UPB — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-11

• The following table summarizes our results of operations for the three months ended June 30, 2026 and 2025:

• Collaboration revenue for the three months ended June 30, 2026 and 2025 was $0.8 million and $0.9 million, respectively. Revenue during each of the three months ended June 30, 2026 and 2025 was related to the work performed associated with our Phase 2 clinical trial and Phase 2 LTE study in patients…

• Research and development expenses were $36.1 million for the three months ended June 30, 2026 compared to $37.9 million for the three months ended June 30, 2025. The decrease of $1.8 million was primarily driven by a decrease of $2.8 million in unallocated research and development expenses, partiall…

• The increase in direct costs of $1.5 million related to the COPD indication was primarily due to the continued progress associated with our Phase 2 clinical trial during the three months ended June 30, 2026, compared to the same period in 2025. The decrease in direct costs of $0.3 million related to…

• The decrease in manufacturing costs of $5.9 million was primarily attributable to a decrease in CMO costs in support of the development of Phase 3 clinical material during the three months ended June 30, 2026, compared to the same period in 2025. The increase in personnel expenses of $2.4 million wa…

Text removed vs the prior filing · source: 10-Q · 2026-05-13

• Comparison of the three months ended March 31, 2026 and 2025

• The following table summarizes our results of operations for the three months ended March 31, 2026 and 2025:

• Collaboration revenue for the three months ended March 31, 2026 and 2025 was $1.0 million and $0.6 million, respectively. Revenue during each of the three months ended March 31, 2026 and 2025 was related to the work performed associated with our Phase 2 clinical trial and Phase 2 LTE study in patien…

• Research and development expenses were $36.6 million for the three months ended March 31, 2026 compared to $25.8 million for the three months ended March 31, 2025. The increase of $10.8 million was primarily driven by an increase of $4.3 million in expenses directly related to our verekitug program …

• The increase in direct costs of $5.3 million related to the COPD indication was primarily due to the continued progress associated with our Phase 2 clinical trial during the three months ended March 31, 2026, compared to the same period in 2025. The increase in direct costs of $0.7 million related t…

Text added vs the prior filing · source: 10-Q · 2026-08-11

• Clinical testing is expensive, difficult to design and implement, can take many years to complete and is inherently uncertain as to outcome. The general approach for FDA approval of a new drug has generally been dispositive data from two or more adequate and well-controlled clinical trials of the pr…

• commercialization. Any of the foregoing scenarios could materially harm the commercial prospects for verekitug or any other potential future product candidates.

• We currently rely on and engage third-party manufacturers to provide all of the APIs and the final drug product formulation of verekitug that is being used in our clinical trials and preclinical studies, including WuXi Biologics (Hong Kong) Limited (“WuXi Biologics”). While WuXi Biologics is not cur…

• Although the BIOSECURE Act includes certain exceptions, waivers, and safe harbors, including a transition period for existing contracts following the issuance of implementing regulations, these provisions may be limited in scope, subject to agency interpretation, or unavailable in particular circums…

• through final regulations, and the manner in which U.S. government agencies will interpret and enforce these restrictions remains uncertain.

Text removed vs the prior filing · source: 10-Q · 2026-05-13

• Clinical testing is expensive, difficult to design and implement, can take many years to complete and is inherently uncertain as to outcome. The general approach for FDA approval of a new drug has generally been dispositive data from two or more adequate and well-controlled clinical trials of the pr…

• Although the BIOSECURE Act includes certain exceptions, waivers, and safe harbors, including a transition period for existing contracts following the issuance of implementing regulations, these provisions may be limited in scope, subject to agency interpretation, or unavailable in particular circums…

• If WuXi, or any other current or future vendors with which we work are designated as BCCs, or if our collaborators, customers, investors, or future commercial partners become subject to BIOSECURE-related restrictions as a result of their relationships with such vendors, we could be required to termi…

• Any regulatory approvals that we receive for verekitug or any other potential future product candidates may be subject to limitations on the approved indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing t…

• Additionally, the new administration could issue or promulgate executive orders, regulations, policies or guidance that adversely affect us or create a more challenging or costly environment to pursue the development of new therapeutic candidates.