase of $6.3 million[162] Future Expectations - The company expects general and administrative expenses to rise as it increases headcount and expands infrastructure to support ongoing research and development[137] - The company anticipates increased R&D and administrative expenses as it advances verekitug through clinical trials and potential future product candidates[172] - The company expects to fund operations through a combination of equity offerings, debt financings, and collaborations, as it does not expect to generate revenue from product sales for several years[172][175] Clinical Development - The company reported positive top-line results in the Phase 2 trial for chronic rhinosinusitis with nasal polyps (CRSwNP) in September 2025 and anticipates reporting data from the severe asthma Phase 2 trial in Q1 2026[112] - Research and development expenses are expected to increase significantly as the company advances verekitug through clinical trials, with costs associated with later-stage trials generally being higher[131] - The company has incurred approximately $86.8 million in direct external expenses for the development of verekitug for severe asthma, COPD, and CRSwNP since their development candidate nominations[158] Agreements and Royalties - The company is required to pay mid-single-digit percentage royalties on aggregate worldwide net sales of any product developed that contains the compound verekitug as an ingredient[124] - The company has entered into multiple agreements, including the Astellas Asset Purchase Agreement and the Maruho License Agreement, to support the development and commercialization of verekitug[120][125] Company Classification - The company is classified as an "emerging growth company" under the JOBS Act, allowing it to adopt new accounting standards at the same time as private companies[190] - The company is also a "smaller reporting company," which may continue if its market value is below $250 million or annual revenue is below $100 million[191] - As a smaller reporting company, the company can present only the two most recent fiscal years of audited financial statements in its Annual Report on Form 10-K[191] - The company has reduced disclosure obligations regarding executive compensation due to its status as a smaller reporting company[191] - The company is not required to provide quantitative and qualitative disclosures about market risk as a smaller reporting company[192]
Upstream Bio, Inc.(UPB) - 2025 Q3 - Quarterly Report