APVO — what changed in the latest 10-Q

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

• Along with our clinical candidates, the preclinical candidates, APVO603 and APVO711, were also developed using our ADAPTIR® protein technology platform. Our preclinical candidates APVO442, APVO455, APVO451 and APVO452 were developed using our ADAPTIR-FLEX® protein technology platform. We wholly own …

• RAINIER trial on track for completion and Phase 2 dose selection by year end.

• Mipletamig continues to generate strong data in frontline acute myeloid leukemia (AML) in combination with venetoclax + azacitidine. Across 31 evaluable patients (includes data through RAINIER Cohort 5, plus 4 patients from the previously completed dose expansion trial), the data has demonstrated co…

• 87% clinical benefit rate* demonstrates broad anti-leukemia activity and blast reduction across response categories

• 81% CR or CRi (remission), compared to 66.4% in the Phase 3 VIALE-A trial**

Text removed vs the prior filing · source: 10-Q · 2025-11-06

• Preclinical candidates, APVO603, a dual agonist bispecific designed to simultaneously target 4-1BB (CD137) and OX40 (CD134), and APVO711, a bispecific checkpoint inhibitor with added functionality that targets PD-L1 and CD40, were also developed using our ADAPTIR modular protein technology platform.…

• over monoclonal antibodies allow for the development of immunotherapies that are designed to engage immune effector cells and disease targets to produce signaling responses that modulate the immune system to kill tumor cells. We believe we are skilled at candidate generation, validation, and subsequ…

• 89% remission* reported among evaluable frontline AML patients across two trials treated with mipletamig in combination therapy, including 100% remission in Cohort 3 in the ongoing RAINIER trial (*Remission = complete remission (CR) and, complete remission with blood markers that have not yet recove…

• No cytokine release syndrome (CRS) observed among evaluable frontline patients to date — a meaningful distinction in a category where CRS is a common and often dose-limiting toxicity

• Introduced the Company’s first trispecific T-cell engagers — APVO451 and APVO452 — expanding the oncology portfolio to five CRIS-7-derived CD3-targeting molecules

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

• Accounting Standards Update (ASU 2014-15) requires management to assess our ability to continue as a going concern for one year after the date the financial statements are issued. As further discussed in Note 1, Nature of Business and Significant Accounting Policies to our consolidated financial sta…

• the level, timing and receipt of any milestone payments under our agreements with Medexus with respect to the sales of IXINITY.

• Various macroeconomic factors and political events have in the past and could adversely affect in the future our business and the results of our operations and financial condition, including changes in inflation, interest rates and overall economic conditions and uncertainties such as those resultin…

• products, which may lead to unpredictable economic consequences including inflation or trade wars. For example, inflation has negatively impacted the Company by increasing our labor costs through higher wages and operating costs. Supply chain constraints have led to higher inflation, which if sustai…

• Due to the macroeconomic and geopolitical environment, we may experience delays in opportunities to partner our product candidates, due to financial and other impacts on potential partners. Additionally, we may experience potential impacts on our future milestone payments from Medexus, which may imp…

Text removed vs the prior filing · source: 10-Q · 2025-11-06

• Our future ability to continue as a going concern will require us to generate positive cash flow from operations, obtain additional financing, enter into strategic alliances and/or sell assets in addition to our existing cash and cash equivalents and the funding provided by our Purchase Agreement wi…

• the level, timing and receipt of any milestone payments under our agreements with Medexus with respect to the sales of IXINITY;

• Various macroeconomic factors and political events have in the past and could adversely affect in the future our business and the results of our operations and financial condition, including changes in inflation, interest rates and overall economic conditions and uncertainties such as those resultin…

• Due to the macroeconomic and geopolitical environment, we may experience delays in opportunities to partner our product candidates, due to financial and other impacts on potential partners. Additionally, we may experience potential impacts on our future

• milestone payments from Medexus, which may impact Medexus' ability to continue to successfully commercialize the IXINITY businesses. These and other factors may have a material adverse effect on our business, results of operations and financial condition.